NCT01326182

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 18, 2023

Status Verified

July 1, 2010

Enrollment Period

2.3 years

First QC Date

July 8, 2010

Last Update Submit

November 14, 2023

Conditions

Pediatric AsthmaMaternal Depression

Keywords

asthmadepressionLatino

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maternal Depression

    2 months after baseline (end of treatment), 4 months post treatment

Study Arms (2)

MAADRE

EXPERIMENTAL

Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms

Behavioral: MAADRE

MAAS

ACTIVE COMPARATOR

Group-based treatment combining asthma education and general information regarding child health

Behavioral: MAAS

Interventions

MAADREBEHAVIORAL

Group-based intervention combining asthma education and CBT for depressive symptoms

MAADRE
MAASBEHAVIORAL

Group-based intervention including asthma education and education regarding general child health

MAAS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Latina mothers with symptoms of depression and children with persistent asthma
  • Ages 7-12 years old

You may not qualify if:

  • serious suicidal risk
  • significant psychopathology (psychosis)
  • ethnicity other than Latino

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Puerto Rico

Rio Piedras, Puerto Rico

Location

MeSH Terms

Conditions

AsthmaDepression

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Elizabeth L McQuaid, PhD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2010

First Posted

March 30, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

November 18, 2023

Record last verified: 2010-07

Locations

US(1)PR(1)