Pediatric AsthmaPhase 2MAADRENCT01326182
Intervention for Depressed Latina Mothers of Children With Asthma
A Phase 2 study testing MAADRE and MAAS in people with Pediatric Asthma and Maternal Depression, run by Rhode Island Hospital at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pediatric Asthma, Maternal Depression
- What is being tested?
- MAADRE and MAAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Latina mothers with symptoms of depression and children with persistent asthma
- Ages 7-12 years old
Who cannot join
- serious suicidal risk
- significant psychopathology (psychosis)
- ethnicity other than Latino
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Pediatric Asthma, Maternal Depression
- Being tested
- MAADRE, MAAS
- Keywords
- asthma, depression, Latino
- Medical subject headings
- Asthma, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAADREBehavioural
Group-based intervention combining asthma education and CBT for depressive symptoms
MAASBehavioural
Group-based intervention including asthma education and education regarding general child health
| Study group | Role | What they receive |
|---|---|---|
| MAADRE | Experimental | Group-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms Receives: Behavioral: MAADRE |
| MAAS | Active comparator | Group-based treatment combining asthma education and general information regarding child health Receives: Behavioral: MAAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control
Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment
Measured: 2 months after baseline (end of treatment), 4 months post treatment
Secondary outcomes (1)
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.
Measured: 2 months after baseline (end of treatment), 4 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Elizabeth L McQuaid, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326182
- Sponsor's protocol ID
- 4040-09
- Other IDs
- R21HL095102-01A1
- Acronym
- MAADRE
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Depressed Latina Mothers of Children With Asthma
- ClinicalTrials.gov ID
- NCT01326182
- Acronym / sponsor ID
- MAADRE / 4040-09
- Conditions
- Pediatric Asthma, Maternal Depression
- Keywords
- asthma, depression, Latino
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAADRE | Experimental | Behavioral: MAADREGroup-based intervention combining asthma education and cognitive behavioral treatment for depressive symptoms |
| MAAS | Active comparator | Behavioral: MAASGroup-based treatment combining asthma education and general information regarding child health |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Latina mothers with symptoms of depression and children with persistent asthma
- Ages 7-12 years old
Key exclusion criteria (3 listed)
- serious suicidal risk
- significant psychopathology (psychosis)
- ethnicity other than Latino
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAADREGroup-based intervention combining asthma education and CBT for depressive symptoms | Behavioural | MAADRE |
| MAASGroup-based intervention including asthma education and education regarding general child health | Behavioural | MAAS |
Primary outcome
Asthma Control
Time frame: 2 months after baseline (end of treatment), 4 months post treatment
Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment
1 secondary outcome
Maternal Depression
Time frame: 2 months after baseline (end of treatment), 4 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth L McQuaid, PhD principal investigator
Rhode Island Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAADRE and MAAS in people with Pediatric Asthma and Maternal Depression, run by Rhode Island Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control (time frame: 2 months after baseline (end of treatment), 4 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.