Skip to main content
OpenTrials
Completed

NCT Number: NCT03282448

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TLC Family Resource Center, Claremont, New Hampshire, United States

Loading trial locations.

About this study

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:

  • Explore the feasibility of integrating the treatment model into two Federal HV Program sites in New Hampshire.
  • Test the acceptability of the treatment model among depressed adolescent mothers and their families.
  • Explore preliminary impacts of the treatment on maternal depressive symptoms and parenting attitudes, family emotion regulation, and family functioning at two months post-intervention.

Who can participate

Healthy volunteers accepted: No

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

Home Visitor 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.

Family 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;
  • Current family therapy service involvement; and/or
  • Current or previous Dialectical Behavior Therapy (DBT) treatment.

Treatment and study plan

family therapy

Behavioral

The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).

Primary outcomes

  1. 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

  1. Therapist-family working alliance

    Time frame: 2.5 months

    Clinician rated, and maternal report and family member report.

  2. Family Satisfaction

    Time frame: 2.5 months

    Maternal report and family member report.

  3. Parenting attitudes

    Time frame: 5 months

    A reliable and valid self-report measure will be completed by mothers.

  4. Emotion regulation

    Time frame: 5 months

    A reliable and valid self-report measure will be completed by mothers and their family members.

  5. Family functioning

    Time frame: 5 months

    A reliable and valid self-report measure will be completed by mothers and their family members.

Sponsors and collaborators

Lead sponsor

Fallon P. Cluxton-Keller

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2017
Registry last updated
Jun 19, 2018

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.

Published trials that share one or more normalized conditions with this study.