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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01326182
First received: July 8, 2010
Last updated: March 29, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Pediatric Asthma
Maternal Depression
Behavioral: MAADRE
Behavioral: MAAS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention for Depressed Latina Mothers of Children With Asthma

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Asthma Control [ Time Frame: 2 months after baseline (end of treatment), 4 months post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months after baseline (end of treatment), 4 months post treatment ] [ Designated as safety issue: No ]
    Changes in Maternal Depressive Symptoms from baseline will be evaluated using the Beck Depression Inventory at end of treatment and 4 months post treatment.


Estimated Enrollment: 64
Study Start Date: August 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326182

Contacts
Contact: Elizabeth L McQuaid, PhD 401-444-7573 emcquaid@lifespan.org
Contact: Barbara N Jandasek, PhD 401-444-8945 bjandasek@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Elizabeth L McQuaid, PhD    401-444-7573    emcquaid@lifespan.org   
Contact: Barbara N Jandasek, PhD    401-444-8945    bjandasek@lifespan.org   
Principal Investigator: Elizabeth L McQuaid, PhD         
Puerto Rico
University of Puerto Rico Recruiting
Rio Piedras, Puerto Rico
Contact: Frances M Colon, EdD    787-622-2888    frances.colon4@upr.edu   
Principal Investigator: Glorisa Canino, PhD         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Elizabeth L McQuaid, PhD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Elizabeth L. McQuaid, Prinicpal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01326182     History of Changes
Other Study ID Numbers: 4040-09, R21HL095102-01A1
Study First Received: July 8, 2010
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
asthma
depression
Latino

Additional relevant MeSH terms:
Asthma
Depression
Depressive Disorder
Behavioral Symptoms
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Mental Disorders
Mood Disorders
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014