Intervention for Depressed Latina Mothers of Children With Asthma (MAADRE)

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.

Study Overview

• Status: Completed
• Conditions: Maternal Depression; Pediatric Asthma
• Intervention / Treatment: Behavioral: MAADRE; Behavioral: MAAS

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Rio Piedras, Puerto Rico
    • University of Puerto Rico
• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAADRE; Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms	Behavioral: MAADRE; 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	Behavioral: MAAS; Group-based intervention including asthma education and education regarding general child health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control	Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment	2 months after baseline (end of treatment), 4 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months after baseline (end of treatment), 4 months post treatment

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Elizabeth L McQuaid, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimated): March 30, 2011

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: depression; asthma; Latino
• Additional Relevant MeSH Terms: Behavioral Symptoms; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Depression; Asthma
• Other Study ID Numbers: 4040-09; R21HL095102-01A1 (U.S. NIH Grant/Contract)