Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03003286
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2016-11-21
Brief Title:
Community Based Intervention for Children With ADHD and ASD
Sponsor:
Lauren Kenworthy
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Community Based Intervention for Children With ADHD and ASD
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a new treatment Unstuck and On Target UOT works better worse or the same as the best treatment that is available now Contingency Behavioral Management CBM for low income children with Autism Spectrum Disorder ASD or Attention Deficit Hyperactivity Disorder ADHD
Detailed Description:
This project will compare the effectiveness of an innovative community-based cognitive-behavioral Executive Functioning EF treatment Unstuck and On Target UOT to the current standard of care a Contingency Behavioral Management CBM program in typically underserved children with ASD or ADHD Minimizing the impact of EF deficits in these pediatric disorders has broad public health implications providing the opportunity for improvement in the real-world long-term outcomes that stakeholders have told the investigators are most important to them more educational and vocational success more functional independence and improved Activities of Daily Living skills and better physical health with reduced morbidity and mortality The health disparity that this project addresses is the poorer outcomes and limited treatment choices associated with being a child from a low-income family who also has ADHD or ASD The research questions are
1 Which works better for low-income children with ASD UOT or CBM Researchers will test the comparative effectiveness of UOT to CBM treatments with low-income children with ASD
2 Which works better for low-income children with ADHD UOT or CBM Researchers will test the comparative effectiveness of UOT to CBM with low-income children with ADHD a new patient population for UOT
3 Are the effects of UOT and CBM sustained 9-12 months after treatment Researchers will assess whether any benefits ascribed to the interventions are maintained about a year after the treatment is completed
Patients with ASD and ADHD will be recruited for the study from school systems Half will receive UOT and half will receive CBM Researchers will recruit interested Title 1 schools that serve very different and diverse populations Recruitment will occur in several stages Specifically school districts will invite individual schools to participate in the trial that have a sufficient number of qualifying children Interested schools will then contact families and provide information about the study Interested families will initiate contact with study staff and individual schools will be entered into the study if they have three or more patients whose families contact study staff Children will then be scheduled for cognitivediagnostic evaluation Recruitment will continue until the target enrollment is reached and all remaining interested families from enrolled schools are included Subjects with appropriate assent and consent will be evaluated for eligibility and their school will be randomly assigned to treatment condition
Cognitive problem-solving abilities flexibility planning and organizing self-regulation behavior problems coping skills and the childs use of non-routine urgent medical care will be measured before and after treatment through a multi-method multi-informant format including parent report blinded classroom observations and blinded direct child measures Researchers chose measures that have the greatest relevance to functional outcomes and real world functioning Rather than define a single outcome researchers chose multiple outcome variables anticipating differential impacts of the treatment modalities on the outcome domains All of the measures and observations will be gathered at pre- and post-treatment time-points in each treatment year
Data will be analyzed using a Statistical Package for the Social Sciences SPSS v20 and R A comparison of baseline characteristics will be performed between the treatment groups to assess that the randomization was successful The characteristics will include demographics as well as the direct child assessments and the behavioral scales These comparisons will be performed using standard statistical methods such as t-tests for continuous variables or exact chi-squares for dichotomous variables If any characteristic is unbalanced between treatments which will be possible with the sample size secondary analyses will adjust for that characteristic
1 Which works better for low-income children with ASD UOT or CBM Researchers will test the comparative effectiveness of UOT to CBM treatments with low-income children with ASD
2 Which works better for low-income children with ADHD UOT or CBM Researchers will test the comparative effectiveness of UOT to CBM with low-income children with ADHD a new patient population for UOT
3 Are the effects of UOT and CBM sustained 9-12 months after treatment Researchers will assess whether any benefits ascribed to the interventions are maintained about a year after the treatment is completed
Patients with ASD and ADHD will be recruited for the study from school systems Half will receive UOT and half will receive CBM Researchers will recruit interested Title 1 schools that serve very different and diverse populations Recruitment will occur in several stages Specifically school districts will invite individual schools to participate in the trial that have a sufficient number of qualifying children Interested schools will then contact families and provide information about the study Interested families will initiate contact with study staff and individual schools will be entered into the study if they have three or more patients whose families contact study staff Children will then be scheduled for cognitivediagnostic evaluation Recruitment will continue until the target enrollment is reached and all remaining interested families from enrolled schools are included Subjects with appropriate assent and consent will be evaluated for eligibility and their school will be randomly assigned to treatment condition
Cognitive problem-solving abilities flexibility planning and organizing self-regulation behavior problems coping skills and the childs use of non-routine urgent medical care will be measured before and after treatment through a multi-method multi-informant format including parent report blinded classroom observations and blinded direct child measures Researchers chose measures that have the greatest relevance to functional outcomes and real world functioning Rather than define a single outcome researchers chose multiple outcome variables anticipating differential impacts of the treatment modalities on the outcome domains All of the measures and observations will be gathered at pre- and post-treatment time-points in each treatment year
Data will be analyzed using a Statistical Package for the Social Sciences SPSS v20 and R A comparison of baseline characteristics will be performed between the treatment groups to assess that the randomization was successful The characteristics will include demographics as well as the direct child assessments and the behavioral scales These comparisons will be performed using standard statistical methods such as t-tests for continuous variables or exact chi-squares for dichotomous variables If any characteristic is unbalanced between treatments which will be possible with the sample size secondary analyses will adjust for that characteristic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None