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

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741776
• Other study ID #: D21065
• Secondary ID: 1R34MH124951
• Status: Completed
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: November 14, 2023

Study information

• Verified date: December 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: November 14, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Family Conflict
• Perinatal Depression
• Postpartum Depression

Intervention

Behavioral:
• Resilience Enhancement Skills Training
Family therapy
• Problem-Solving Individual Therapy
Individual therapy

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Clinic	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Maternal school enrollment/job attainment	functional outcome	Change from baseline maternal school enrollment/job attainment at 6 months