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

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression; Family Conflict; Perinatal Depression
• Intervention / Treatment: Behavioral: Resilience Enhancement Skills Training; Behavioral: Problem-Solving Individual Therapy

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fallon Cluxton-Keller, Ph.D.; Phone Number: 603-650-4724; Email: Fallon.P.Cluxton-Keller@dartmouth.edu

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Fallon Cluxton-Keller, Ph.D., Dartmouth-Hitchcock Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: D21065; 1R34MH124951 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No