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NCT01326182 · ClinicalTrials.gov registry record · Phase 2

Intervention for Depressed Latina Mothers of Children With Asthma

A Phase 2 study of Pediatric Asthma and Maternal Depression, sponsored by Rhode Island Hospital.

Completed
Registry status
Phase 2
Development phase
114
Enrollment target
2
Study locations

NCT01326182: Completed Phase 2 study of Pediatric Asthma and Maternal Depression, sponsored by Rhode Island Hospital.

NCT01326182 is a Phase 2 study of Pediatric Asthma and Maternal Depression that has completed, run by Rhode Island Hospital. The registered enrollment target is 114 participants, below the 7,703-participant average among 9 other Pediatric Asthma trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01326182, a Phase 2 study of Pediatric Asthma and Maternal Depression, has completed, sponsored by Rhode Island Hospital.

COMPLETED
Registry status
Phase 2
Development phase
114 participants
Enrollment target
2
Study locations

Study 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. C

Primary Outcome

Changes in Asthma Control from baseline will be assessed using the ACT at End of Treatment and 4 months post treatment

Interventions

  • BEHAVIORAL MAADRE
  • BEHAVIORAL MAAS

Study Locations (2)

Rhode Island

  • Rhode Island Hospital - Providence

Other

  • University of Puerto Rico - Rio Piedras

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2009-08
Est. Completion 2012-12
Phase Phase 2
Rhode Island Hospital

130 total trials

What the finished NCT01326182 record still lists

NCT01326182 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 7,703-participant average among 9 other Pediatric Asthma trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Pediatric Asthma appearing as the primary indexed condition, and to 2 interventions - of which MAADRE is the first listed.

NCT01326182 reports a single indexed study location in Rhode Island, Other.

Frequently Asked Questions

What is clinical trial NCT01326182 about?

NCT01326182 is a clinical study titled "Intervention for Depressed Latina Mothers of Children With Asthma". 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 comb...

What is the current status of trial NCT01326182?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2009-08. Estimated completion is 2012-12.

What conditions does trial NCT01326182 study?

This clinical trial studies the following conditions: Pediatric Asthma, Maternal Depression.

What interventions are being tested in trial NCT01326182?

The interventions under investigation include: MAADRE (BEHAVIORAL), MAAS (BEHAVIORAL).

Who is sponsoring clinical trial NCT01326182?

This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01326182 being conducted?

This trial has 2 study locations across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pediatric Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01326182's enrollment target sits among peer trials

114 5th of 9 higher than 5 of 9 other Pediatric Asthma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pediatric Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01326182, the US trial registry maintained by the National Library of Medicine. NCT01326182 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.