Improving Academic and Social Functioning in Middle-Schoolers With Autism
2 other identifiers
interventional
224
1 country
1
Brief Summary
The goal of this study is to test how well two group interventions work for middle-school children with Autism Spectrum Disorder (ASD). One of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. Eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2024
CompletedFirst Posted
Study publicly available on registry
November 26, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
March 17, 2026
March 1, 2026
4.5 years
November 23, 2024
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Behavior Rating Inventory of Executive Functioning, 2nd Edition
The BRIEF-2 assesses real-world EF behaviors in the home and school environments. The T-scores range from 30:99 with higher scores being worse.
From enrollment to the end of treatment at 8 weeks.
Homework Problems Checklist
The HPC assesses Homework Completion and Homework Management. Scores for Homework Completion range from 0 to 36 and for Homework Management from 0 to 21. Lower scores are better.
From enrollment to end of treatment at 8 weeks.
Academic Performance Rating Scale
The teacher-completed APRS assesses how well the adolescent is performing academically with 3 subscales (Academic Success, Academic Productivity, and Impulse Control). The two scores to be used in the current study include the Academic Success score which ranges from 7 to 35, while the Academic Productivity score ranges from 12 to 60. Higher scores are better.
From enrollment to end of treatment at 8 weeks.
Secondary Outcomes (3)
Children's Organizational Skills Scale
From enrollment to the end of treatment at 8 weeks.
Weekly Calendar Planning Activity
From enrollment to the end of treatment at 8 weeks.
Social Skills Assessment (TRIAD)
From enrollment to the end of treatment at 8 weeks.
Study Arms (2)
Achieving Independence & Mastery in School (AIMS)
EXPERIMENTALAIMS targets executive functioning skills using evidence-based strategies for youth with ASD to promote increased independence related to academics. Each session involves a review of a real world practice assignment and a didactic component illustrating key concepts followed by an in-session practice of the key concepts and strategies with coaching from a therapist. A behavior agreement is used to identify specific goals for adolescents to work on in collaboration with their caregivers and specific rewards earned for meeting their goals. Adolescents are assigned a real world practice assignment each session that consists of additional practice of strategies to further build and generalize skills between sessions.
Building Essential Social Skills for Teens (BESST)
ACTIVE COMPARATORBESST targets social skills using evidence-based strategies and includes sessions related to starting, joining, maintaining, and ending conversations and making, maintaining, and deepening friendships. Each skill will be introduced in a didactic lesson which includes modeling of the targeted skill by a therapist. Adolescents will role-play new skills during the session before receiving a homework assignment to practice the skill at home. Caregivers will receive training in social-communication difficulties in ASD and suggestions for supporting development of these skills. The sessions are specifically focused on generalizing newly learned skills to both home and school.
Interventions
Intervention targeting academic executive functioning
Intervention targeting social skills
Eligibility Criteria
You may qualify if:
- Diagnosis of autism
- No intellectual disability
- Problems with organization, materials management, and planning and prioritization
- Problems with social skills
- Fully included in middle school
- Stable medication and behavioral treatment regime
You may not qualify if:
- Home schooled
- Severe co-occurring psychopathology (e.g., aggression, suicidal)
- Non English-speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leanne Tamm, Ph.D.
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Amie Duncan, Ph.D.
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2024
First Posted
November 26, 2024
Study Start
December 1, 2024
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- August 31, 2029
- Access Criteria
- Investigators interested in using the data obtained in this study will be directed to obtain the data from NDA. Other materials can be obtained from the study principal investigators upon reasonable request.
All collected IPD will be entered into NIMH's Data Archive (NDA) in order to contribute to the advancement of research on individuals with ASD. In our Background History Form, we will collect the prerequisite information (i.e., specific information such as legal name, date of birth, sex, and city of birth) needed to generate a GUID. Informed consent documents will inform participants that their data will be entered into NDA.