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

November 24, 2020 updated by: Children's Hospital Medical Center, Cincinnati

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21HD090334-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with other researchers via the National Database for Autism Research (NDAR) without exposing personally identifiable information.

IPD Sharing Time Frame

after August 31, 2019 when study is completed, indefinitely available.

IPD Sharing Access Criteria

specified by NDAR

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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