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Clinical Trials/NCT04741776
NCT04741776
Completed
Not Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country166 target enrollmentApril 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perinatal Depression
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
166
Locations
1
Primary Endpoint
Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2021
End Date
November 14, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fallon P. Cluxton-Keller

Principal Investigator

Dartmouth-Hitchcock Medical Center

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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline and 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.

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

Time Frame: baseline and 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.

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

Time Frame: baseline and 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.

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

Time Frame: Baseline and 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).

Secondary Outcomes

  • Maternal School Enrollment/Job Attainment(Change from baseline in maternal school enrollment/job attainment at 6 months)

Study Sites (1)

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