Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01326182 |
| Other study ID # |
4040-09 |
| Secondary ID |
R21HL095102-01A1 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
August 2009 |
| Est. completion date |
December 2012 |
Study information
| Verified date |
July 2010 |
| Source |
Rhode Island Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
