Trial Outcomes & Findings for Families Together: Intervention for Reunified Families (NCT NCT04382677)

NCT ID: NCT04382677

Last Updated: 2026-04-14

Results Overview

Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

264 participants

Primary outcome timeframe

6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Results posted on

2026-04-14

Participant Flow

Recruitment took place between 12/2017 and 5/2023 in collaboration with the Washington State Department of Children, Youth, \& Families (DCYF). A DCYF study liaison mailed opt-out letters to birth parents recently reunified with a child aged 1-5 years after a foster care placement (open case in Trial Return Home status), living in the greater Seattle, WA area. Parents who did not opt out were contacted by a study recruiter, screened for eligibility, and enrolled in the study.

Of the eligible parent-child dyads (N=427), 264 dyads enrolled:1 parent and 1 child each equating to 528 total parent and child participants.

Participant milestones

Participant milestones
Measure
Promoting First Relationships
The PFR program designed for birth parents being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Baseline Observation
STARTED
132
132
Baseline Observation
COMPLETED
132
132
Baseline Observation
NOT COMPLETED
0
0
Intervention
STARTED
109
127
Intervention
COMPLETED
68
104
Intervention
NOT COMPLETED
41
23
Post-intervention Follow-up
STARTED
118
117
Post-intervention Follow-up
COMPLETED
93
98
Post-intervention Follow-up
NOT COMPLETED
25
19

Reasons for withdrawal

Reasons for withdrawal
Measure
Promoting First Relationships
The PFR program designed for birth parents being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Post-intervention Follow-up
Lost to Follow-up
18
9
Intervention
Withdrawal by Subject
2
1
Intervention
Busy, competing demands
19
0
Intervention
Lost to Follow-up
10
4
Intervention
Became ineligible-out of area, not parenting
4
5
Intervention
Dropped due to COVID-19 pause
6
13
Post-intervention Follow-up
Death
0
1
Post-intervention Follow-up
Withdrawal by Subject
0
1
Post-intervention Follow-up
Became ineligible-not parenting
7
8

Baseline Characteristics

Data reported for parents and children separately

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Promoting First Relationships
n=264 Participants
The PFR program designed for birth parents being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=264 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Total
n=528 Participants
Total of all reporting groups
Age, Continuous
Parents
30.99 Years
STANDARD_DEVIATION 6.663 • n=132 Participants • Data reported for parents and children separately
32.98 Years
STANDARD_DEVIATION 5.463 • n=132 Participants • Data reported for parents and children separately
31.99 Years
STANDARD_DEVIATION 6.162 • n=264 Participants • Data reported for parents and children separately
Age, Continuous
Children
2.538 Years
STANDARD_DEVIATION 1.378 • n=132 Participants • Data reported for parents and children separately
2.545 Years
STANDARD_DEVIATION 1.405 • n=132 Participants • Data reported for parents and children separately
2.542 Years
STANDARD_DEVIATION 1.389 • n=264 Participants • Data reported for parents and children separately
Sex: Female, Male
Parents · Female
107 Participants
n=132 Participants • Data reported for parents and children separately
109 Participants
n=132 Participants • Data reported for parents and children separately
216 Participants
n=264 Participants • Data reported for parents and children separately
Sex: Female, Male
Parents · Male
25 Participants
n=132 Participants • Data reported for parents and children separately
23 Participants
n=132 Participants • Data reported for parents and children separately
48 Participants
n=264 Participants • Data reported for parents and children separately
Sex: Female, Male
Children · Female
62 Participants
n=132 Participants • Data reported for parents and children separately
64 Participants
n=132 Participants • Data reported for parents and children separately
126 Participants
n=264 Participants • Data reported for parents and children separately
Sex: Female, Male
Children · Male
70 Participants
n=132 Participants • Data reported for parents and children separately
68 Participants
n=132 Participants • Data reported for parents and children separately
138 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · American Indian or Alaska Native
6 Participants
n=132 Participants • Data reported for parents and children separately
7 Participants
n=132 Participants • Data reported for parents and children separately
13 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · Asian
1 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=132 Participants • Data reported for parents and children separately
1 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · Native Hawaiian or Other Pacific Islander
3 Participants
n=132 Participants • Data reported for parents and children separately
2 Participants
n=132 Participants • Data reported for parents and children separately
5 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · Black or African American
14 Participants
n=132 Participants • Data reported for parents and children separately
17 Participants
n=132 Participants • Data reported for parents and children separately
31 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · White
83 Participants
n=132 Participants • Data reported for parents and children separately
85 Participants
n=132 Participants • Data reported for parents and children separately
168 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · More than one race
25 Participants
n=132 Participants • Data reported for parents and children separately
21 Participants
n=132 Participants • Data reported for parents and children separately
46 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Parents · Unknown or Not Reported
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · American Indian or Alaska Native
4 Participants
n=132 Participants • Data reported for parents and children separately
5 Participants
n=132 Participants • Data reported for parents and children separately
9 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · Asian
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · Native Hawaiian or Other Pacific Islander
2 Participants
n=132 Participants • Data reported for parents and children separately
1 Participants
n=132 Participants • Data reported for parents and children separately
3 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · Black or African American
14 Participants
n=132 Participants • Data reported for parents and children separately
11 Participants
n=132 Participants • Data reported for parents and children separately
25 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · White
70 Participants
n=132 Participants • Data reported for parents and children separately
72 Participants
n=132 Participants • Data reported for parents and children separately
142 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · More than one race
42 Participants
n=132 Participants • Data reported for parents and children separately
43 Participants
n=132 Participants • Data reported for parents and children separately
85 Participants
n=264 Participants • Data reported for parents and children separately
Race (NIH/OMB)
Children · Unknown or Not Reported
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=264 Participants • Data reported for parents and children separately
Ethnicity (NIH/OMB)
Parents · Hispanic or Latino
16 Participants
n=132 Participants • Data reported for parents and children separately
12 Participants
n=132 Participants • Data reported for parents and children separately
28 Participants
n=264 Participants • Data reported for parents and children separately
Ethnicity (NIH/OMB)
Parents · Not Hispanic or Latino
116 Participants
n=132 Participants • Data reported for parents and children separately
120 Participants
n=132 Participants • Data reported for parents and children separately
236 Participants
n=264 Participants • Data reported for parents and children separately
Ethnicity (NIH/OMB)
Parents · Unknown or Not Reported
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=264 Participants • Data reported for parents and children separately
Ethnicity (NIH/OMB)
Children · Hispanic or Latino
26 Participants
n=132 Participants • Data reported for parents and children separately
25 Participants
n=132 Participants • Data reported for parents and children separately
51 Participants
n=264 Participants • Data reported for parents and children separately
Ethnicity (NIH/OMB)
Children · Not Hispanic or Latino
106 Participants
n=132 Participants • Data reported for parents and children separately
107 Participants
n=132 Participants • Data reported for parents and children separately
213 Participants
n=264 Participants • Data reported for parents and children separately
Ethnicity (NIH/OMB)
Children · Unknown or Not Reported
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=132 Participants • Data reported for parents and children separately
0 Participants
n=264 Participants • Data reported for parents and children separately
Dyad enrolled relative to COVID-19 pandemic
Enrolled prior to COVID-19
85 dyads
n=132 Participants • Data reported for the dyad as the analysis population
83 dyads
n=132 Participants • Data reported for the dyad as the analysis population
168 dyads
n=264 Participants • Data reported for the dyad as the analysis population
Dyad enrolled relative to COVID-19 pandemic
Enrolled after COVID-19 pause
47 dyads
n=132 Participants • Data reported for the dyad as the analysis population
49 dyads
n=132 Participants • Data reported for the dyad as the analysis population
96 dyads
n=264 Participants • Data reported for the dyad as the analysis population

PRIMARY outcome

Timeframe: 18 months post enrollment in the study

Population: Outcome measure assessed only in children who were not dropped due to COVID-19 pandemic. N for this outcome is 240 children.

Official child welfare administrative records indicating whether the child in they dyad was removed from the birth parent home. 18 months post enrollment is approximately 1 year post intervention for those who completed interventions on schedule

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=121 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=119 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Child Welfare Services Removal From Birth Parent Home
12 Participants
19 Participants

PRIMARY outcome

Timeframe: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

Population: Outcome measure assessed only in parents, number of participants analyzed reflect total parent participants assessed for this outcome. Technically, the models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases who with nonmissing data for follow-up scores.

Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Baseline
27.82 scores on a scale
Standard Deviation 3.56
27.91 scores on a scale
Standard Deviation 3.70
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Post-intervention follow-up
28.44 scores on a scale
Standard Deviation 3.59
28.05 scores on a scale
Standard Deviation 3.36

PRIMARY outcome

Timeframe: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Population: Outcome measure assessed only in parents, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
Baseline
27.82 scores on a scale
Standard Deviation 3.56
27.91 scores on a scale
Standard Deviation 3.70
Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)
6-month follow-up
28.32 scores on a scale
Standard Deviation 3.45
27.94 scores on a scale
Standard Deviation 3.21

PRIMARY outcome

Timeframe: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

Population: Outcome measure assessed only in parents, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Parenting Knowledge of Child Development
Baseline
44.64 scores on a scale
Standard Deviation 3.92
45.66 scores on a scale
Standard Deviation 4.04
Change in Parenting Knowledge of Child Development
Post-intervention follow-up
44.61 scores on a scale
Standard Deviation 3.35
45.56 scores on a scale
Standard Deviation 4.13

PRIMARY outcome

Timeframe: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Population: Outcome measure assessed only in parents, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Parenting Knowledge of Child Development
Baseline
44.64 scores on a scale
Standard Deviation 3.92
45.66 scores on a scale
Standard Deviation 4.04
Change in Parenting Knowledge of Child Development
6-month follow-up
43.46 scores on a scale
Standard Deviation 3.48
44.52 scores on a scale
Standard Deviation 4.03

SECONDARY outcome

Timeframe: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

Population: Outcome measure assessed only in parent's report of child, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

Child externalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The externalizing scale has 24 items; raw scores can range from 0 to 48 with higher scores indicating more externalizing behaviors.

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Child Externalizing Problem Behavior
Baseline
17.11 scores on a scale
Standard Deviation 9.38
17.73 scores on a scale
Standard Deviation 8.53
Change in Child Externalizing Problem Behavior
Post intervention
17.71 scores on a scale
Standard Deviation 8.86
17.16 scores on a scale
Standard Deviation 8.09

SECONDARY outcome

Timeframe: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Population: Outcome measure assessed only in parent's report of child, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

Child externalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The externalizing scale has 24 items; raw scores can range from 0 to 48 with higher scores indicating more externalizing behaviors.

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Child Externalizing Problem Behavior
Baseline
17.11 scores on a scale
Standard Deviation 9.38
17.73 scores on a scale
Standard Deviation 8.53
Change in Child Externalizing Problem Behavior
6-month follow-up
19.07 scores on a scale
Standard Deviation 8.92
17.56 scores on a scale
Standard Deviation 8.66

SECONDARY outcome

Timeframe: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

Population: Outcome measure assessed only in parent's report of child, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

Child internalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The internalizing scale has 36 items; raw scores can range from 0 to 72 with higher scores indicating more internalizing behaviors.

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Child Internalizing Problem Behavior
Baseline
10.87 scores on a scale
Standard Deviation 7.68
11.68 scores on a scale
Standard Deviation 8.46
Change in Child Internalizing Problem Behavior
Post-intervention follow-up
10.46 scores on a scale
Standard Deviation 7.09
12.04 scores on a scale
Standard Deviation 7.58

SECONDARY outcome

Timeframe: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Population: Outcome measure assessed only in parent's report of child, number of participants analyzed reflect total parent participants assessed for this outcome. The models used full information maximum likelihood estimation and included cases with partial data (i.e., baseline scores but no follow-up scores) and help reduce bias due to attrition that is associated with nonmissing data on model covariates. The effective sample size, however, is the number of cases with nonmissing data for follow-up scores.

Child internalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach \& Rescorla, 2000). The internalizing scale has 36 items; raw scores can range from 0 to 72 with higher scores indicating more internalizing behaviors.

Outcome measures

Outcome measures
Measure
Promoting First Relationships
n=119 Participants
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral
n=121 Participants
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Change in Child Internalizing Problem Behavior
Baseline
10.87 scores on a scale
Standard Deviation 7.68
11.68 scores on a scale
Standard Deviation 8.46
Change in Child Internalizing Problem Behavior
6-month follow-up
11.82 scores on a scale
Standard Deviation 7.52
11.74 scores on a scale
Standard Deviation 8.22

Adverse Events

Promoting First Relationships - Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Promoting First Relationships - Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Resource & Referral - Parents

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Resource & Referral - Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Promoting First Relationships - Parents
n=132 participants at risk
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Promoting First Relationships - Children
n=132 participants at risk
The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.
Resource & Referral - Parents
n=132 participants at risk
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
Resource & Referral - Children
n=132 participants at risk
The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.
General disorders
Death
0.00%
0/132 • From enrollment until end of 6-month post-intervention follow-up
All serious adverse events are reported regardless of relatedness to the study intervention. Both groups received positive services and no physical/medical intervention. No one was at risk for a serious adverse event or mortality from this behavioral positive parenting program. In attempting to locate a parent for the final data collection, we found their name listed as deceased in vital records. Data represent individual parents and children enrolled as dyads.
0.00%
0/132 • From enrollment until end of 6-month post-intervention follow-up
All serious adverse events are reported regardless of relatedness to the study intervention. Both groups received positive services and no physical/medical intervention. No one was at risk for a serious adverse event or mortality from this behavioral positive parenting program. In attempting to locate a parent for the final data collection, we found their name listed as deceased in vital records. Data represent individual parents and children enrolled as dyads.
0.76%
1/132 • From enrollment until end of 6-month post-intervention follow-up
All serious adverse events are reported regardless of relatedness to the study intervention. Both groups received positive services and no physical/medical intervention. No one was at risk for a serious adverse event or mortality from this behavioral positive parenting program. In attempting to locate a parent for the final data collection, we found their name listed as deceased in vital records. Data represent individual parents and children enrolled as dyads.
0.00%
0/132 • From enrollment until end of 6-month post-intervention follow-up
All serious adverse events are reported regardless of relatedness to the study intervention. Both groups received positive services and no physical/medical intervention. No one was at risk for a serious adverse event or mortality from this behavioral positive parenting program. In attempting to locate a parent for the final data collection, we found their name listed as deceased in vital records. Data represent individual parents and children enrolled as dyads.

Other adverse events

Adverse event data not reported

Additional Information

Monica L. Oxford, Executive Director, Barnard Center for Infant and Early Childhood Mental Health

University of Washington

Phone: 206-685-6107

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place