- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03606343
Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting (TASK-R21)
Teaching Academic Success Skills to Middle School Students With Autism Spectrum Disorders (ASD) With Executive Functioning Deficits - in Clinical Setting
The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.
Aim 1: Use focus group methodology and advice from expert consultants to develop the TASK intervention targeting academic EF skills for middle school youth with ASD that is tailored to the unique needs of these individuals (e.g., content specific to ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD).
Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials to assess initial feasibility and efficacy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.
Aim 1: Develop the TASK intervention targeting academic EF skills for middle school youth with ASD that is tailored to the unique needs of these individuals (e.g., content specific to ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD). A methodologically rigorous, well-integrated iterative and collaborative design process with input from multiple stakeholders, including school mental health professionals, teachers, parents, and youth with ASD, will be utilized.
Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials including the feasibility of: 1) implementing the measurement protocol, 2) operationalizing intervention delivery, 3) assessing both trained and untrained areas of functioning, 4) assessing whether improvements in academic EF skills (proposed mechanism of treatment) are related to functional educational outcomes (e.g., homework behaviors, grades), and 5) exploring the data for potential treatment moderators (e.g., gender, severity). It is hypothesized that TASK will be feasible, acceptable (attendance, satisfaction), and will result in improved academic EF skills associated with reduced academic impairment and homework problems.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of autism spectrum disorder
- IQ >80
- 7th grade at time of intervention
- mainstreamed classroom
- executive functioning problems identified on parent or teacher BRIEF-2
Exclusion Criteria:
- danger to self or others
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open Trial
Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills.
Likely to be 7 90-minute sessions attended weekly by parents and teens
|
Group treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Organizational Skills Scale
Time Frame: baseline, 3 months
|
The Children's Organizational Skills Scale is a rating scale of organization and executive functioning.
A T-score is reported.
A T-score of 50 indicates the population mean with a standard deviation of 10.
Range of possible T-scores is 40 to 90.
Higher T-scores indicate poorer organization/executive functioning.
We present baseline (before intervention) and 3 month outcome (post intervention) T-scores as rated by the parent.
|
baseline, 3 months
|
Behavior Rating Inventory of Executive Function - Second Edition
Time Frame: baseline, 3 months
|
The Behavior Rating Inventory of Executive Function - Second Edition is a parent rating scale of executive functioning.
A T-score is reported.
A T-score of 50 indicates the population mean with a standard deviation of 10.
Range of possible T-scores is 40 to 90.
Higher T-scores indicate poorer executive functioning.
We present baseline (before intervention) and 3 month outcome (post intervention) T-scores.
|
baseline, 3 months
|
Homework Problem Checklist
Time Frame: baseline, 3 months
|
The Homework Problem Checklist is a rating scale of homework behavior completed by the parent.
There are two subscales generated: Homework Completion Behaviors & Homework Management Behaviors.
Scale is rated on a 0 = never to 3 = very often scale and a sum of scores is computed for each subscale.
Range of scores for Homework Completion Behaviors is 0 to 36.
Range of scores for Homework Management Behaviors is 0 to 21.
We present baseline (before intervention) and 3 month outcome (post intervention) scores for each subscale.
Higher scores indicate worse outcome.
|
baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest
Time Frame: baseline, 3 months
|
The Woodcock Johnson is an academic performance measure administered to the child.
A standard score of 100 indicates the population mean with a standard deviation of 15 (range of 40 to 170).
Lower standard scores are worse.
We present baseline (before intervention) and 3 month outcome (post intervention) for the Basic Writing subtest.
|
baseline, 3 months
|
Classroom Performance Survey
Time Frame: baseline, 3 months
|
The Classroom Performance Survey is a teacher rating scale of classroom behavior.
The scale is rated 1 = always to 5 = never.
An academic competence mean score is computed (range 1 to 5) with higher scores indicating a worse outcome.
We present baseline (before intervention) and 3 month outcome (post intervention) total mean score.
|
baseline, 3 months
|
Academic Performance Rating System
Time Frame: baseline, 3 months
|
The Academic Performance Rating System is a teacher rating scale of academic performance.
Items are rated 1 = Never to 5 = Very often and the items are summed to generate a Total Score (range 19 to 95) with higher scores worse indicating a worse outcome.
We present the Total score at baseline (before intervention) and 3 month outcome (post intervention).
|
baseline, 3 months
|
Parenting Relationship Questionnaire - Communication Subscale
Time Frame: baseline, 3 months
|
The Parenting Relationship Questionnaire is completed by parents to describe their parenting relationship with the teen.
A T-score is reported for the Communication subscale.
A T-score of 50 indicates the population mean with a standard deviation of 10.
Range of possible T-scores is 40 to 90.
Lower T-scores indicate poorer communication.
We present baseline (before intervention) and 3 month outcome (post intervention) T-scores.
|
baseline, 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21HD090334-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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