Improving Academic and Social Functioning in Middle-Schoolers With Autism

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Achieving Independence and Mastery in School (AIMS); Behavioral: Building Essential Social Skills for Teens (BESST)

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leanne Tamm, Ph.D.; Phone Number: 513-803-3176; Email: leanne.tamm@cchmc.org
• Study Contact Backup: Name: Amie Duncan, Ph.D.; Phone Number: 513-803-2416; Email: amie.duncan@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital
      • Contact: Ellie Thoma; Phone Number: 513-636-5994; Email: skillsbuilder@cchmc.org
      • Principal Investigator: Leanne Tamm, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Achieving Independence and Mastery in School (AIMS); Intervention targeting academic executive functioning; Other Names: AIMS
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.	Behavioral: Building Essential Social Skills for Teens (BESST); Intervention targeting social skills; Other Names: BESST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Organizational Skills Scale	The COSS is a psychometrically strong rating scale assessing Organized Actions, Task Planning, and Memory & Materials Management. The T scores for each subscale range from 20 to 83 and higher scores indicate worse functioning.	From enrollment to the end of treatment at 8 weeks.
Weekly Calendar Planning Activity	The WCPA is an objective measure of metacognition (i.e., planning, inhibition, problem solving, keeping track of rules, and monitoring passage of time) while performing a multiple-step activity (i.e., scheduling multiple appointments while adhering to various rules). The WCPA will report total appointments entered (0 to 10) and total correct appointments entered (0 to 10) with higher values being better.	From enrollment to the end of treatment at 8 weeks.
Social Skills Assessment (TRIAD)	The TRIAD assesses social skills (i.e., emotion understanding and perspective taking, initiating and ending interactions, responding to others, maintaining interactions and problem solving, and following social rules) rated on a 1 to 4 scale (1=not very well to 4=very well). Items rated 2 or less are considered areas of weakness. Items rated as 3 or above are considered areas of strength.	From enrollment to the end of treatment at 8 weeks.

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Leanne Tamm, Ph.D., Children's Hospital Medical Center, Cincinnati; Principal Investigator: Amie Duncan, Ph.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: November 23, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: social skills; middle school; executive functions; academic achievement
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Social Behavior; Autism Spectrum Disorder; Autistic Disorder; Social Skills; Non-Medical Public and Private Facilities; Schools
• Other Study ID Numbers: IRB#2024-0148; 1R01HD113534-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: August 31, 2029
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No