Intervention for Depressed Latina Mothers of Children With Asthma (MAADRE)
Primary Purpose
Pediatric Asthma, Maternal Depression
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MAADRE
MAAS
Sponsored by

About this trial
This is an interventional treatment trial for Pediatric Asthma focused on measuring asthma, depression, Latino
Eligibility Criteria
Inclusion Criteria:
- Latina mothers with symptoms of depression and children with persistent asthma
- Ages 7-12 years old
Exclusion Criteria:
- serious suicidal risk
- significant psychopathology (psychosis)
- ethnicity other than Latino
Sites / Locations
- Rhode Island HospitalRecruiting
- University of Puerto RicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MAADRE
MAAS
Arm Description
Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms
Group-based treatment combining asthma education and general information regarding child health
Outcomes
Primary Outcome Measures
Asthma Control
Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment
Secondary Outcome Measures
Maternal Depression
Changes in Maternal Depressive Symptoms from baseline will be evaluated using the Beck Depression Inventory at end of treatment and 4 months post treatment.
Full Information
NCT ID
NCT01326182
First Posted
July 8, 2010
Last Updated
March 29, 2011
Sponsor
Rhode Island Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01326182
Brief Title
Intervention for Depressed Latina Mothers of Children With Asthma
Acronym
MAADRE
Official Title
Intervention for Depressed Latina Mothers of Children With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
Detailed Description
Pediatric asthma, the most common childhood chronic illness, remains a significant public health problem. Research indicates marked health care disparities in asthma, with Latino children at particular risk for poor health outcomes. Maternal depressive symptoms are also high among poor women who have children with asthma, and may compromise effective asthma management. The first AIM of this R21 application is to develop a manualized treatment to integrate asthma education with CBT strategies to reduce depressive symptoms among Latina mothers of children with persistent asthma. Such an intervention has the potential to improve asthma outcomes through increasing maternal knowledge and self-efficacy to manage asthma. During Year 1, Expert Consultants and an investigator team with expertise in asthma education, culturally tailored treatment, and CBT for Latinos will provide input into the development of the integrated intervention (MAADRE, for its acronym in Spanish). Focus groups will be conducted with our target population in Rhode Island and Puerto Rico to refine intervention content. Qualitative data analyses will be used to prioritize intervention targets and to identify contextual differences between Island and Mainland groups. The second AIM of this application is to conduct a small two-site pilot of the MAADRE intervention in Rhode Island and Puerto Rico. During Year 2, the investigators will test the intervention with depressed mothers of children with asthma (32 in Puerto Rico and 32 in Rhode Island.) Mothers will be randomly assigned to receive either the MAADRE intervention or asthma education + child health (control). The investigators expect that target children of participants in the MAADRE intervention will have improved asthma outcomes (asthma symptom days, lung function as measured by FEV1 and FEV1/FVC, asthma-related quality of life, and asthma control) relative to the control condition. The investigators also anticipate that participants in the MAADRE intervention will have greater reduction in depressive symptoms and improved self-efficacy to manage asthma relative to the control condition. Findings from the proposed application will be used to design a larger RCT to evaluate the effects of the MAADRE intervention on asthma outcomes, and to compare cost-effectiveness of the intervention approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Asthma, Maternal Depression
Keywords
asthma, depression, Latino
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MAADRE
Arm Type
Experimental
Arm Description
Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms
Arm Title
MAAS
Arm Type
Active Comparator
Arm Description
Group-based treatment combining asthma education and general information regarding child health
Intervention Type
Behavioral
Intervention Name(s)
MAADRE
Intervention Description
Group-based intervention combining asthma education and CBT for depressive symptoms
Intervention Type
Behavioral
Intervention Name(s)
MAAS
Intervention Description
Group-based intervention including asthma education and education regarding general child health
Primary Outcome Measure Information:
Title
Asthma Control
Description
Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment
Time Frame
2 months after baseline (end of treatment), 4 months post treatment
Secondary Outcome Measure Information:
Title
Maternal Depression
Description
Changes in Maternal Depressive Symptoms from baseline will be evaluated using the Beck Depression Inventory at end of treatment and 4 months post treatment.
Time Frame
2 months after baseline (end of treatment), 4 months post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Latina mothers with symptoms of depression and children with persistent asthma
Ages 7-12 years old
Exclusion Criteria:
serious suicidal risk
significant psychopathology (psychosis)
ethnicity other than Latino
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth L McQuaid, PhD
Phone
401-444-7573
Email
emcquaid@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara N Jandasek, PhD
Phone
401-444-8945
Email
bjandasek@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth L McQuaid, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth L McQuaid, PhD
Phone
401-444-7573
Email
emcquaid@lifespan.org
First Name & Middle Initial & Last Name & Degree
Barbara N Jandasek, PhD
Phone
401-444-8945
Email
bjandasek@lifespan.org
First Name & Middle Initial & Last Name & Degree
Elizabeth L McQuaid, PhD
Facility Name
University of Puerto Rico
City
Rio Piedras
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances M Colon, EdD
Phone
787-622-2888
Email
frances.colon4@upr.edu
First Name & Middle Initial & Last Name & Degree
Glorisa Canino, PhD
12. IPD Sharing Statement
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Intervention for Depressed Latina Mothers of Children With Asthma
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