Trial Outcomes & Findings for Collaborative Perinatal Mental Health and Parenting Support in Primary Care (NCT NCT02724774)
NCT ID: NCT02724774
Last Updated: 2021-12-15
Results Overview
Nursing Child Assessment Teaching Scale: coded from observation of mother interacting with the infant during teaching task. The parenting sensitivity score can range from 0 to 50; higher scores indicate greater sensitivity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Baseline to infant age 12 months
Results posted on
2021-12-15
Participant Flow
Recruitment was conducted in collaboration with the Mental Health Integration Program (MHIP) and Maternity Support Services (MSS) of Public Health Seattle and King County, Washington. Five community health clinics offering MHIP agreed to assist in study recruitment. Eligible participants received mental health treatment during pregnancy, spoke English or Spanish, had an infant under three months, had a telephone, and were planning to remain in the study area until the child's first birthday.
599 cases were screened for eligibility. 353 were determined eligible and contacted about the study 101 declined (74 not interested; 20 unreachable; 7 could not be enrolled because at that time there was no space in the program). 252 were seen in the baseline visit and randomized.
Participant milestones
| Measure |
Promoting First Relationships® (PFR)
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
125
|
|
Overall Study
Infant 6 Months
|
122
|
122
|
|
Overall Study
Infant 12 Months
|
120
|
123
|
|
Overall Study
COMPLETED
|
120
|
123
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Each arm consisted of dyads of mother-infant pairs.
Baseline characteristics by cohort
| Measure |
Promoting First Relationships® (PFR)
n=127 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=125 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Mothers · <=18 years
|
0 Participants
n=127 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=125 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=252 Participants • Each arm consisted of dyads of mother-infant pairs.
|
|
Age, Categorical
Mothers · Between 18 and 65 years
|
127 Participants
n=127 Participants • Each arm consisted of dyads of mother-infant pairs.
|
125 Participants
n=125 Participants • Each arm consisted of dyads of mother-infant pairs.
|
252 Participants
n=252 Participants • Each arm consisted of dyads of mother-infant pairs.
|
|
Age, Categorical
Mothers · >=65 years
|
0 Participants
n=127 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=125 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=252 Participants • Each arm consisted of dyads of mother-infant pairs.
|
|
Age, Categorical
Infants · <=18 years
|
127 Participants
n=127 Participants • Each arm consisted of dyads of mother-infant pairs.
|
125 Participants
n=125 Participants • Each arm consisted of dyads of mother-infant pairs.
|
252 Participants
n=252 Participants • Each arm consisted of dyads of mother-infant pairs.
|
|
Age, Categorical
Infants · Between 18 and 65 years
|
0 Participants
n=127 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=125 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=252 Participants • Each arm consisted of dyads of mother-infant pairs.
|
|
Age, Categorical
Infants · >=65 years
|
0 Participants
n=127 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=125 Participants • Each arm consisted of dyads of mother-infant pairs.
|
0 Participants
n=252 Participants • Each arm consisted of dyads of mother-infant pairs.
|
|
Age, Continuous
Mother participants
|
28.8 years
STANDARD_DEVIATION 5.8 • n=127 Participants • The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm.
|
27.4 years
STANDARD_DEVIATION 5.6 • n=125 Participants • The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm.
|
28.07 years
STANDARD_DEVIATION 5.8 • n=252 Participants • The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm.
|
|
Age, Continuous
Infant participants
|
.15 years
STANDARD_DEVIATION .04 • n=127 Participants • The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm.
|
.15 years
STANDARD_DEVIATION .04 • n=125 Participants • The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm.
|
.15 years
STANDARD_DEVIATION .04 • n=252 Participants • The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm.
|
|
Sex: Female, Male
Sex: Mothers · Female
|
127 Participants
n=127 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
125 Participants
n=125 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
252 Participants
n=252 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
|
Sex: Female, Male
Sex: Mothers · Male
|
0 Participants
n=127 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
0 Participants
n=125 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
0 Participants
n=252 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
|
Sex: Female, Male
Sex: Infants · Female
|
56 Participants
n=127 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
64 Participants
n=125 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
120 Participants
n=252 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
|
Sex: Female, Male
Sex: Infants · Male
|
71 Participants
n=127 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
61 Participants
n=125 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
132 Participants
n=252 Participants • There were 504 study participants consisting of 252 mother-infant dyads.
|
|
Ethnicity (NIH/OMB)
mothers · Hispanic or Latino
|
62 Participants
n=127 Participants
|
57 Participants
n=125 Participants
|
119 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
mothers · Not Hispanic or Latino
|
65 Participants
n=127 Participants
|
68 Participants
n=125 Participants
|
133 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
mothers · Unknown or Not Reported
|
0 Participants
n=127 Participants
|
0 Participants
n=125 Participants
|
0 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
infants · Hispanic or Latino
|
68 Participants
n=127 Participants
|
66 Participants
n=125 Participants
|
134 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
infants · Not Hispanic or Latino
|
59 Participants
n=127 Participants
|
59 Participants
n=125 Participants
|
118 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
infants · Unknown or Not Reported
|
0 Participants
n=127 Participants
|
0 Participants
n=125 Participants
|
0 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · American Indian or Alaska Native
|
2 Participants
n=127 Participants
|
2 Participants
n=125 Participants
|
4 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · Asian
|
3 Participants
n=127 Participants
|
5 Participants
n=125 Participants
|
8 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=127 Participants
|
3 Participants
n=125 Participants
|
4 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · Black or African American
|
21 Participants
n=127 Participants
|
23 Participants
n=125 Participants
|
44 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · White
|
84 Participants
n=127 Participants
|
81 Participants
n=125 Participants
|
165 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · More than one race
|
16 Participants
n=127 Participants
|
10 Participants
n=125 Participants
|
26 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Mothers · Unknown or Not Reported
|
0 Participants
n=127 Participants
|
1 Participants
n=125 Participants
|
1 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · American Indian or Alaska Native
|
1 Participants
n=127 Participants
|
4 Participants
n=125 Participants
|
5 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · Asian
|
2 Participants
n=127 Participants
|
0 Participants
n=125 Participants
|
2 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=127 Participants
|
2 Participants
n=125 Participants
|
2 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · Black or African American
|
20 Participants
n=127 Participants
|
17 Participants
n=125 Participants
|
37 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · White
|
79 Participants
n=127 Participants
|
68 Participants
n=125 Participants
|
147 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · More than one race
|
25 Participants
n=127 Participants
|
33 Participants
n=125 Participants
|
58 Participants
n=252 Participants
|
|
Race (NIH/OMB)
Infants · Unknown or Not Reported
|
0 Participants
n=127 Participants
|
1 Participants
n=125 Participants
|
1 Participants
n=252 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=127 Participants
|
125 participants
n=125 Participants
|
252 participants
n=252 Participants
|
|
NCATS Parenting Sensitivity
|
35.13 units on a scale
STANDARD_DEVIATION 4.90 • n=125 Participants • Missing data
|
34.21 units on a scale
STANDARD_DEVIATION 5.13 • n=123 Participants • Missing data
|
34.63 units on a scale
STANDARD_DEVIATION 4.97 • n=248 Participants • Missing data
|
|
Sensitivity in Play-Dyadic Synchrony
|
4.58 units on a scale
STANDARD_DEVIATION 2.41 • n=126 Participants • Missing data
|
3.88 units on a scale
STANDARD_DEVIATION 2.13 • n=125 Participants • Missing data
|
4.26 units on a scale
STANDARD_DEVIATION 2.32 • n=251 Participants • Missing data
|
|
Parent Understanding of Toddlers
|
51.17 units on a scale
STANDARD_DEVIATION 5.05 • n=127 Participants • Missing data
|
49.88 units on a scale
STANDARD_DEVIATION 4.98 • n=124 Participants • Missing data
|
50.66 units on a scale
STANDARD_DEVIATION 5.18 • n=251 Participants • Missing data
|
|
Maternal Confidence
|
4.23 units on a scale
STANDARD_DEVIATION .44 • n=127 Participants
|
4.19 units on a scale
STANDARD_DEVIATION .48 • n=125 Participants
|
4.21 units on a scale
STANDARD_DEVIATION .46 • n=252 Participants
|
|
Infant Interactive Quality-Difficultness
|
3.81 units on a scale
STANDARD_DEVIATION 3.26 • n=126 Participants • Missing data
|
4.12 units on a scale
STANDARD_DEVIATION 3.03 • n=125 Participants • Missing data
|
4.02 units on a scale
STANDARD_DEVIATION 3.13 • n=251 Participants • Missing data
|
PRIMARY outcome
Timeframe: Baseline to infant age 12 monthsNursing Child Assessment Teaching Scale: coded from observation of mother interacting with the infant during teaching task. The parenting sensitivity score can range from 0 to 50; higher scores indicate greater sensitivity.
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=113 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=112 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Change in Parent Sensitivity in Teaching
|
36.73 score on a scale
Standard Deviation 4.30
|
35.32 score on a scale
Standard Deviation 4.52
|
PRIMARY outcome
Timeframe: Baseline to infant age 12 monthsChild-Adult Relationship Experimental-Index (CARE-Index): coded from observation of mother and infant in free play activity. Dyadic synchrony and maternal sensitivity scores can range from 0 to 14, with higher scores indicating more positive interactions. \[Because maternal sensitivity and dyadic synchrony are correlated .98-.99, only dyadic synchrony will be reported.\]
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=113 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=112 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Change in Parent Sensitivity in Play
|
6.45 units on a scale
Standard Deviation 2.12
|
5.98 units on a scale
Standard Deviation 2.35
|
PRIMARY outcome
Timeframe: Baseline to infant age 12 monthsMaternal Confidence Questionnaire (MCQ; Zahr, 1991): 14-item self report measure rated on a 5-point frequency scale. The mean score can range from 1 to 5, with higher scores indicating greater maternal confidence.
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=120 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=123 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Change in Maternal Confidence
|
4.40 score on a scale
Standard Deviation .33
|
4.36 score on a scale
Standard Deviation .37
|
PRIMARY outcome
Timeframe: Baseline to infant age 12 monthsRaising a Baby Scale: 16-item self-report measure rated on a 4-point agree/disagree scale. The scores can range from 16 to 64, with higher scores indicating greater parental knowledge.
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=120 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=123 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Change in Parent Understanding of Toddlers
|
51.84 score on a scale
Standard Deviation 4.88
|
48.67 score on a scale
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Baseline to infant age 12 monthsCARE-Index: coded from observation of mother and infant in free play activity. Child cooperation scores can range from 0 to 14, with higher scores indicating more positive interactions. (Because child cooperation and dyadic synchrony are correlated .95-.96, a different CARE-Index scale with lower correlations with dyadic synchrony (-.32 to .05), child difficultness, will be used).
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=113 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=112 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Change in Infant Interactive Quality
|
2.23 units on a scale
Standard Deviation 2.02
|
2.71 units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: infant age 12 monthsInfant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems.
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=120 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=123 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Infant Behavioral Regulation: Externalizing T Score
|
59.24 score on a scale
Standard Deviation 11.06
|
62.54 score on a scale
Standard Deviation 12.37
|
SECONDARY outcome
Timeframe: infant age 12 monthsInfant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems.
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=120 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=123 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Infant Behavioral Regulation: Internalizing T Score
|
53.64 score on a scale
Standard Deviation 10.82
|
54.93 score on a scale
Standard Deviation 11.48
|
SECONDARY outcome
Timeframe: infant age 12 monthsInfant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems.
Outcome measures
| Measure |
Promoting First Relationships® (PFR)
n=120 Participants
10 week home visiting program
Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting.
|
Parent Information Packet
n=123 Participants
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
|---|---|---|
|
Infant Behavioral Regulation: Dysregulation T Score
|
54.82 score on a scale
Standard Deviation 13.62
|
55.33 score on a scale
Standard Deviation 13.66
|
Adverse Events
Promoting First Relationships® (PFR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent Information Packet
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
Carol Rhodes, Director of Sponsored Programs
University of Washington
Phone: 206 543-2139
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place