Clinical trial NCT04741776: A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Official title: A Pilot Randomized Trial of Video-based Family Therapy for Home Visited Mothers With Perinatal Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Postpartum Depression
Family Conflict
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-02-05
Enrollment: 166
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
timeFrame: Baseline and six month follow-up
measure: Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up
timeFrame: baseline and six month follow-up
measure: Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up
timeFrame: baseline and six month follow-up
measure: Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up
timeFrame: Baseline and six month follow-up
Secondary outcomes:
measure: Maternal School Enrollment/Job Attainment
timeFrame: Change from baseline in maternal school enrollment/job attainment at 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Clinic
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Clinic
name: Fallon Cluxton-Keller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.