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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripartum Depression
• Intervention / Treatment: Behavioral: family therapy

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Claremont, New Hampshire, United States, 03743
      • TLC Family Resource Center
    • Gorham, New Hampshire, United States, 03581
      • The Family Resource Center at Gorham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Home Visitor 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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Family therapy; Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.	Behavioral: family therapy; The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).
NO_INTERVENTION: Historical comparison group; The Edinburgh Postnatal Depression Scale scores of adolescent mothers in the intervention group will be compared to those of adolescent mothers, who were previously enrolled in the home visiting programs, at the same time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal depressive symptoms	Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)	5 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fallon P. Cluxton-Keller
• Collaborators: Dartmouth-Hitchcock Medical Center; National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Fallon P. Cluxton-Keller, Ph.D., Dartmouth College; Principal Investigator: Craig L. Donnelly, M.D., Dartmouth College; Study Chair: Martha L. Bruce, Ph.D., Dartmouth College

Publications and helpful links

General Publications

• Cluxton-Keller F, Donnelly CL, Williams M, Buteau J, Stolte P, Monroe-Cassel M, Bruce ML. An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial. Pilot Feasibility Stud. 2017 Nov 13;3:55. doi: 10.1186/s40814-017-0203-2. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2017
• Primary Completion (ACTUAL): June 13, 2018
• Study Completion (ACTUAL): June 13, 2018

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 29987; UL1TR001086 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No