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Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting (TASK-R21)

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ClinicalTrials.gov Identifier: NCT03606343
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Teaching Academic Skills to Kids Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Teaching Academic Success Skills to Middle School Students With Autism Spectrum Disorders (ASD) With Executive Functioning Deficits - in Clinical Setting
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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
Behavioral: Teaching Academic Skills to Kids
Group treatment




Primary Outcome Measures :
  1. change in scores on Children's Organizational Skills Scale [ Time Frame: baseline, 3 months ]
    rating scale of executive functioning (T scores with higher scores worse)

  2. change in scores on Behavior Rating Inventory of Executive Function - Second Edition [ Time Frame: baseline, 3 months ]
    rating scale of executive functioning (T scores with higher scores worse)

  3. change in scores on Homework Problem Checklist [ Time Frame: baseline, 3 months ]
    rating scale of homework behavior (two subscale scores, higher scores worse)


Secondary Outcome Measures :
  1. change in scores on Woodcock Johnson Tests of Achievement - Third Edition [ Time Frame: baseline, 3 months ]
    academic performance measure (standard scores with lower scores worse)

  2. change in ratings on Classroom Performance Survey [ Time Frame: baseline, 3 months ]
    teacher rating scale of classroom behavior (subscale scores with higher scores worse)

  3. change in ratings on Academic Performance Rating System [ Time Frame: baseline, 3 months ]
    teacher rating scale of academic performance (subscale scores with higher scores worse)

  4. change in scores on Parenting Relationship Questionnaire [ Time Frame: baseline, 3 months ]
    parent rating scale of relationship (T-scores with higher scores worse)



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606343


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03606343     History of Changes
Other Study ID Numbers: R21HD090334-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with other researchers via the National Database for Autism Research (NDAR) without exposing personally identifiable information.
Supporting Materials: Study Protocol
Time Frame: after August 31, 2019 when study is completed, indefinitely available.
Access Criteria: specified by NDAR
URL: http://ndar.nih.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders