A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2023-11-14

Brief Summary

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Depressed mothers (pregnant and post-delivery) make up a significant portion of Maternal, Infant, and Early Childhood Home Visiting (MIECHV) clients. Home visited mothers often experience family conflict that precipitates or worsens their depressive symptoms. This study uses an effectiveness-implementation hybrid type 1 design with a pilot randomized trial to test the feasibility, acceptability, tolerability, safety, and preliminary effectiveness of an innovative family therapy intervention that uses technology to bypass barriers to increase access to treatment for this vulnerable population.

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Detailed Description

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Conditions

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Perinatal Depression Postpartum Depression Family Conflict

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Video-based family therapy

Resilience Enhancement Skills Training (REST)

Group Type EXPERIMENTAL

Resilience Enhancement Skills Training

Intervention Type BEHAVIORAL

Family therapy

Standard of care

Video-based Problem Solving individual Therapy (V-PST)

Group Type ACTIVE_COMPARATOR

Problem-Solving Individual Therapy

Intervention Type BEHAVIORAL

Individual therapy

Interventions

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Resilience Enhancement Skills Training

Family therapy

Intervention Type BEHAVIORAL

Problem-Solving Individual Therapy

Individual therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Mothers in any trimester of pregnancy through 18 months postpartum who are enrolled in home visiting at a participating agency;
* Fluent in English;
* Mother and her family member have at least an 8th grade education;
* Mothers with Beck Depression Inventory-Second Edition scores of at least 20;
* Perceived Hostility Survey-Adult raw scores of at least 16 for the adult mother and her adult family member; Perceived Hostility Survey-Child raw scores of at least 14 for the adolescent mother and her adolescent intimate partner; and
* Consistent internet access on their cell phones, tablets, or computer equipped with a microphone and camera.

Exclusion Criteria

* Suicidal ideation in the mother and/or her family member;
* Mothers with bipolar disorder symptoms;
* Psychotic symptoms in the mother and/or her family member;
* Mother is currently receiving individual therapy;
* Family is currently receiving family therapy;
* Mothers who have been taking an antidepressant for less than 2 months; and
* Families with domestic violence.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No