Collaborative Perinatal Mental Health and Parenting Support in Primary Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724774

Enrollment

252

Registered

2016-03-31

Start date

2015-11-24

Completion date

2020-04-04

Last updated

2021-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother-child Relations, Parenting

Keywords

infants, mental health, postpartum period

Brief summary

Treating mothers' perinatal depressive and other mental health symptoms alone does not prevent impaired parenting quality and adverse infant outcomes. The goal of this research is to conduct a randomized controlled trial to evaluate the effectiveness of adding a research-based 10-week home visiting parenting program to evidence-based mental health treatment, to counter the pernicious effects of mothers' symptoms on parenting quality and infant development. Participants will be English and Spanish-speaking low-income mothers who began publicly funded mental/behavioral health treatment in pregnancy at their primary care community health centers.

Detailed description

Infants exposed to impaired parenting as a result of their mothers' major depression and other mental health disorders in the perinatal period are at risk for compromised social interaction and affective and behavioral regulation. Depression is the most frequently reported mental health condition during the perinatal period; about 9% of infants under one year have mothers who experience a major depressive episode. That rate nearly triples to 25% for infants of mothers below 200% of the federal poverty level. In addition to poverty, young maternal age, lack of social support, low education, and adverse childhood experiences are all risk factors for depression, anxiety, and other mental health conditions. Two strands of research point to the need for effective parenting support for mothers following treatment for mental health conditions in pregnancy. First, depressed mothers frequently fail to accurately notice, interpret, or respond sensitively to infant cues. Alarmingly, mothers' impaired parenting of their infants continues even after their depression has been successfully treated. Second, newborns of prenatally depressed women are physiologically dysregulated and hence more challenging to nurture. With the passage of the Affordable Care Act and Maternal, Infant, and Early Childhood Home Visiting, the federal government is supporting states to implement high-quality home visiting programs as part of a comprehensive early childhood system for vulnerable families experiencing the risk factors associated with maternal depression and other mental health symptoms. But two important limitations of home visiting have been identified: child development home visitors are not trained to deal meaningfully with maternal depression and other mental health conditions, and they are often not sufficiently trained to support infant-mother relationships. Our study has the potential to inform intervention programs nationwide by testing the effectiveness of adding a short, attachment-based, home-visiting parenting program to an existing, evidence-based mental health treatment program delivered via community primary care clinics serving pregnant and parenting women from vulnerable populations. The goal of this research is to conduct a randomized controlled trial to evaluate the effectiveness of Promoting First Relationships® for English and Spanish-speaking low-income mothers who were treated for depression or other mental health conditions beginning in pregnancy and as needed in the perinatal year. Treatment will be coordinated through the publicly funded, evidenced-based Mental Health Integration Program for High-Risk Pregnant and Parenting Women (MHIP Moms) in primary care community health centers that target safety-net populations in King County, Washington. Promoting First Relationships® is a research-based, 10-week home visiting program that uses video feedback and strengths-based consultation strategies to increase mothers' parenting competence and confidence. Bilingual community providers will deliver Promoting First Relationships® after a baseline assessment and random assignment at infant age three months. Post tests will occur at infant age six and twelve months. The primary specific aims are to test the effectiveness of PFR to improve parenting quality for low income, English and Spanish speaking mothers who began mental/behavioral health treatment during pregnancy, and to improve social and regulatory outcomes for their infants.

Interventions

BEHAVIORALPromoting 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Mothers with infants 6 weeks - 3 months old * English or Spanish speaking * Access to a telephone * Currently or at some point during pregnancy received treatment for a mental health condition (counseling and/or medications) at a participating community health center in the Seattle, Washington area

Exclusion criteria

* Currently experiencing an acute crisis (e.g., severe domestic violence, homelessness, hospitalization, imprisonment)

Design outcomes

Primary

Measure	Time frame	Description
Change in Parent Understanding of Toddlers	Baseline to infant age 12 months	Raising 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.
Change in Parent Sensitivity in Teaching	Baseline to infant age 12 months	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.
Change in Parent Sensitivity in Play	Baseline to infant age 12 months	Child-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. \[Because maternal sensitivity and dyadic synchrony are correlated .98-.99, only dyadic synchrony will be reported.\]
Change in Maternal Confidence	Baseline to infant age 12 months	Maternal 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.

Secondary

Measure	Time frame	Description
Change in Infant Interactive Quality	Baseline to infant age 12 months	CARE-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).
Infant Behavioral Regulation: Externalizing T Score	infant age 12 months	Infant 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.
Infant Behavioral Regulation: Internalizing T Score	infant age 12 months	Infant 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.
Infant Behavioral Regulation: Dysregulation T Score	infant age 12 months	Infant 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	127
Parent Information Packet A packet is mailed to the families, including handouts related to child development, health, and local resources.	125
Total	252

Baseline characteristics

Characteristic	Parent Information Packet	Total	Promoting First Relationships® (PFR)
Age, Categorical Infants <=18 years	125 Participants	252 Participants	127 Participants
Age, Categorical Infants >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Infants Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Mothers <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical Mothers >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Mothers Between 18 and 65 years	125 Participants	252 Participants	127 Participants
Age, Continuous Infant participants	.15 years STANDARD_DEVIATION 0.04	.15 years STANDARD_DEVIATION 0.04	.15 years STANDARD_DEVIATION 0.04
Age, Continuous Mother participants	27.4 years STANDARD_DEVIATION 5.6	28.07 years STANDARD_DEVIATION 5.8	28.8 years STANDARD_DEVIATION 5.8
Ethnicity (NIH/OMB) infants Hispanic or Latino	66 Participants	134 Participants	68 Participants
Ethnicity (NIH/OMB) infants Not Hispanic or Latino	59 Participants	118 Participants	59 Participants
Ethnicity (NIH/OMB) infants Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) mothers Hispanic or Latino	57 Participants	119 Participants	62 Participants
Ethnicity (NIH/OMB) mothers Not Hispanic or Latino	68 Participants	133 Participants	65 Participants
Ethnicity (NIH/OMB) mothers Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Infant Interactive Quality-Difficultness	4.12 units on a scale STANDARD_DEVIATION 3.03	4.02 units on a scale STANDARD_DEVIATION 3.13	3.81 units on a scale STANDARD_DEVIATION 3.26
Maternal Confidence	4.19 units on a scale STANDARD_DEVIATION 0.48	4.21 units on a scale STANDARD_DEVIATION 0.46	4.23 units on a scale STANDARD_DEVIATION 0.44
NCATS Parenting Sensitivity	34.21 units on a scale STANDARD_DEVIATION 5.13	34.63 units on a scale STANDARD_DEVIATION 4.97	35.13 units on a scale STANDARD_DEVIATION 4.9
Parent Understanding of Toddlers	49.88 units on a scale STANDARD_DEVIATION 4.98	50.66 units on a scale STANDARD_DEVIATION 5.18	51.17 units on a scale STANDARD_DEVIATION 5.05
Race (NIH/OMB) Infants American Indian or Alaska Native	4 Participants	5 Participants	1 Participants
Race (NIH/OMB) Infants Asian	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Infants Black or African American	17 Participants	37 Participants	20 Participants
Race (NIH/OMB) Infants More than one race	33 Participants	58 Participants	25 Participants
Race (NIH/OMB) Infants Native Hawaiian or Other Pacific Islander	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Infants Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Infants White	68 Participants	147 Participants	79 Participants
Race (NIH/OMB) Mothers American Indian or Alaska Native	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) Mothers Asian	5 Participants	8 Participants	3 Participants
Race (NIH/OMB) Mothers Black or African American	23 Participants	44 Participants	21 Participants
Race (NIH/OMB) Mothers More than one race	10 Participants	26 Participants	16 Participants
Race (NIH/OMB) Mothers Native Hawaiian or Other Pacific Islander	3 Participants	4 Participants	1 Participants
Race (NIH/OMB) Mothers Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Mothers White	81 Participants	165 Participants	84 Participants
Region of Enrollment United States	125 participants	252 participants	127 participants
Sensitivity in Play-Dyadic Synchrony	3.88 units on a scale STANDARD_DEVIATION 2.13	4.26 units on a scale STANDARD_DEVIATION 2.32	4.58 units on a scale STANDARD_DEVIATION 2.41
Sex: Female, Male Sex: Infants Female	64 Participants	120 Participants	56 Participants
Sex: Female, Male Sex: Infants Male	61 Participants	132 Participants	71 Participants
Sex: Female, Male Sex: Mothers Female	125 Participants	252 Participants	127 Participants
Sex: Female, Male Sex: Mothers Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 127	0 / 125
other Total, other adverse events	0 / 127	0 / 125
serious Total, serious adverse events	0 / 127	0 / 125

Outcome results

Primary

Change in Maternal Confidence

Maternal 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.