- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02724774
Collaborative Perinatal Mental Health and Parenting Support in Primary Care
November 17, 2021 updated by: Susan Spieker, University of Washington
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
252
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195-7920
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Promoting First Relationships® (PFR)
10 week home visiting program
|
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.
Other Names:
|
No Intervention: Parent Information Packet
A packet is mailed to the families, including handouts related to child development, health, and local resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parent Sensitivity in Teaching
Time Frame: 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.
|
Baseline to infant age 12 months
|
Change in Parent Sensitivity in Play
Time Frame: 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.]
|
Baseline to infant age 12 months
|
Change in Maternal Confidence
Time Frame: 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.
|
Baseline to infant age 12 months
|
Change in Parent Understanding of Toddlers
Time Frame: 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.
|
Baseline to infant age 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Infant Interactive Quality
Time Frame: 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).
|
Baseline to infant age 12 months
|
Infant Behavioral Regulation: Externalizing T Score
Time Frame: 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 age 12 months
|
Infant Behavioral Regulation: Internalizing T Score
Time Frame: 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 age 12 months
|
Infant Behavioral Regulation: Dysregulation T Score
Time Frame: 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 age 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan J Spieker, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barnard, K. E. (1994). What the Teaching Scale measures. In G. S. Sumner & A. Spietz (Eds.), NCAST: Caregiver/parent-child interaction teaching manual. University of Washington NCAST Publications.
- Kelly, J., & Korfmacher, J. (2008). Raising a baby. University of Washington NCAST Publications.
- Kelly, J., Sandoval, D., Zuckerman, T. G., & Buehlman, K. (2008). Promoting First Relationships: A program for service providers to help parents and other caregivers nurture young children's social and emotional development (2 ed.). University of Washington NCAST Programs.
- Zahr LK. The relationship between maternal confidence and mother-infant behaviors in premature infants. Res Nurs Health. 1991 Aug;14(4):279-86. doi: 10.1002/nur.4770140406.
- Crittenden, P. M. (1979-2010). CARE-Index: Infant Coding Manual. Family Relations Institute.
- Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.
- Oxford ML, Hash JB, Lohr MJ, Bleil ME, Fleming CB, Unutzer J, Spieker SJ. Randomized trial of promoting first relationships for new mothers who received community mental health services in pregnancy. Dev Psychol. 2021 Aug;57(8):1228-1241. doi: 10.1037/dev0001219.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 24, 2015
Primary Completion (Actual)
April 4, 2020
Study Completion (Actual)
April 4, 2020
Study Registration Dates
First Submitted
March 15, 2016
First Submitted That Met QC Criteria
March 24, 2016
First Posted (Estimate)
March 31, 2016
Study Record Updates
Last Update Posted (Actual)
December 15, 2021
Last Update Submitted That Met QC Criteria
November 17, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00010114
- R01HD080851 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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