Intervention for Depressed Latina Mothers of Children With Asthma (MAADRE)
Recruitment status was: Recruiting
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. Children 7-12 are included only for the assessment of asthma symptoms and lung function, which occurs at baseline, end of treatment, and 4-month follow up for 2 weeks at each time point. Participation in Phase 2 is expected to take approximately 6 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intervention for Depressed Latina Mothers of Children With Asthma|
- Asthma Control [ Time Frame: 2 months after baseline (end of treatment), 4 months post treatment ] [ Designated as safety issue: No ]Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment
- Maternal Depression [ Time Frame: 2 months after baseline (end of treatment), 4 months post treatment ] [ Designated as safety issue: No ]Changes in Maternal Depressive Symptoms from baseline will be evaluated using the Beck Depression Inventory at end of treatment and 4 months post treatment.
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms
Group-based intervention combining asthma education and CBT for depressive symptoms
Active Comparator: MAAS
Group-based treatment combining asthma education and general information regarding child health
Group-based intervention including asthma education and education regarding general child health
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326182
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|University of Puerto Rico|
|Rio Piedras, Puerto Rico|
|Principal Investigator:||Elizabeth L McQuaid, PhD||Rhode Island Hospital|