NCT00250588

Brief Summary

The purpose of this study is to determine whether Problem-Solving Skills Training is effective in reducing barriers to health care and improving health-related quality of life for children with persistent asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable 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

October 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

June 3, 2013

Completed
Last Updated

June 3, 2013

Status Verified

April 1, 2013

Enrollment Period

4 years

First QC Date

November 4, 2005

Results QC Date

December 11, 2012

Last Update Submit

April 25, 2013

Conditions

Asthma

Keywords

AsthmaChildProblem-solvingQuality of LifeBarriers to Care

Outcome Measures

Primary Outcomes (1)

  • Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)

    The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, \& Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.

    Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)

Secondary Outcomes (2)

  • Counts of Patients With One or More Asthma-related Emergency Department Visits.

    Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)

  • Asthma Symptoms

    Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)

Study Arms (3)

Problem solving + care coordination

EXPERIMENTAL

Problem solving skills training and asthma care coordination

Behavioral: Problem solving skills trainingBehavioral: Asthma care coordinationOther: Usual Care

Asthma care coordination

EXPERIMENTAL

Asthma care coordination

Behavioral: Asthma care coordinationOther: Usual Care

Wait-list control

ACTIVE COMPARATOR

Usual care

Other: Usual Care

Interventions

Problem solving skills trainingBEHAVIORAL

See description in Results

Problem solving + care coordination
Asthma care coordinationBEHAVIORAL

See description in Results

Asthma care coordinationProblem solving + care coordination
Usual CareOTHER

Usual clinical care

Asthma care coordinationProblem solving + care coordinationWait-list control

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child age 2 to 12 years old, inclusive
  • Diagnosis of persistent asthma (mild, moderate, or severe) according to NHLBI criteria
  • Family speaks English or Spanish

You may not qualify if:

  • Family does not speak English or Spanish
  • Child has other comorbid conditions that would affect care or outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, San Diego

San Diego, California, 92123, United States

Location

Related Publications (2)

  • Seid M, Varni JW, Gidwani P, Gelhard LR, Slymen DJ. Problem-solving skills training for vulnerable families of children with persistent asthma: report of a randomized trial on health-related quality of life outcomes. J Pediatr Psychol. 2010 Nov;35(10):1133-43. doi: 10.1093/jpepsy/jsp133. Epub 2010 Jan 8.

    PMID: 20061311RESULT

  • Seid M. Barriers to care and primary care for vulnerable children with asthma. Pediatrics. 2008 Nov;122(5):994-1002. doi: 10.1542/peds.2007-3114.

    PMID: 18977978DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Substantial dropout, particularly from CC+PST, is a limitation. Our sample size was not large enough, nor was there sufficient variability in our secondary outcomes, to detect differences in health care utilization despite the odds ratios.

Results Point of Contact

Title
Michael Seid
Organization
CCHMC
michael.seid@cchmc.org
5138030083

Study Officials

  • Michael Seid, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 8, 2005

Study Start

October 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 3, 2013

Results First Posted

June 3, 2013

Record last verified: 2013-04

Locations

US(1)