CompletedNot Applicable

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

United States166 participantsStarted 2021-04-22

Plain-language summary

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.

Who can participate

Age range15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up

Timeframe: Baseline and six month follow-up

Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up

Timeframe: baseline and six month follow-up

Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up

Timeframe: baseline and six month follow-up

Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up

Timeframe: Baseline and six month follow-up

Trial details

NCT IDNCT04741776

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

Results submitted2024-11-07

View on ClinicalTrials.gov More Perinatal Depression trials

Plain-language summary

Who can participate

Age range15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up

Timeframe: Baseline and six month follow-up

Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up

Timeframe: baseline and six month follow-up

Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up

Timeframe: baseline and six month follow-up

Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up

Timeframe: Baseline and six month follow-up