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MAADRE for Asthma (MAADRE Trial)

Phase 2
Waitlist Available
Led By Elizabeth L McQuaid, PhD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months after baseline (end of treatment), 4 months post treatment
Awards & highlights

MAADRE 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.

Eligible Conditions
  • Asthma
  • Postpartum Depression

MAADRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months after baseline (end of treatment), 4 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months after baseline (end of treatment), 4 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma Control
Secondary outcome measures
Maternal Depression

MAADRE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MAADREExperimental Treatment1 Intervention
Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms
Group II: MAASActive Control1 Intervention
Group-based treatment combining asthma education and general information regarding child health
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAADRE
2009
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
66,893 Total Patients Enrolled
10 Trials studying Asthma
3,500 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,010 Total Patients Enrolled
277 Trials studying Asthma
112,557 Patients Enrolled for Asthma
Elizabeth L McQuaid, PhDPrincipal InvestigatorRhode Island Hospital
1 Previous Clinical Trials
432 Total Patients Enrolled
1 Trials studying Asthma
432 Patients Enrolled for Asthma

Frequently Asked Questions

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~7 spots leftby Apr 2025