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

Study Overview
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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.

Official Title
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A Pilot Randomized Trial of Video-based Family Therapy for Home Visited Mothers With Perinatal Depressive Symptoms

Conditions
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Perinatal Depression, Postpartum Depression, Family Conflict

Intervention / Treatment
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* Behavioral: Resilience Enhancement Skills Training
* Behavioral: Problem-Solving Individual Therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resilience Enhancement Skills Training<br>video-based family therapy | Behavioral: Resilience Enhancement Skills Training<br>* Family therapy<br>|
| Active Comparator: Standard of care<br>video-based individual therapy | Behavioral: Problem-Solving Individual Therapy<br>* Individual therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-Second Edition | Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). | Change from baseline Beck Depression Inventory-Second Edition score at 6 months | 
| Perceived Hostility Survey (Ages 18 + and Ages 8-17) | Family conflict. The Perceived Hostility Survey (Ages 18 +) raw scores range from 8 (low hostility) to 40 (high hostility). The Perceived Hostility Survey (Ages 8-17) raw scores range from 5 (low hostility) to 25 (high hostility). | Change from baseline Perceived Hostility Survey score at 6 months | 
| Multidimensional Scale of Perceived Social Support - Family subscale | Family cohesion. The Multidimensional Scale of Perceived Social Support-Family subscale scores range from 7-28, and higher scores indicate greater cohesion. | Change from baseline Multidimensional Scale of Perceived Social Support-Family subscale score at 6 months | 
| Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version, and Children and Adolescents version) | Family cognitive reappraisal. The Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version) scores range from 6 (infrequent use of cognitive reappraisal) to 42 (frequent use of cognitive reappraisal). The Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Children and Adolescents version) scores range from 6 (infrequent use of cognitive reappraisal) to 30 (frequent use of cognitive reappraisal). | Change from baseline Emotion Regulation Questionnaire-Cognitive Reappraisal scale score at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal school enrollment/job attainment | functional outcome | Change from baseline maternal school enrollment/job attainment at 6 months |