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Active, Not Recruiting

NCT Number: NCT05345834

The DC Mother-Infant Behavioral Wellness Program

This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Perinatal Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Perinatal Anxiety Pregnancy Complications Prenatal Stress Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unity Healthcare - Brentwood

Washington D.C., District of Columbia, 20018, United States

About this study

The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-income Black/of African descent women with pregnancy-related stress, anxiety, and depression. There are two specific aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) intervention for low-income Black/of African Descent women designed to increase recruitment and retention within the healthcare community system, and (2) through a two-arm prospective randomized controlled design, women who are subthreshold and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) existing prenatal intervention (usual care); or (b) patient navigation plus culturally adapted CBT, and peer support groups.

The investigators will screen 1,000 low-income pregnant AA women (18-45 years of age) in their second pregnancy visit with validated tools for stress, anxiety, and depression. A total of 700 study participants will be recruited from urban prenatal care centers in the Washington DC area and will be randomized Usual Care of Intervention conditions above (n=350/condition). Following randomization, participants will participate in a diagnostic interview based on DSM-5 criteria to 'self-select' themselves into 1 of 2 groups (i.e., 'threshold' or 'subthreshold'). Threshold includes women who meet criteria for depression or anxiety based on DSM-5 diagnostic criteria. Subthreshold includes all other women who do not meet DSM criteria). In the intervention arm, participants in the threshold group will receive a 1:1 CBT treatment intervention, and participants in the subthreshold group will receive a group CBT intervention. Both threshold groups will also include patient navigation and participation in a peer support group. Participants will complete standardized health, mental health, and well-being questionnaires during pregnancy at their prenatal site, and up to 12 months after delivery at their well-baby visits, when they also will complete questionnaires about their infants' development and behavior. All infants also will undergo a standardized developmental test at 12 months. Health care utilization and outcomes also will be collected through electronic medical records.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Black/of African Descent
  • Pregnant (gestational weeks ≤ 28 weeks)
  • Age 18-45
  • English proficient
  • Receiving services in 1 of 4 study sites above
  • Low-income: i.e., receiving Medicaid
  • Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety)
  • Able to provide consent

Exclusion criteria

  • age <18
  • Currently under the influence of a substance(s)
  • Experiencing psychosis
  • Critical (clinical) risk: actively suicidal or homicidal
  • Not Black/of African Descent
  • Planning to deliver outside DC

Treatment and study plan

Patient Navigation

Behavioral

Participants in arm 2 will receive patient navigation provided by humans (rather than e-navigation) to provide personalized care to include support, resources, and referrals to address psychosocial issues that arise during the perinatal period. Patient navigation is available to participants through 12 months postpartum.

Other names: Maternity Care Specialist

Adapted Cognitive-Behavioral Therapy

Behavioral

Participants who do not meet diagnostic criteria (Group 2a) will participate in a prevention group which includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Participants who meet diagnostic criteria (Group 2b) will participate in individual treatment which includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.

Other names: Adapted CBT

Primary outcomes

  1. Change in Stress at 24 weeks of pregnancy to 12 months postpartum

    Time frame: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months

    Perceived Stress Scale: A 10-item questionnaire to measure the self-reported level of stress in the respondents by assessing feelings and thoughts during the last month. Each item is scored from 0 (never) to 5 (very often) with a range of 0 to 40 for the total score of the scale. A higher level of stress is indicated by higher scores on this scale.

  2. Change in Depression at 24 weeks of pregnancy to 12 months postpartum

    Time frame: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

    Edinburgh Postnatal Depression Scale: A 10-item scale used to indicate whether a parent has symptoms that are common in women with depression during pregnancy and in the year following the birth of a child. Each item is scored from 0 (As much as I ever did) to 3 (Not at all) with a range of 0 to 30. Higher level of depression is indicated by a higher score on this scale.

  3. Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum

    Time frame: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

    General Anxiety Disorder-7 (GAD-7): A 7-item scale to measure levels of anxiety in respondents by assessing feelings and thoughts over the past 2 weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day) with a range of 0 to 21. Higher level of depression is indicated by a higher score on this scale.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • George Washington University
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2022
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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