Back to resultsA Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Primary Purpose
Perinatal Depression, Postpartum Depression, Family Conflict
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilience Enhancement Skills Training
Problem-Solving Individual Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Perinatal Depression
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.
Sites / Locations
- Dartmouth-Hitchcock Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resilience Enhancement Skills Training
Standard of care
Arm Description
video-based family therapy
video-based individual therapy
Outcomes
Primary Outcome Measures
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).
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).
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.
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).
Secondary Outcome Measures
Maternal school enrollment/job attainment
functional outcome
Full Information
NCT ID
NCT04741776
First Posted
February 2, 2021
Last Updated
July 14, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04741776
Brief Title
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Official Title
A Pilot Randomized Trial of Video-based Family Therapy for Home Visited Mothers With Perinatal Depressive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Postpartum Depression, Family Conflict
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resilience Enhancement Skills Training
Arm Type
Experimental
Arm Description
video-based family therapy
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
video-based individual therapy
Intervention Type
Behavioral
Intervention Name(s)
Resilience Enhancement Skills Training
Intervention Description
Family therapy
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Individual Therapy
Intervention Description
Individual therapy
Primary Outcome Measure Information:
Title
Beck Depression Inventory-Second Edition
Description
Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms).
Time Frame
Change from baseline Beck Depression Inventory-Second Edition score at 6 months
Title
Perceived Hostility Survey (Ages 18 + and Ages 8-17)
Description
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).
Time Frame
Change from baseline Perceived Hostility Survey score at 6 months
Title
Multidimensional Scale of Perceived Social Support - Family subscale
Description
Family cohesion. The Multidimensional Scale of Perceived Social Support-Family subscale scores range from 7-28, and higher scores indicate greater cohesion.
Time Frame
Change from baseline Multidimensional Scale of Perceived Social Support-Family subscale score at 6 months
Title
Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version, and Children and Adolescents version)
Description
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).
Time Frame
Change from baseline Emotion Regulation Questionnaire-Cognitive Reappraisal scale score at 6 months
Secondary Outcome Measure Information:
Title
Maternal school enrollment/job attainment
Description
functional outcome
Time Frame
Change from baseline maternal school enrollment/job attainment at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fallon Cluxton-Keller, Ph.D.
Organizational Affiliation
Dartmouth-Hitchcock Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Clinic
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36194458
Citation
Cluxton-Keller F, Hegel MT. A Video-Delivered Family Therapeutic Intervention for Perinatal Women With Clinically Significant Depressive Symptoms and Family Conflict: Indicators of Feasibility and Acceptability. JMIR Form Res. 2022 Oct 4;6(10):e41697. doi: 10.2196/41697.
Results Reference
derived
Learn more about this trial
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
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