Trial Outcomes & Findings for Enhancing Parenting for Depressed Caregivers (NCT NCT01464619)
NCT ID: NCT01464619
Last Updated: 2016-04-11
Results Overview
Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
3 months
Results posted on
2016-04-11
Participant Flow
Participant milestones
| Measure |
Intervention
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Intervention
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Enhancing Parenting for Depressed Caregivers
Baseline characteristics by cohort
| Measure |
Delayed Intervention
n=29 Participants
Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment.
Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment.
|
Intervention
n=32 Participants
Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls.
The Incredible Years Parenting Intervention: The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Original number who enrolled and were assigned to each group.
Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.
Outcome measures
| Measure |
Intervention
n=32 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=29 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Feasibility of a Parent Coaching Intervention
|
6 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 monthsChange from baseline to follow-up of the Beck Depression Scale-II (BDI-II), a validated self-report measure of depressive symptoms. The scale range is from 0 to 63 with higher scores indicating worse depressive symptoms.
Outcome measures
| Measure |
Intervention
n=29 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=25 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Change in Caregiver Depressive Symptoms
|
-7.6 units on a scale
Standard Deviation 8.2
|
-6.2 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: No satisfaction measures were collected from the control group, as they received the intervention in a delayed format after their study participation had ended.
Acceptability of the parent coaching intervention will be assessed by a response to the question "How did you like the parenting program?" at the conclusion of the parent sessions. the responses ranged from 1 (highly disliked) to 5 (highly liked)
Outcome measures
| Measure |
Intervention
n=16 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Acceptability of the Parent Coaching Intervention
|
4.75 units on a scale
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: 3 monthsFeasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.
Outcome measures
| Measure |
Intervention
n=32 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=29 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Attendance at 6 or More Incredible Years (IY) Sessions
|
31.3 percentage of subjects enrolled
|
13.8 percentage of subjects enrolled
|
SECONDARY outcome
Timeframe: 3 monthsFeasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.
Outcome measures
| Measure |
Intervention
n=32 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=29 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.
|
19 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 3 monthsChange from baseline to follow-up of the Parenting Stress Index-Short Form Total (PSI-SF), a validated self-report measure of parenting stress. Total scores range from 36 to 180 with higher scores indicating greater levels of parenting stress.
Outcome measures
| Measure |
Intervention
n=29 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=25 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Change in Parenting Stress
|
-8.9 units on a scale
Standard Deviation 27.9
|
-6.1 units on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: 3 monthsChange from baseline to follow-up of the Multidimensional Scale of Perceived Social Support (MSPSS), a validated self-report measure of perceived social support from family, friends, and a significant other. Total scores range from 12 to 84 with higher scores indicating greater perceived social support.
Outcome measures
| Measure |
Intervention
n=29 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=25 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Change in Social Support
|
0.4 units on a scale
Standard Deviation 1.2
|
0.3 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 3 monthsChange from baseline to follow-up of the Parenting Scale (PS), a validated self-report measure of parents' self-reported parenting discipline. Total scores range from 1 to 7 with lower scores indicating better parenting discipline.
Outcome measures
| Measure |
Intervention
n=29 Participants
Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
Delayed Intervention
n=25 Participants
Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
|
|---|---|---|
|
Change in Parenting Discipline
|
-0.3 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.5
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James Guevara, MD, MPH
The Children's Hospital of Philadelphia
Phone: 215-590-1130
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place