NCT00241852

Brief Summary

The purpose of this study is to test two asthma management programs: (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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started May 2005

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

5.1 years

First QC Date

October 17, 2005

Last Update Submit

January 9, 2014

Conditions

AsthmaLung Diseases

Outcome Measures

Primary Outcomes (3)

  • Symptom severity

    baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

  • quality of life

    Baseline, and immediate, 6-months and 12-months post-intervention

  • asthma management skills

    Baseline, and immediate, 6-months and 12-months post-intervention

Secondary Outcomes (3)

  • Urgent health care utilization

    baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

  • days with activity restriction

    baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

  • parent-child interactions

    Baseline, and immediate, 6-months and 12-months post-intervention

Study Arms (2)

Behavioral Intervention: Asthma: It's a Family Affair

EXPERIMENTAL

Separate student and parent intervention groups.

Behavioral: Asthma: It's a Family Affair!

Behavioral Control Group

ACTIVE COMPARATOR

Students and parents participate in an education only control group

Behavioral: Asthma and Stress Comparator

Interventions

Asthma: It's a Family Affair!BEHAVIORAL

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.

Behavioral Intervention: Asthma: It's a Family Affair
Asthma and Stress ComparatorBEHAVIORAL

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.

Behavioral Control Group

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Child and participating parent must live together

You may not qualify if:

  • 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
  • Foster parents and their children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Bruzzese JM, Unikel L, Gallagher R, Evans D, Colland V. Feasibility and impact of a school-based intervention for families of urban adolescents with asthma: results from a randomized pilot trial. Fam Process. 2008 Mar;47(1):95-113. doi: 10.1111/j.1545-5300.2008.00241.x.

    PMID: 18411832BACKGROUND

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jean-Marie Bruzzese, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 19, 2005

Study Start

May 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)