NCT03606343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

May 16, 2018

Results QC Date

September 23, 2020

Last Update Submit

November 24, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    baseline, 3 months

Secondary Outcomes (4)

  • Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest

    baseline, 3 months

  • Classroom Performance Survey

    baseline, 3 months

  • Academic Performance Rating System

    baseline, 3 months

  • Parenting Relationship Questionnaire - Communication Subscale

    baseline, 3 months

Study Arms (1)

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

Behavioral: Teaching Academic Skills to Kids

Interventions

Group treatment

Open Trial

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of autism spectrum disorder
  • IQ \>80
  • th grade at time of intervention
  • mainstreamed classroom
  • executive functioning problems identified on parent or teacher BRIEF-2

You may not qualify if:

  • danger to self or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Leanne Tamm, Principal Investigator
Organization
Cincinnati Children's Hospital Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

July 30, 2018

Study Start

September 1, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

December 17, 2020

Results First Posted

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
after August 31, 2019 when study is completed, indefinitely available.
Access Criteria
specified by NDAR
More information

Locations