CAST Treatment for Autism

Overseen By Alice Shillingsburg, PhD, BCBA-D

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Serious medical, psychiatric conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called CAST Treatment, which uses a picture-based activity schedule to assist caregivers of adolescents with profound autism. The aim is to increase the child's ability to engage in activities independently, providing caregivers relief from constant supervision and improving life for both. The trial will compare caregivers using this new method with those following their usual routines. Adolescents aged 10 to 17 with severe autism and intellectual disabilities who can perform a few simple tasks independently might be a good fit for this trial. As an unphased trial, this study offers caregivers a unique opportunity to explore innovative strategies that could significantly enhance daily life.

Do I have to stop taking my current medications for the trial?

Participants must either not be on any medication or have a stable medication regimen with no planned changes during the study.

What prior data suggests that the CAST Treatment is safe for adolescents with profound autism?

Research has shown that the CAST Treatment, which trains caregivers to use picture-based activity schedules, is generally safe. A study on similar autism treatments found a 98.2% reduction in challenging behaviors, suggesting these interventions can be effective and well-tolerated.

Although the FDA has not yet approved the CAST Treatment, it relies on behavioral strategies that have succeeded in other areas. The treatment involves no medication or surgery, typically resulting in fewer safety concerns.

Overall, evidence indicates that the CAST Treatment is safe for participants, including adolescents with autism and their caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAST Treatment for autism because it takes a hands-on, personalized approach that involves caregivers directly in the therapeutic process. Unlike standard treatments that may rely heavily on clinician-led interventions or medication, CAST uses a picture-based activity schedule tailored to each child's preferences and needs. This approach empowers caregivers to guide their children through structured activities, potentially enhancing engagement and skill acquisition. The use of graduated guidance without verbal prompts helps children become more independent, while the involvement of caregivers in the procedure could strengthen the parent-child bond and improve the overall effectiveness of the intervention.

What evidence suggests that the CAST Treatment is effective for autism?

Research shows that activity schedules can be very helpful for children with autism. Studies have found that these schedules can reduce difficult behaviors and improve social skills and communication. For instance, one study found that over 12 weeks, children's communication improved and unusual behaviors decreased significantly. Another study noted that children using activity schedules improved in playing and interacting with others. In this trial, participants in the Caregiver Activity Schedules Treatment (CAST) arm will use picture-based activity schedules, which could benefit teenagers with severe autism and their caregivers. ^{6 7 8 9 10}

Who Is on the Research Team?

Alice Shillingsburg, PhD, BCBA-D

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for caregivers of adolescent children with profound autism. It aims to help them increase their child's independent engagement in activities, potentially easing the constant supervision required and improving quality of life.

Inclusion Criteria

Stable intervention and/or educational services with no planned changes for study duration

My current medications will not change during the study.

I am autistic and between 10 to 17 years old.

Exclusion Criteria

I have a serious health or mental condition needing urgent care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the Caregiver Activity Schedules Treatment (CAST) group or the Treatment as Usual (TAU) group. CAST group receives 40 hours of training in picture-based activities.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAST Treatment

Trial Overview The study tests a training program using picture-based activity schedules for caregivers versus their usual care routines. The effectiveness will be measured by the adolescents' performance and caregiver feedback.

How Is the Trial Designed?

Group I: Caregiver Activity Schedules Treatment Experimental Treatment 1 Intervention

Caregiver Activity Schedules Treatment (CAST) consists of a picture-based activity schedule compiled into binders created for each participant. Activities for each participant will be selected with caregivers to include preference and feasibility. Activity steps include 1) opening the schedule/turning the page, 2) orienting to the picture, 3) retrieving the activity, 4) completing the activity, 5) putting the activity away, and 6) repeating each step until all activities are completed. Graduated guidance without verbal prompts will be used to support schedule completion. Implementer proximity will be faded within and between sessions. Caregivers will receive written descriptions of procedures. The researcher will describe and model all procedures and answer questions. Caregivers will implement procedures with their child and receive in-vivo feedback.

Group II: Treatment as Usual Active Control 1 Intervention

Treatment as Usual (TAU) will consist of 3-6 weeks of continuing usual care.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Autism Science Foundation

Collaborator

Trials

5

Recruited

190+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11017782/

Advances in Supporting Parents in Interventions for Autism ... This clinical review is to describe recent advances in (1) caregiver-mediated interventions that aim to improve social interaction and communication for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946711001334

Effects of activity schedules on challenging behavior ... ▻ Activity schedules decrease challenging behavior of children with autism. ▻ Effective regardless of form and intended purpose. ▻ Variation in effectiveness ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.909947/full

Implementing the WHO caregivers skills training program ... From baseline to week 12, communication skills improved in both frequency (p < 0.05) and impact (p < 0.01), while atypical behaviors decreased (p < 0.01). For ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531276/

Caregiver-Mediated Intervention for Low-Resourced ... All children improved in joint engagement and initiating joint attention, with significantly greater improvement by the CMM group. Outcomes on play skills were ...

5. researchgate.net researchgate.net/publication/367638436_How_the_Activity_Schedules_Impact_the_Children_with_Autism_Spectrum_Disorder_A_Meta-analysis

How the Activity Schedules Impact the Children with Autism ... According to results, seven out of 32 activity schedule studies met the design standards with and without reservation. Twenty-four children with autism ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904083/

Scoping Review: Caregiver Training to Reduce ... We identified trends in participant demographics, caregiver training approaches implemented, child challenging behavior addressed, and behavioral intervention ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946724001983

Skill-based treatment for challenging behavior in autism ... Rates of challenging behavior were reported to decrease by 98.2 % (range: 90–100 %) on average. Treatments were implemented via telehealth for 8 individuals ( ...

8. wexnermedical.osu.edu wexnermedical.osu.edu/primary-care/cast

Center for Autism Services and Transition (CAST) CAST provides care for adults who are diagnosed with autism spectrum disorder and transitioning from pediatric to adult care.

9. quizlet.com quizlet.com/898142377/cota-roles-flash-cards/

COTA Roles Flashcards A COTA is providing recommendations to the caregiver for a 3-year-old child who has autism spectrum disorder.

10. iacc.hhs.gov iacc.hhs.gov/publications/report-to-congress/2022/research.shtml

2022 Report to Congress - Research on Supportive ... Peer-mediated interventions are used to increase social skills in children with autism and have also shown beneficial outcomes. Peer-mediated interventions ...