A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers (NCT04741776) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
United States166 participantsStarted 2021-04-22
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up
Timeframe: baseline and six month follow-up
3
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
4
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up