N/A
N=166
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Perinatal Depression · Postpartum Depression · Family Conflict
Bottom Line
View on ClinicalTrials.gov: NCT04741776 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up — 28.3; 27.0; 6.9; 13.2 units on a scale (BDI-II)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resilience Enhancement Skills Training (Behavioral); Problem-Solving Individual Therapy (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up |
28.3; 27.0; 6.9; 13.2 | — |
| PRIMARY Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up |
58.7; 60.1; 60.1; 58.7; 44.2; 46.3 | — |
| PRIMARY Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up |
20.6; 20.9; 19.7; 20.2; 23.7; 24.0 | — |
| PRIMARY Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up |
23.5; 18.0; 28.1; 25.8; 31.6; 31.6 | — |
| SECONDARY Maternal School Enrollment/Job Attainment |
11; 12; 23; 13 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04741776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.