View Clinical Trial (Medical Research Study)
Intervention for Depressed Latina Mothers of Children With Asthma
| City: |
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Providence |
| State: |
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Rhode Island |
| Zip Code: |
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02903 |
| Conditions: |
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Pediatric Asthma - Maternal Depression |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01326182 |
| Primary Contact: |
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Principal Investigator
Elizabeth L McQuaid, PhD
Rhode Island Hospital
Elizabeth L McQuaid, PhD
Phone: 401-444-7573
Email: emcquaid@lifespan.org
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| Backup Contact: |
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Email: bjandasek@lifespan.org
Barbara N Jandasek, PhD
Phone: 401-444-8945
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| Location Contact: |
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Providence, Rhode Island 02903
United States
Elizabeth L McQuaid, PhD
Phone: 401-444-7573
Email: emcquaid@lifespan.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
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