A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Resilience Enhancement Skills Training video-based family therapy |
Behavioral: Resilience Enhancement Skills Training
Family therapy
|
| Active Comparator: Standard of care video-based individual therapy |
Behavioral: Problem-Solving Individual Therapy
Individual therapy
|
Outcome Measures
Primary Outcome Measures
- Beck Depression Inventory-Second Edition [Change from baseline Beck Depression Inventory-Second Edition score at 6 months]
Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms).
- Perceived Hostility Survey (Ages 18 + and Ages 8-17) [Change from baseline Perceived Hostility Survey score at 6 months]
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).
- Multidimensional Scale of Perceived Social Support - Family subscale [Change from baseline Multidimensional Scale of Perceived Social Support-Family subscale score at 6 months]
Family cohesion. The Multidimensional Scale of Perceived Social Support-Family subscale scores range from 7-28, and higher scores indicate greater cohesion.
- Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version, and Children and Adolescents version) [Change from baseline Emotion Regulation Questionnaire-Cognitive Reappraisal scale score at 6 months]
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).
Secondary Outcome Measures
- Maternal school enrollment/job attainment [Change from baseline maternal school enrollment/job attainment at 6 months]
functional outcome
Eligibility Criteria
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
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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;
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Mothers with bipolar disorder symptoms;
-
Psychotic symptoms in the mother and/or her family member;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Hitchcock Clinic | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Fallon Cluxton-Keller, Ph.D., Dartmouth-Hitchcock Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D21065
- 1R34MH124951