Autism Spectrum DisorderTASK-R21NCT03606343
Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting
A study testing Teaching Academic Skills to Kids in people with Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Teaching Academic Skills to Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 31 Aug 2020
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- danger to self or others
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Teaching Academic Skills to Kids
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching Academic Skills to KidsBehavioural
Group treatment
| Study group | Role | What they receive |
|---|---|---|
| Open Trial | Experimental | 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 Receives: Behavioral: Teaching Academic Skills to Kids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Organizational Skills Scale
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.
Measured: baseline, 3 months
Behavior Rating Inventory of Executive Function - Second Edition
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.
Measured: baseline, 3 months
Homework Problem Checklist
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.
Measured: baseline, 3 months
Secondary outcomes (4)
Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest
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.
Measured: baseline, 3 months
Classroom Performance Survey
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.
Measured: baseline, 3 months
Academic Performance Rating System
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).
Measured: baseline, 3 months
Parenting Relationship Questionnaire - Communication Subscale
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.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Sep 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606343
- Sponsor's protocol ID
- R21HD090334-01A1
- Acronym
- TASK-R21
- Status last verified
- Nov 2020
- First submitted
- 16 May 2018
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers via the National Database for Autism Research (NDAR) without exposing personally identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Academic Success Skills to Middle School Students With Autism Spectrum Disorders (ASD) With Executive Functioning Deficits - in Clinical Setting
- ClinicalTrials.gov ID
- NCT03606343
- Acronym / sponsor ID
- TASK-R21 / R21HD090334-01A1
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open trial
| Arm | Type | Receives |
|---|---|---|
| Open Trial | Experimental | Behavioral: Teaching Academic Skills to KidsGroup 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 |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- danger to self or others
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 |
|---|---|---|
| Teaching Academic Skills to KidsGroup treatment | Behavioural | Open Trial |
Primary outcome
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.
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.
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.
4 secondary outcomes
Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest
Time frame: baseline, 3 months
Classroom Performance Survey
Time frame: baseline, 3 months
Academic Performance Rating System
Time frame: baseline, 3 months
Parenting Relationship Questionnaire - Communication Subscale
Time frame: baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers via the National Database for Autism Research (NDAR) without exposing personally identifiable information.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching Academic Skills to Kids in people with Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati 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 5 inclusion and 1 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 17 Dec 2020. 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 24 Nov 2020). 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?
Children's Organizational Skills Scale (time frame: baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.