AutismNCT06705907
Improving Academic and Social Functioning in Middle-Schoolers With Autism
A study testing Achieving Independence and Mastery in School (AIMS) and Building Essential Social Skills for Teens (BESST) in people with Autism and Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Achieving Independence and Mastery in School (AIMS) and Building Essential Social Skills for Teens (BESST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Home schooled
- Severe co-occurring psychopathology (e.g., aggression, suicidal)
- Non English-speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Abigail Lim, 513-636-5995, skillsbuilder@cchmc.org
Leanne Tamm, Ph.D.
About this study
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
- Being tested
- Achieving Independence and Mastery in School (AIMS), Building Essential Social Skills for Teens (BESST)
- Keywords
- social skills, executive functions, academic achievement, middle school
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achieving Independence and Mastery in School (AIMS)Behavioural
Also called AIMS
Intervention targeting academic executive functioning
Building Essential Social Skills for Teens (BESST)Behavioural
Also called BESST
Intervention targeting social skills
| Study group | Role | What they receive |
|---|---|---|
| Achieving Independence & Mastery in School (AIMS) | Experimental | 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. Receives: Behavioral: Achieving Independence and Mastery in School (AIMS) |
| Building Essential Social Skills for Teens (BESST) | Active comparator | 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. Receives: Behavioral: Building Essential Social Skills for Teens (BESST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 8 weeks.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024
- Primary completion31 May 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Leanne Tamm, Ph.D., Principal investigator, Children's Hospital Medical Center, CincinnatiAmie Duncan, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705907
- Sponsor's protocol ID
- IRB#2024-0148
- Other IDs
- 1R01HD113534-01A1
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.