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

Not Applicable

Completed

Conditions: Family Conflict
Postpartum Depression
Perinatal Depression

Interventions: Behavioral: Resilience Enhancement Skills Training
Behavioral: Problem-Solving Individual Therapy

Registration Number: NCT04741776

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 166

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resilience Enhancement Skills Training	Resilience Enhancement Skills Training	video-based family therapy
Standard of care	Problem-Solving Individual Therapy	video-based individual therapy

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up	Baseline and six month follow-up	Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Higher score indicates greater depressive symptoms.
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up	baseline and six month follow-up	Family conflict was measured using the Perceived Hostility Survey (Ages 18 +) and Perceived Hostility Survey (Ages 8-17). In both versions of the Perceived Hostility Survey, raw scores are converted to uncorrected T-scores. Scores one standard deviation or more below the mean (T ≤ 40) suggest low levels of perceived hostility and scores one standard deviation or more above the mean (T ≥ 60) suggest high levels of perceived hostility.
Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up	baseline and six month follow-up	Family cohesion was measured using the Multidimensional Scale of Perceived Social Support-Family with scores that range from 7-28. Higher scores indicate greater cohesion.
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up	Baseline and six month follow-up	Family cognitive reappraisal. Adult participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 42 (frequent use of cognitive reappraisal). Adolescent participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Children and Adolescents version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 30 (frequent use of cognitive reappraisal).