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Completed

NCT Number: NCT04741776

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

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.

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Key information

Conditions

Perinatal Depression Depression, Postpartum Depressive Disorder Family Conflict Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resilience Enhancement Skills Training

Behavioral

Family therapy

Problem-Solving Individual Therapy

Behavioral

Individual therapy

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Maternal School Enrollment/Job Attainment

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

    Adapted item from ABCD study.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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