Trial Outcomes & Findings for Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers (NCT NCT03916146)
NCT ID: NCT03916146
Last Updated: 2026-03-27
Results Overview
parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
295 participants
Primary outcome timeframe
6 months after parent baseline
Results posted on
2026-03-27
Participant Flow
Aim 2 participants were recruited for parent interviews and stakeholder focus groups. Participant recruitment for the Aim 4 clinical trial began in June 2021 and ended in April 2024. Recruitment for Aim 5 is still active.
Aim 4 was the clinical trial in this study. Parents of 3 to 6 year-old deaf or hard of hearing children enrolled themselves and their children in the study. After parents and children completed baseline data collection, they were randomized to either the intervention group (71 families=142 parents \& children) or the control group (54 families=108 parents \& children). 18 parents that completed Aim 4 were later enrolled in Aim 5 (not double counted) which makes the total enrollment 295.
Participant milestones
| Measure |
Aim 2 Interviews and Focus Groups for Intervention Adaptation
Qualitative data were collected from parents and stakeholders to inform adaptation of the intervention.
|
Aim 4 Behavioral Parent Training
Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention
|
Aim 4 Control
No intervention
|
Aim 5 Implementation Data
Process data and qualitative data from parents, interventionists, and stakeholders described implementation.
|
|---|---|---|---|---|
|
Adaptation Phase
STARTED
|
35
|
0
|
0
|
0
|
|
Adaptation Phase
COMPLETED
|
35
|
0
|
0
|
0
|
|
Adaptation Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Effectiveness Phase
STARTED
|
0
|
142
|
108
|
0
|
|
Effectiveness Phase
COMPLETED
|
0
|
124
|
106
|
0
|
|
Effectiveness Phase
NOT COMPLETED
|
0
|
18
|
2
|
0
|
|
Implementation Phase
STARTED
|
0
|
0
|
0
|
28
|
|
Implementation Phase
COMPLETED
|
0
|
0
|
0
|
26
|
|
Implementation Phase
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Aim 2 Interviews and Focus Groups for Intervention Adaptation
Qualitative data were collected from parents and stakeholders to inform adaptation of the intervention.
|
Aim 4 Behavioral Parent Training
Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention
|
Aim 4 Control
No intervention
|
Aim 5 Implementation Data
Process data and qualitative data from parents, interventionists, and stakeholders described implementation.
|
|---|---|---|---|---|
|
Effectiveness Phase
Withdrawal by Subject
|
0
|
8
|
2
|
0
|
|
Effectiveness Phase
Lost to Follow-up
|
0
|
10
|
0
|
0
|
|
Implementation Phase
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
Baseline characteristics by cohort
| Measure |
Aim 2 Interviews and Focus Groups for Intervention Adaptation
n=35 Participants
Qualitative data were collected from parents and stakeholders to inform adaptation of the intervention.
|
Aim 4 Behavioral Parent Training
n=142 Participants
Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention
|
Aim 4 Control
n=108 Participants
No intervention
|
Aim 5 Implementation Data
n=10 Participants
Process data and qualitative data from parents, interventionists, and stakeholders described implementation.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Parents
|
34.55 years
STANDARD_DEVIATION 5.98 • n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
35.18 years
STANDARD_DEVIATION 5.71 • n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
35.83 years
STANDARD_DEVIATION 5.45 • n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
—
|
35.33 years
STANDARD_DEVIATION 5.63 • n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
|
Age, Continuous
Children
|
—
|
4.99 years
STANDARD_DEVIATION 1.24 • n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
5.02 years
STANDARD_DEVIATION 1.14 • n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
—
|
5.01 years
STANDARD_DEVIATION 1.19 • n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
|
Age, Continuous
Interventionists
|
—
|
—
|
—
|
43.20 years
STANDARD_DEVIATION 12.02 • n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
43.20 years
STANDARD_DEVIATION 12.02 • n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group.
|
|
Sex: Female, Male
Parents · Female
|
19 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
70 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
52 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
141 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Parents · Male
|
1 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
1 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
2 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
4 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Children · Female
|
—
|
40 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
25 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
65 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Children · Male
|
—
|
31 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
29 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
60 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Interventionists · Female
|
—
|
—
|
—
|
10 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
10 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Interventionists · Male
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Stakeholders · Female
|
15 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
15 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Sex: Female, Male
Stakeholders · Male
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Parents · Hispanic or Latino
|
0 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
4 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
3 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
7 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Parents · Not Hispanic or Latino
|
20 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
67 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
51 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
138 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Parents · Unknown or Not Reported
|
0 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
0 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Children · Hispanic or Latino
|
—
|
5 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
4 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
9 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Children · Not Hispanic or Latino
|
—
|
65 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
50 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
115 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Children · Unknown or Not Reported
|
—
|
1 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
1 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Interventionists · Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Interventionists · Not Hispanic or Latino
|
—
|
—
|
—
|
10 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
10 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Interventionists · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Stakeholders · Hispanic or Latino
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Stakeholders · Not Hispanic or Latino
|
15 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
15 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Ethnicity (NIH/OMB)
Stakeholders · Unknown or Not Reported
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · American Indian or Alaska Native
|
0 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
0 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · Asian
|
0 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
2 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
2 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
0 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · Black or African American
|
2 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
4 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
4 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
10 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · White
|
17 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
63 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
46 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
126 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · More than one race
|
1 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
4 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
2 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
7 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Parents · Unknown or Not Reported
|
0 Participants
n=20 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
0 Participants
n=145 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · American Indian or Alaska Native
|
—
|
1 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
1 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · Asian
|
—
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
1 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
1 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
0 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · Black or African American
|
—
|
3 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
4 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
7 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · White
|
—
|
56 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
43 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
99 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · More than one race
|
—
|
8 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
6 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
14 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Children · Unknown or Not Reported
|
—
|
3 Participants
n=71 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=54 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
3 Participants
n=125 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · Asian
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · Black or African American
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · White
|
—
|
—
|
—
|
10 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
10 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · More than one race
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Interventionists · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
0 Participants
n=10 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · American Indian or Alaska Native
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · Asian
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · Black or African American
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · White
|
15 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
15 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · More than one race
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Race (NIH/OMB)
Stakeholders · Unknown or Not Reported
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
—
|
—
|
—
|
0 Participants
n=15 Participants • 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately.
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
142 participants
n=142 Participants
|
108 participants
n=108 Participants
|
10 participants
n=10 Participants
|
295 participants
n=295 Participants
|
PRIMARY outcome
Timeframe: 6 months after parent baselinePopulation: Parents completed the primary outcome measure (PARYC). 4 parents from the intervention arm withdrew or were lost-to-follow-up by the 6-month follow-up appointment (primary endpoint).
parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices
Outcome measures
| Measure |
Behavioral Parent Training
n=67 Participants
Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention
|
Control
n=54 Participants
No intervention
|
|---|---|---|
|
Parenting Young Children (PARYC) Scale
|
5.93 score on a scale
Standard Deviation 0.67
|
5.53 score on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baselinesubscale and total scores
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baselineparent-report self-efficacy and satisfaction with the parenting role
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineobservational measure of parent-child interaction quality
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baselineparent-report depressive symptoms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineparent-report motivation to change parenting behaviors
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months, 18 months, 30 months after parent baselineparent-report satisfaction with intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineparent-report use of hearing aids by child
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baselineWhile the primary study outcomes is PARYC scores 6 months after baseline, we will also assess differences in changes over 3 years in PARYC scores within and between study arms
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineas available from audiological medical records
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineparent-report of children's developing abilities in early language
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months, 24 months, 36 months after parent baselinemeasure of child's receptive language
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineassessment of language pragmatics for children
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months, 24 months, 36 months (children ages 3 years +) after parent baselineassessment of child's intelligibility
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months, 24 months, 36 months after parent baselineparent report of child's language skills in real-world situations
Outcome measures
Outcome data not reported
Adverse Events
Behavioral Parent Training
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral Parent Training
n=71 participants at risk
Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention
|
Control
n=54 participants at risk
No intervention
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
7.0%
5/71 • Number of events 5 • 36 months
One data instrument, the Beck Depression Inventory II, including a question about suicidal thoughts or wishes. Parent participants completed this questionnaire, and safety protocols were created to immediately alert the research team if a parent endorsed suicidal ideation. Adverse Event data were not collected for Child participants, Aim 2 or Aim 5 participants.
|
5.6%
3/54 • Number of events 6 • 36 months
One data instrument, the Beck Depression Inventory II, including a question about suicidal thoughts or wishes. Parent participants completed this questionnaire, and safety protocols were created to immediately alert the research team if a parent endorsed suicidal ideation. Adverse Event data were not collected for Child participants, Aim 2 or Aim 5 participants.
|
Additional Information
Dr. Christina Studts
University of Colorado - Anschutz Medical Campus
Phone: 303-724-2495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place