ParentingNCT02724774
Collaborative Perinatal Mental Health and Parenting Support in Primary Care
A study testing Promoting First Relationships® in people with Parenting and Mother-child Relations, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parenting, Mother-child Relations
- What is being tested?
- Promoting First Relationships®
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2015to 4 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently experiencing an acute crisis (e.g., severe domestic violence, homelessness, hospitalization, imprisonment)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-7920
About this study
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.
Read the 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.
- Conditions
- Parenting, Mother-child Relations
- Being tested
- Promoting First Relationships®
- Keywords
- infants, mental health, postpartum period
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting First Relationships®Behavioural
Also called PFR
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 group | Role | What they receive |
|---|---|---|
| Promoting First Relationships® (PFR) | Experimental | 10 week home visiting program Receives: Behavioral: Promoting First Relationships® |
| Parent Information Packet | No intervention | A packet is mailed to the families, including handouts related to child development, health, and local resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Sensitivity in Teaching
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.
Measured: Baseline to infant age 12 months
Change in Parent Sensitivity in Play
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.]
Measured: Baseline to infant age 12 months
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.
Measured: Baseline to infant age 12 months
Change in Parent Understanding of Toddlers
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.
Measured: Baseline to infant age 12 months
Secondary outcomes (4)
Change in Infant Interactive Quality
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).
Measured: Baseline to infant age 12 months
Infant Behavioral Regulation: Externalizing T Score
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.
Measured: infant age 12 months
Infant Behavioral Regulation: Internalizing T Score
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.
Measured: infant age 12 months
Infant Behavioral Regulation: Dysregulation T Score
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.
Measured: infant age 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start24 Nov 2015
- Primary completion4 Apr 2020
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Susan Spieker, University of Washington
- Investigators
- Susan J Spieker, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724774
- Sponsor's protocol ID
- STUDY00010114
- Other IDs
- R01HD080851
- Status last verified
- Nov 2021
- First submitted
- 15 Mar 2016
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 1891613Crittenden, 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.
PubMed 14561058Oxford 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.
PubMed 34591567Hash JB, Nelson DC, Fleming CB, Oxford ML, Lohr MJ, de Castro AB, Bleil ME, Spieker SJ. Expanded adverse childhood experiences and postpartum mental health among an under-resourced sample of Spanish- and English-speaking mothers referred for community-based mental health services during pregnancy. BMC Pregnancy Childbirth. 2026 Jun 13. doi: 10.1186/s12884-026-09401-w. Online ahead of print.
PubMed 42288803Hash JB, Oxford ML, Nelson DC, Lohr MJ, Fleming CB, de Castro AB, Spieker SJ. Efficacy of Promoting First Relationships(R) for English and Spanish Speakers: A Randomized Controlled Trial. J Fam Stud. 2025 May;34(5):1135-1150. doi: 10.1007/s10826-024-03003-w. Epub 2025 May 7.
PubMed 42017170
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Perinatal Mental Health and Parenting Support in Primary Care
- ClinicalTrials.gov ID
- NCT02724774
- Acronym / sponsor ID
- STUDY00010114
- Conditions
- Parenting, Mother-child Relations
- Keywords
- infants, mental health, postpartum period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promoting First Relationships® (PFR) | Experimental | Behavioral: Promoting First Relationships®10 week home visiting program |
| Parent Information Packet | No intervention | –A packet is mailed to the families, including handouts related to child development, health, and local resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Currently experiencing an acute crisis (e.g., severe domestic violence, homelessness, hospitalization, imprisonment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting First Relationships®Also: PFRPFR 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. | Behavioural | Promoting First Relationships® (PFR) |
Primary outcome
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.
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.]
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.
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.
4 secondary outcomes
Change in Infant Interactive Quality
Time frame: Baseline to infant age 12 months
Infant Behavioral Regulation: Externalizing T Score
Time frame: infant age 12 months
Infant Behavioral Regulation: Internalizing T Score
Time frame: infant age 12 months
Infant Behavioral Regulation: Dysregulation T Score
Time frame: infant age 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBarnard, 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.
- BackgroundKelly, J., & Korfmacher, J. (2008). Raising a baby. University of Washington NCAST Publications.
- BackgroundKelly, 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.
- Background: PubMed 1891613Zahr 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.
- BackgroundCrittenden, P. M. (1979-2010). CARE-Index: Infant Coding Manual. Family Relations Institute.
- Background: PubMed 14561058Carter 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.
- Results publication: PubMed 34591567Oxford 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.
- Derived from this study: PubMed 42288803Hash JB, Nelson DC, Fleming CB, Oxford ML, Lohr MJ, de Castro AB, Bleil ME, Spieker SJ. Expanded adverse childhood experiences and postpartum mental health among an under-resourced sample of Spanish- and English-speaking mothers referred for community-based mental health services during pregnancy. BMC Pregnancy Childbirth. 2026 Jun 13. doi: 10.1186/s12884-026-09401-w. Online ahead of print.
- Derived from this study: PubMed 42017170Hash JB, Oxford ML, Nelson DC, Lohr MJ, Fleming CB, de Castro AB, Spieker SJ. Efficacy of Promoting First Relationships(R) for English and Spanish Speakers: A Randomized Controlled Trial. J Fam Stud. 2025 May;34(5):1135-1150. doi: 10.1007/s10826-024-03003-w. Epub 2025 May 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Spieker, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting First Relationships® in people with Parenting and Mother-child Relations, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Sensitivity in Teaching (time frame: Baseline to infant age 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724774, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.