AsthmaNCT00250588
Problem-Solving Skills Training to Improve Care for Children With Asthma
A study testing Problem solving skills training and Asthma care coordination in people with Asthma, run by RAND at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Problem solving skills training and Asthma care coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Family does not speak English or Spanish
- Child has other comorbid conditions that would affect care or outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital, San Diego
San Diego, California, 92123
About this study
Official title: Reducing Barriers to Care for Vulnerable Children With Asthma
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.
Read the detailed description
Brief description: This 4-year research project will develop and test culturally and linguistically appropriate brief interventions to reduce barriers to health care for vulnerable children with persistent asthma.
Background: The U.S. health system presents formidable challenges to the timely receipt of high quality care, especially for vulnerable children (e.g., those in families of color, lower SES, limited English ability). This population is at greatest risk for poor health outcomes. Children with asthma are an important vulnerable subgroup. Asthma, with an estimated prevalence of 6.9%, is the most common chronic condition in children. It is the most frequent reason for pediatric hospitalization and is a condition with documented disparities in care outcomes.
A promising strategy for overcoming the barriers to quality care that these children encounter is the use of care coordinators who educate parents and children, connect the family with needed resources, and coordinate care from different settings. Care coordination has been shown effective in improving receipt of appropriate asthma services and health outcomes for children with asthma. Despite this evidence, there is concern that the effects of care coordination may not be maintained once these services end. This is particularly important given financial pressures to reduce the length and intensity of such services. In order to maintain the gains achieved during care coordination, families need to be able to identify and overcome barriers to care for and by themselves. This can be achieved through the use of Problem Solving Therapy, a documented behavioral method for teaching families the skills they need to resolve daily problems and improve adherence to medical regimens for children with chronic health conditions.
Study Goals: The overall goal of this project is to improve the quality of care and health outcomes for vulnerable children with asthma. The specific aims of this two-phase project are:
- (Phase I) to adapt, in collaboration with community health workers and parents, existing materials to create two culturally and linguistically appropriate treatment manuals: a Care Coordination Treatment Manual that will standardize the delivery of culturally and linguistically appropriate home-based care coordination and asthma-specific education, and a Problem Solving Therapy Treatment Manual tailored to asthma that will include a detailed, step-by-step guide for implementing this approach to reduce barriers to care.
- (Phase II) to use the manuals developed in Phase I to perform a randomized controlled clinical trial to evaluate the effectiveness of two brief interventions involving Care Coordination and tailored Problem Solving Therapy (tPST) in improving and maintaining improvement in health care quality and health-related quality of life for children with asthma.
Evidence for the efficacy of tPST and the availability of culturally and linguistically appropriate treatment manuals should spur diffusion of this innovation to other practitioners and programs seeking evidence-based, optimal clinical management strategies.
Methodology:
Phase I. Existing materials for the Care Coordination and tPST manuals will be edited and/or rewritten to make them specific to asthma. Then both the manuals and the proposed interventions will be assessed for cultural acceptability though two series of parallel focus groups: one for parents of children with asthma, and the other for home visitors already providing care coordination for families of children with asthma. The revised educational materials will then be translated into Spanish.
Phase II. Children ages 2-12 years with persistent asthma and their families (n = 366) will be randomized into two brief interventions:
- tPST (six sessions) plus Care Coordination (six home visits over 3 months) versus a Wait List control group (usual care) to evaluate the intervention's effectiveness in improving outcomes 3 months after baseline.
- tPST versus Care Coordination and Wait List to evaluate the intervention's effectiveness in maintaining outcomes 9 months after baseline.
- Conditions
- Asthma
- Being tested
- Problem solving skills training, Asthma care coordination, Usual Care
- Keywords
- Asthma, Child, Problem-solving, Quality of Life, Barriers to Care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem solving skills trainingBehavioural
See description in Results
Asthma care coordinationBehavioural
See description in Results
Usual CareOther
Usual clinical care
| Study group | Role | What they receive |
|---|---|---|
| Problem solving + care coordination | Experimental | Problem solving skills training and asthma care coordination Receives: Behavioral: Problem solving skills training; Behavioral: Asthma care coordination; Other: Usual Care |
| Asthma care coordination | Experimental | Asthma care coordination Receives: Behavioral: Asthma care coordination; Other: Usual Care |
| Wait-list control | Active comparator | Usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).
Measured: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Asthma Symptoms
Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.
Measured: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startOct 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Seid, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250588
- Sponsor's protocol ID
- R40 MC 00331
- Status last verified
- Apr 2013
- First submitted
- 4 Nov 2005
- Last updated
- 3 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20061311Seid 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.
PubMed 18977978
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers to Care for Vulnerable Children With Asthma
- ClinicalTrials.gov ID
- NCT00250588
- Acronym / sponsor ID
- R40 MC 00331
- Conditions
- Asthma
- Keywords
- Asthma, Child, Problem-solving, Quality of Life, Barriers to Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 8 Nov 2005 (estimated)
- Results
- Posted 3 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brief description: This 4-year research project will develop and test culturally and linguistically appropriate brief interventions to reduce barriers to health care for vulnerable children with persistent asthma.
Background: The U.S. health system presents formidable challenges to the timely receipt of high quality care, especially for vulnerable children (e.g., those in families of color, lower SES, limited English ability). This population is at greatest risk for poor health outcomes. Children with asthma are an important vulnerable subgroup. Asthma, with an estimated prevalence of 6.9%, is the most common chronic condition in children. It is the most frequent reason for pediatric hospitalization and is a condition with documented disparities in care outcomes.
A promising strategy for overcoming the barriers to quality care that these children encounter is the use of care coordinators who educate parents and children, connect the family with needed resources, and coordinate care from different settings. Care coordination has been shown effective in improving receipt of appropriate asthma services and health outcomes for children with asthma. Despite this evidence, there is concern that the effects of care coordination may not be maintained once these services end. This is particularly important given financial pressures to reduce the length and intensity of such services. In order to maintain the gains achieved during care coordination, families need to be able to identify and overcome barriers to care for and by themselves. This can be achieved through the use of Problem Solving Therapy, a documented behavioral method for teaching families the skills they need to resolve daily problems and improve adherence to medical regimens for children with chronic health conditions.
Study Goals: The overall goal of this project is to improve the quality of care and health outcomes for vulnerable children with asthma. The specific aims of this two-phase project are:
- (Phase I) to adapt, in collaboration with community health workers and parents, existing materials to create two culturally and linguistically appropriate treatment manuals: a Care Coordination Treatment Manual that will standardize the delivery of culturally and linguistically appropriate home-based care coordination and asthma-specific education, and a Problem Solving Therapy Treatment Manual tailored to asthma that will include a detailed, step-by-step guide for implementing this approach to reduce barriers to care.
- (Phase II) to use the manuals developed in Phase I to perform a randomized controlled clinical trial to evaluate the effectiveness of two brief interventions involving Care Coordination and tailored Problem Solving Therapy (tPST) in improving and maintaining improvement in health care quality and health-related quality of life for children with asthma.
Evidence for the efficacy of tPST and the availability of culturally and linguistically appropriate treatment manuals should spur diffusion of this innovation to other practitioners and programs seeking evidence-based, optimal clinical management strategies.
Methodology:
Phase I. Existing materials for the Care Coordination and tPST manuals will be edited and/or rewritten to make them specific to asthma. Then both the manuals and the proposed interventions will be assessed for cultural acceptability though two series of parallel focus groups: one for parents of children with asthma, and the other for home visitors already providing care coordination for families of children with asthma. The revised educational materials will then be translated into Spanish.
Phase II. Children ages 2-12 years with persistent asthma and their families (n = 366) will be randomized into two brief interventions:
- tPST (six sessions) plus Care Coordination (six home visits over 3 months) versus a Wait List control group (usual care) to evaluate the intervention's effectiveness in improving outcomes 3 months after baseline.
- tPST versus Care Coordination and Wait List to evaluate the intervention's effectiveness in maintaining outcomes 9 months after baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Problem solving + care coordination | Experimental | Behavioral: Problem solving skills training, Behavioral: Asthma care coordination, Other: Usual CareProblem solving skills training and asthma care coordination |
| Asthma care coordination | Experimental | Behavioral: Asthma care coordination, Other: Usual CareAsthma care coordination |
| Wait-list control | Active comparator | Other: Usual CareUsual care |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Family does not speak English or Spanish
- Child has other comorbid conditions that would affect care or outcomes
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 |
|---|---|---|
| Problem solving skills trainingSee description in Results | Behavioural | Problem solving + care coordination |
| Asthma care coordinationSee description in Results | Behavioural | Asthma care coordination, Problem solving + care coordination |
| Usual CareUsual clinical care | Other | Asthma care coordination, Problem solving + care coordination, Wait-list control |
Primary outcome
Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)
Time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
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.
2 secondary outcomes
Counts of Patients With One or More Asthma-related Emergency Department Visits.
Time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Asthma Symptoms
Time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20061311Seid 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.
- Derived from this study: PubMed 18977978Seid 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.
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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.
Michael Seid, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem solving skills training and Asthma care coordination in people with Asthma, run by RAND at 1 site in United States.
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 3 inclusion and 2 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 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) (time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00250588, which also lists 2 linked publications.
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 3 Jun 2013.