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

NCT04741776 | Completed Results DMC

• 2 other identifiers: D210651R34MH124951
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Postpartum Depression; Family Conflict

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up

  Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Higher score indicates greater depressive symptoms.

  Baseline and six month follow-up

• Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up

  Family conflict was measured using the Perceived Hostility Survey (Ages 18 +) and Perceived Hostility Survey (Ages 8-17). In both versions of the Perceived Hostility Survey, raw scores are converted to uncorrected T-scores. Scores one standard deviation or more below the mean (T ≤ 40) suggest low levels of perceived hostility and scores one standard deviation or more above the mean (T ≥ 60) suggest high levels of perceived hostility.

  baseline and six month follow-up

• Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up

  Family cohesion was measured using the Multidimensional Scale of Perceived Social Support-Family with scores that range from 7-28. Higher scores indicate greater cohesion.

  baseline and six month follow-up

• Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up

  Family cognitive reappraisal. Adult participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 42 (frequent use of cognitive reappraisal). Adolescent participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Children and Adolescents version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 30 (frequent use of cognitive reappraisal).

  Baseline and six month follow-up

Secondary Outcomes (1)

• Maternal School Enrollment/Job Attainment

  Change from baseline in maternal school enrollment/job attainment at 6 months

Study Arms (2)

Video-based family therapy

EXPERIMENTAL

Resilience Enhancement Skills Training (REST)

Behavioral: Resilience Enhancement Skills Training

Standard of care

ACTIVE COMPARATOR

Video-based Problem Solving individual Therapy (V-PST)

Behavioral: Problem-Solving Individual Therapy

Interventions

Resilience Enhancement Skills Training BEHAVIORAL

Family therapy

Video-based family therapy

Problem-Solving Individual Therapy BEHAVIORAL

Individual therapy

Standard of care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (3)

• Cluxton-Keller F, Xie H, Hegel MT, Donnelly CL, Bruce ML. Preliminary Effectiveness of Family Therapy for Perinatal Depressive Symptoms: Results From a Pilot Randomized Trial. Fam Process. 2025 Jun;64(2):e70032. doi: 10.1111/famp.70032.

  PMID: 40159324 DERIVED

• Cluxton-Keller F, Hegel MT, Donnelly CL, Bruce ML. Video-Delivered Family Therapy for Perinatal Women With Depressive Symptoms and Family Conflict: Feasibility, Acceptability, Safety, and Tolerability Results From a Pilot Randomized Trial. JMIR Form Res. 2023 Nov 3;7:e51824. doi: 10.2196/51824.

  PMID: 37921846 DERIVED

• 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.

  PMID: 36194458 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Fallon Cluxton-Keller, Ph.D.
• Organization: Dartmouth-Hitchcock Clinic

Fallon.P.Cluxton-Keller@dartmouth.edu

603-650-4724

Study Officials

• Fallon Cluxton-Keller, Ph.D.

  Dartmouth-Hitchcock Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: April 22, 2021
• Primary Completion: June 1, 2023
• Study Completion: November 14, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Locations

US (1)