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Clinical Trials/NCT03282448
NCT03282448
Completed
N/A

Integrated Video-based Family Therapy for Peripartum Depression in Home Visited Mothers: A Pilot Study

Fallon P. Cluxton-Keller2 sites in 1 country26 target enrollmentMay 26, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripartum Depression
Sponsor
Fallon P. Cluxton-Keller
Enrollment
26
Locations
2
Primary Endpoint
Maternal depressive symptoms
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 26, 2017
End Date
June 13, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fallon P. Cluxton-Keller
Responsible Party
Sponsor Investigator
Principal Investigator

Fallon P. Cluxton-Keller

Assistant Professor Psychiatry

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

  • Willingness to participate in the study;
  • Intention to remain in current job for at least 12 months; and
  • Fluency in English: The training, treatment model, implementation meetings, and supervision sessions will be carried out in English.
  • Family Inclusion Criteria:
  • Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum;
  • Adolescent mothers with Edinburgh Postnatal Depression Scale scores of ≥8;
  • 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;
  • Fluency in English: The treatment will be carried out in English; and
  • 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.

Exclusion Criteria

  • Adolescent mothers with
  • A current positive screen for problem alcohol use on the CAGE or TWEAK;
  • A current positive screen on the drug abuse items on the home visiting interview;
  • A current positive screen for domestic violence on the Relationship Assessment Tool;
  • Current hallucinations and/or delusions;
  • Current homicidal ideation;
  • Current suicidal ideation;
  • 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
  • Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with
  • Current Child Protection Service involvement;

Outcomes

Primary Outcomes

Maternal depressive symptoms

Time Frame: 5 months

Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, \& Brown, 1996)

Secondary Outcomes

  • Family Satisfaction(2.5 months)
  • Parenting attitudes(5 months)
  • Therapist-family working alliance(2.5 months)
  • Emotion regulation(5 months)
  • Family functioning(5 months)

Study Sites (2)

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