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NCT01326182 · ClinicalTrials.gov registry record · Phase 2
Intervention for Depressed Latina Mothers of Children With Asthma
A Phase 2 study of Pediatric Asthma and Maternal Depression, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 2
- Study locations
NCT01326182 is a Phase 2 study of Pediatric Asthma and Maternal Depression that has completed, run by Rhode Island Hospital. The registered enrollment target is 114 participants, below the 7,703-participant average among 9 other Pediatric Asthma trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01326182, a Phase 2 study of Pediatric Asthma and Maternal Depression, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is to develop and pilot test a new group-based intervention for depressed Latina mothers of children with asthma. The investigators ongoing work has identified that close to 50% of Latina mothers of children with asthma report significant symptoms of depression. The intervention will combine asthma education and cognitive-behavioral strategies (e.g., increasing the pleasant activities that you do to help your mood) to address symptoms of depression. The investigators hope to improve mothers' mood, their feelings of confidence that they can manage asthma, and children's level of asthma control. The project has two phases. In Phase 1, the investigators will develop the intervention by working on the treatment manual and then conducting focus groups with Latina mothers to get input on the intervention. The investigators expect 24 mothers at each of 2 sites (RI and PR) to participate in focus groups (8 mothers per group). The group will take approximately 1-1.5 hours. In Phase 2, the investigators will conduct a small pilot of the intervention at both sites with new participants. At each site, 4 groups (4 sessions each) will be run. Participants will have an equal chance of being placed in the new intervention condition (asthma education and mood management), or in a control condition that covers asthma education and general topics regarding child health and wellness (e.g., encouraging reading, reducing screen time, nutrition). Participants will participate in a baseline research session, in the 4 intervention group sessions, and then in two follow-up research sessions (one at end of treatment which is expected to occur two months after enrollment, and one at 4-months post-treatment). They will complete survey instruments that assess their own depressive symptoms, family demographic characteristics, access/barriers to health care, self-efficacy to manage asthma, social network support, and family climate, as well as their child's asthma symptom frequency. C
Conditions Studied
Interventions
- BEHAVIORAL MAADRE
- BEHAVIORAL MAAS
Study Locations (2)
Rhode Island
- Rhode Island Hospital - Providence
Other
- University of Puerto Rico - Rio Piedras
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01326182
The ClinicalTrials.gov registry entry for NCT01326182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,703-participant average among 9 other Pediatric Asthma trials with a reported enrollment target (99% lower). The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pediatric Asthma appearing as the primary indexed condition, and to 2 interventions - of which MAADRE is the first listed.
NCT01326182 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Rhode Island, Other.
Frequently Asked Questions
What is clinical trial NCT01326182 about?
NCT01326182 is a clinical study titled "Intervention for Depressed Latina Mothers of Children With Asthma". This study is to develop and pilot test a new group-based intervention for depressed Latina mothers of children with asthma. The investigators ongoing work has identified that close to 50% of Latina mothers of children with asthma report significant symptoms of depression. The intervention will comb...
What is the current status of trial NCT01326182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2009-08. Estimated completion is 2012-12.
What conditions does trial NCT01326182 study?
This clinical trial studies the following conditions: Pediatric Asthma, Maternal Depression.
What interventions are being tested in trial NCT01326182?
The interventions under investigation include: MAADRE (BEHAVIORAL), MAAS (BEHAVIORAL).
Who is sponsoring clinical trial NCT01326182?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01326182 being conducted?
This trial has 2 study locations across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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