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Completed

NCT Number: NCT05762133

African-American Social Support Effectiveness Treatment

The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. The African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) intervention will be delivered to fathers in an individual setting to target the context in which a mother lives to expand her support beyond the direct reach of her treatment professional. This study provides skills and training to fathers who have a partner with prenatal depression. The aim is to reduce maternal depression during the perinatal period and improve the family environment for the infant.

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Key information

Conditions

Maternal Perinatal Depression Anxiety Disorders Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

African-American (AA) mothers have a higher risk for perinatal depression than Caucasian women that is attributable to increased socio-environmental stressors. In addition, AA women have poor healthcare utilization and compliance with psychiatric treatment compared to Caucasian women. An intervention is required to supplement and support the clinical objectives of the mother's depression care without requiring the mother's direct involvement. Fathers are an underutilized resource to reduce the mother's environmental stress and encourage healthy maternal behaviors. The African-American Social Support Effectiveness Treatment- Partners alleviating Perinatal Depression (ASSET-PPD) protocol will target the fathers' support of the mothers' mental health treatment and their active engagement in the family to reduce maternal stress. The ASSET-PPD intervention will be designed to have 4 active modules that address key factors to reduce maternal stress during the prenatal period and 2 postpartum review sessions. The modules will be individual sessions constructed to provide training, information, and behavioral assignments to increase fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. ASSET-PPD will be evaluated in a pilot Randomized Clinical Trial (RCT) with 50 cohabitating or non-cohabitating fathers and AA mothers who will be randomized into the ASSET-PPD intervention or the comparator group. Fathers only will participate in the intervention, and mothers and fathers will complete measures of mental health and parental experiences. Maternal depressive symptoms will be assessed as a primary outcome, and breastfeeding and parent-infant interactions will be assessed as secondary outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Parents will be 18 years of age or older.
  • Parents are eligible for the study if the woman is in the 2nd trimester, she is receiving psychiatric treatment for depression with a score of 11 or greater on the Inventory of Depressive Symptoms-Self-Rated (IDS-SR16), which indicates clinically significant symptoms, and the mother is African-American
  • Parents do not need to be romantic partners to be eligible. Infants (0-6 months) are included in the study to examine the parent-infant interactions

Exclusion criteria

The parents will be excluded if:

  • There is report of ongoing physical or sexual abuse
  • They have plans to terminate the pregnancy
  • The woman is showing symptoms of hypomania/mania, psychosis, or substance use in the past 12 months

Father will be excluded if he:

  • Has symptoms of psychosis in the past 12 months
  • Has below 6th grade education
  • Has difficulty focusing on 1 hour of instruction

Treatment and study plan

African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)

Behavioral

This proposed novel intervention has four prenatal modules and two postpartum review sessions addressing key correlates of Perinatal Depression (PND) with the largest effect sizes by targeting fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. The intervention is based on the stress-generation and cognitive-behavior theories to frame skill-based individual sessions of didactics, interactive training, and trackable objectives.

Primary outcomes

  1. Maternal depression

    Time frame: Second trimester through six month postpartum

    The Inventory of Depressive Symptoms-Self-Rated (IDS-SR16) is a 16-item self-report measure of depressive symptoms. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome

  2. Maternal anxiety

    Time frame: Second trimester through six month postpartum

    The Generalized Anxiety Disorder-7-item (GAD-7) is a 7-item, self-report measure assesses the dimension of generalized anxiety. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome

Secondary outcomes

  1. Breastfeeding

    Time frame: Administered at 1-, 3-, and 6-months

    The FeedCat Tool (FT) is a 9-item self-report breastfeeding assessment that measures the type, amount, and mode of feeding. FT complies with the World Health Organization (WHO) and Centers for Disease Control (CDC) recommendations

  2. Infant affect and mood regulation

    Time frame: Administered at 1-, 3-, and 6-months

    The Infant Behavior Questionnaire- Revised (IBQ-R) is a 36-item parent-report measure of infant behaviors (positive/negative affect, regulation), Minimum value: 0, Maximum value: 7, Higher scores indicate greater level of temperament dimension of the 14 scales

  3. Parent-infant interaction quality

    Time frame: At 3- and 6-months

    Mothers and fathers will attend an onsite observation that includes a 5-minute free play with their infant separately and a 5-minute free play together as co-parents. Parent-infant interactions will be videotaped by a split-screen Noldus Media Recorder. Interaction quality will be coded on the Parent-Child Early Relational Assessment (PCERA). PCERA is a valid, reliable measure of the quality of affect and behavior in parent-child interactions and has been used in psychiatric studies and triadic interactions. Minimum value: 1, Maximum value: 5, Higher scores indicate better outcomes

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression

Acronym: ASSET-PPD

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2023
Registry last updated
Mar 3, 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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