Intervention for Depressed Latina Mothers of Children With Asthma (MAADRE)
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|ClinicalTrials.gov Identifier: NCT01326182|
Recruitment Status : Unknown
Verified July 2010 by Rhode Island Hospital.
Recruitment status was: Recruiting
First Posted : March 30, 2011
Last Update Posted : March 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Asthma Maternal Depression||Behavioral: MAADRE Behavioral: MAAS||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention for Depressed Latina Mothers of Children With Asthma|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
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
- Asthma Control [ Time Frame: 2 months after baseline (end of treatment), 4 months post treatment ]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 ]Changes in Maternal Depressive Symptoms from baseline will be evaluated using the Beck Depression Inventory at end of treatment and 4 months post treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326182
|Contact: Elizabeth L McQuaid, PhDemail@example.com|
|Contact: Barbara N Jandasek, PhDfirstname.lastname@example.org|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Elizabeth L McQuaid, PhD 401-444-7573 email@example.com|
|Contact: Barbara N Jandasek, PhD 401-444-8945 firstname.lastname@example.org|
|Principal Investigator: Elizabeth L McQuaid, PhD|
|University of Puerto Rico||Recruiting|
|Rio Piedras, Puerto Rico|
|Contact: Frances M Colon, EdD 787-622-2888 email@example.com|
|Principal Investigator: Glorisa Canino, PhD|
|Principal Investigator:||Elizabeth L McQuaid, PhD||Rhode Island Hospital|