Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06705907

Conditions

Autism

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Not accepted

Interventions

Achieving Independence and Mastery in School (AIMS)

Building Essential Social Skills for Teens (BESST)

Study Details

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.

Conditions

Autism

Autism Spectrum Disorder

Study ID

NCT06705907

Start date

Dec 1, 2024

Status verified date

Mar, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Home schooled
  • Severe co-occurring psychopathology (e.g., aggression, suicidal)
  • Non English-speaking

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Achieving Independence & Mastery in School (AIMS)

AIMS 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.

active comparator: Building Essential Social Skills for Teens (BESST)

BESST 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

Achieving Independence and Mastery in School (AIMS)

Intervention targeting academic executive functioning

Building Essential Social Skills for Teens (BESST)

Intervention targeting social skills

Primary outcome measure

  • Behavior Rating Inventory of Executive Functioning, 2nd Edition [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]
  • Homework Problems Checklist [ Time Frame: From enrollment to end of treatment at 8 weeks. ]
  • Academic Performance Rating Scale [ Time Frame: From enrollment to end of treatment at 8 weeks. ]

Central Contacts and Locations

Central contacts

Leanne Tamm, Ph.D.

513-803-3176leanne.tamm@cchmc.org

Amie Duncan, Ph.D.

513-803-2416amie.duncan@cchmc.org

Locations

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Ellie Thoma

513-636-5994skillsbuilder@cchmc.org

Principal Investigator:

Leanne Tamm, Ph.D.

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • social skills
  • executive functions
  • academic achievement
  • middle school

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-17.