Video-based Family Therapy for Peripartum Depression in Home Visited Mothers

Not Applicable

Completed

• Conditions: Peripartum Depression
• Interventions: Behavioral: family therapy

• Registration Number: NCT03282448
• Lead Sponsor: Fallon P. Cluxton-Keller

Brief Summary

This pilot study will explore the feasibility and acceptability of implementing a family-based treatment, using HIPAA-compliant video-based communication technology, for adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the context of home visiting.

Detailed Description

The purpose of the pilot study is to partner with two Federal Maternal, Infant and Early Childhood Home Visiting (HV) Program sites to implement a family-based treatment for depression, using HIPAA-compliant video-based communication technology, in adolescent mothers (pregnant and post-delivery). This implementation-effectiveness hybrid trial includes depressed adolescent mothers and their adult family members.

It has three aims:

1. Explore the feasibility of integrating the treatment model into two Federal HV Program sites in New Hampshire.

2. Test the acceptability of the treatment model among depressed adolescent mothers and their families.

3. Explore preliminary impacts of the treatment on maternal depressive symptoms and parenting attitudes, family emotion regulation, and family functioning at two months post-intervention.

Study Timeline

• Study Start: 2017-05-26
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Status Verified: 2018-06
• Primary Completion: 2018-06-13
• Study Completion: 2018-06-13
• Last Update Submitted: 2018-06-16
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Willingness to participate in the study;
2. Intention to remain in current job for at least 12 months; and
3. Fluency in English: The training, treatment model, implementation meetings, and supervision sessions will be carried out in English.

Family Inclusion Criteria:

1. Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum;
2. Adolescent mothers with Edinburgh Postnatal Depression Scale scores of ≥8;
3. At least one of the adolescent mother's family members ("family member" is defined as a person she is biologically related to, or significant close others/partners with whom she is not biologically related) must be willing and available to participate in eight of the 10 video-based family therapy sessions;
4. Fluency in English: The treatment will be carried out in English; and
5. Consistent internet access (i.e., subscribe to an internet service provider and do not experience weekly disruptions in service) on a cell phone, tablet, or computer equipped with a camera and microphone.

Family

Exclusion Criteria

Adolescent mothers with

1. A current positive screen for problem alcohol use on the CAGE or TWEAK;
2. A current positive screen on the drug abuse items on the home visiting interview;
3. A current positive screen for domestic violence on the Relationship Assessment Tool;
4. Current hallucinations and/or delusions;
5. Current homicidal ideation;
6. Current suicidal ideation;
7. Current severe major depressive episode as measured by the SCID-V Depression Module for those over age 18, or NIMH DISC-Y & DISC-P Mood Module for those under age 18; and/or
8. Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with
9. Current Child Protection Service involvement;
10. Current family therapy service involvement; and/or
11. Current or previous Dialectical Behavior Therapy (DBT) treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family therapy	family therapy	Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.

Primary Outcome Measures

Name	Time	Method
Maternal depressive symptoms	5 months	Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, \& Brown, 1996)

Secondary Outcome Measures

Name	Time	Method
Family functioning	5 months	A reliable and valid self-report measure will be completed by mothers and their family members.
Parenting attitudes	5 months	A reliable and valid self-report measure will be completed by mothers.
Therapist-family working alliance	2.5 months	Clinician rated, and maternal report and family member report.
Family Satisfaction	2.5 months	Maternal report and family member report.
Emotion regulation	5 months	A reliable and valid self-report measure will be completed by mothers and their family members.

Trial Locations

Locations (2)

TLC Family Resource Center; 🇺🇸 Claremont, New Hampshire, United States

The Family Resource Center at Gorham; 🇺🇸 Gorham, New Hampshire, United States