NCT03606343: TASK-R21

Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting

Completed NA Results posted Last updated 17 December 2020

What this trial tests

NA trial testing Teaching Academic Skills to Kids in Autism Spectrum Disorder in 21 participants. Completed in 31 August 2020.

Timeline

1 September 2017

Primary endpoint
31 August 2020

31 August 2020

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 September 2017
Primary completion	31 August 2020
Estimated completion	31 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Teaching Academic Skills to Kids

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 11 to 14, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Children's Organizational Skills Scale Primary · 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 Parent Total COSS T-Score

Group	Value	95% CI
Open Trial	66.14	± 9.43

3 months Parent Total COSS T-Score

Group	Value	95% CI
Open Trial	57.24	± 9.96

Behavior Rating Inventory of Executive Function - Second Edition Primary · 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 Parent General Executive Composite T-Scor

Group	Value	95% CI
Open Trial	71.86	± 8.62

3 month Parent General Executive Composite T-Scor

Group	Value	95% CI
Open Trial	66.57	± 8.78

Homework Problem Checklist Primary · 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 Homework Completion Behaviors

Group	Value	95% CI
Open Trial	24.24	± 6.58

3 Month Homework Completion Behaviors

Group	Value	95% CI
Open Trial	15.71	± 7.63

Baseline Homework Management Behaviors

Group	Value	95% CI
Open Trial	8.33	± 6.09

3 Month Homework Management Behaviors

Group	Value	95% CI
Open Trial	4.57	± 4.40

Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest Secondary · 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 WJ-III Basic Writing

Group	Value	95% CI
Open Trial	103.85	± 11.91

3 Month WJ-III Basic Writing

Group	Value	95% CI
Open Trial	105.80	± 13.51

Classroom Performance Survey Secondary · 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 Academic Competence

Group	Value	95% CI
Open Trial	2.02	± .95

3 Month Academic Competence

Group	Value	95% CI
Open Trial	1.91	± 0.93

Academic Performance Rating System Secondary · 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 APRS Total

Group	Value	95% CI
Open Trial	45.83	± 12.14

3 Month APRS Total

Group	Value	95% CI
Open Trial	52.11	± 14.58

Parenting Relationship Questionnaire - Communication Subscale Secondary · 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 Communication T-Score

Group	Value	95% CI
Open Trial	41.1	± 8.7

3 Month Communication T-Score

Group	Value	95% CI
Open Trial	43.2	± 8.3

Sponsor's own 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: 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.