Family Approach to Managing Asthma in Early Teens
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
BACKGROUND:
Asthma is a public health problem with its prevalence and morbidity being significant in 11- to 14-year olds, particularly among ethnic minorities. Despite this, little has been done to intervene with this age group. This is surprising considering the success of asthma education programs for younger children. In addition, there are no reports of parenting training to help families manage asthma despite the significant influence parenting strategies have on the management of chronic illnesses.
DESIGN NARRATIVE:
The overall goal of this study is to test the efficacy of a program with two complementary components: (a) a school-based curriculum to empower middle school students to manage their asthma and (b) a parent training curriculum to teach childrearing skills that support the youths' growing autonomy and need to self-manage their disease. The specific aims are: (1) to implement screening to identify 6th - 8th grade students with persistent asthma; and (2) to provide health education and parent training to help children and parents manage asthma more effectively. The student program is based on Coping with Asthma at Home and at School, a successful program developed in Holland. The parent program is an adaptation of Thriving Teens, an effective parent training program developed by the investigators. Participants in this randomized control trial will be 384 children with asthma and their caregivers from 16 New York City public schools serving low-income, ethnic minorities. It is hypothesized that students randomized to the intervention will have, relative to controls, improvements in three primary outcomes: (1) reduced symptom severity; (2) improved quality of life; and (3) better asthma management skills. Also, when compared to controls, intervention students will show improvement in the following secondary outcomes: (4) urgent health care utilization; (5) days with activity restriction; and (6) parent-child interactions. Caregivers and children will complete comprehensive surveys assessing these outcomes at baseline, and immediately and 6- and 12-months after the intervention.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10016
- New York University School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria for Youth:
- Prior diagnosis of asthma from a medical provider
- Asthma symptoms an average of 3 times per month during the 12 months prior to study entry OR less frequent symptoms but having 1 or more urgent visits to a doctor/emergency room or hospitalization for asthma during the 12 months prior to study entry
- Use of prescribed asthma medication in the 12 months prior to study entry
Inclusion Criteria for Families:
- Child and participating parent must live together
Exclusion Criteria for Youth:
- Co-morbidity that might affect lung function, such as cystic fibrosis or sickle cell anemia
- Highly specialized developmental or learning needs (e.g., Down's syndrome, mental retardation, severe ADHD)
- Major psychiatric illness
Exclusion Criteria for Families:
- Foster parents and their children
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Behavioral Intervention: Asthma: It's a Family Affair
Separate student and parent intervention groups.
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Intervention families will receive a comprehensive program with two complementary components: (1) a school-based intervention to empower middle school students to manage their asthma and (2) parent training to teach their caregivers childrearing skills that support the youth's growing autonomy and need to self-manage their disease.
The student component is comprised of 6, 60 minute group workshops; the caregiver component consists of 5, 90-minute group workshops.
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Comparatore attivo: Behavioral Control Group
Students and parents participate in an education only control group
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Caregivers assigned to the Asthma and Stress Comparator group will receive a single educational workshop focusing on the developmental changes adolescents experience, how these changes may cause stress, and ways to cope with stress.
The children will also participate in a single school-based session on similar topics.
Both caregivers and students will learn basic asthma facts.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Symptom severity
Lasso di tempo: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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quality of life
Lasso di tempo: Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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asthma management skills
Lasso di tempo: Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Urgent health care utilization
Lasso di tempo: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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days with activity restriction
Lasso di tempo: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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parent-child interactions
Lasso di tempo: Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jean-Marie Bruzzese, PhD, NYU Langone Health
Pubblicazioni e link utili
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 333 (Altro numero di sovvenzione/finanziamento: Florida Department of Health)
- R01HL079953 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .