An interventional study of CAST Treatment in Profound Autism, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
The proposed study aims to address the unique needs of caregivers and their adolescent children with profound autism. The constant supervision and 24/7 care that caregivers need to provide their children to ensure their health and safety often leaves little time for household duties, self-care routines, and spending time with family and friends. Investigators aim to alleviate the vigilant monitoring provided by caregivers for brief periods by increasing their child's independent, sustained engagement in meaningful activities and improving the quality of life for both adolescents with profound autism and their caregivers. Caregivers will either receive training to use picture-based activity schedules or continue with their usual routines. After the study, caregivers who continued their usual routines will also be offered the training. Investigators will evaluate the feasibility and acceptability of the training based on the children's performance, pre- and post-study improvement ratings, and caregiver feedback.
Approximately 25% of children with autism are estimated to meet the criteria for profound autism. Profound autism describes those with the greatest support needs because of the coinciding significant intellectual disability and limited/absent verbal communication. Because individuals with profound autism have been excluded from research, the investigator's understanding of effective assessments and interventions for this population and their families is incomplete. One defining feature associated with caring for a child with profound autism is the 24/7 supervision required from caregivers, often described as a feeling of constant vigilance. Although previous research on the matter may not use the specific term, profound autism, much can be gleaned from studies of caregivers with adult autistic children who cannot be left alone, autistic children with co-occurring intellectual disability, or older studies including children with IQ scores below 50 before autism was well understood. Caregivers facing these 24/7 obligations experience increased time constraints that prevent their self-care routines, limit time with family and friends, and reduce time spent on personal interests and work-related activities. Caregivers also report reduced time spent sleeping, preparing meals, and completing other household duties. Some report being unable to leave their child unattended for as little as 5 minutes. Relatedly, caregivers of profoundly autistic children report some of their greatest hopes for their children to be increased independence and autonomy to engage in enjoyable activities. Teaching autistic children how to engage appropriately with items can increase independent leisure engagement and increasing sustained activity engagement can promote autonomy and overall well-being. Therefore, interventions that promote independent, sustained engagement with activities could simultaneously benefit people with profound autism and their caregivers. However, characteristic restricted interests and repetitive behaviors can impede sustained activity engagement and interfere with transitioning to new activities. Thus, additional environmental supports, such as visuals, are sometimes needed. Picture-based activity schedules are an evidence-based practice that promotes sustained engagement with activities with reduced adult assistance. However, additional research is necessary to evaluate this intervention for individuals with profound autism and their caregivers.
The proposed study focuses on alleviating vigilant-level supervision provided by caregivers for brief periods while simultaneously increasing independent, sustained engagement with meaningful activities for their adolescent children with profound autism. Participants will randomly be assigned to either the Caregiver Activity Schedules Treatment (CAST) group and receive 40 hours of training in picture-based activities or be assigned to the Treatment as Usual (TAU) group. The TAU group will be offered CAST training following the trial. The feasibility, acceptability, and preliminary efficacy will be evaluated using measures of participant performance, participant affect, clinician ratings, and independent evaluation by an expert using the Clinical Global Impressions Improvement Scale (CGI-I).
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 32 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
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Exclusion Criteria:
Treatment as Usual (TAU) will consist of 3-6 weeks of continuing usual care.
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.
Behavioral: CAST Treatment
Activity completion will be evaluated based the number of consecutive and total activities completed, duration of sustained activity engagement, prompts or redirection, and adult proximity at baseline and post-trial.
Number of Participant Accrued
Number of caregivers who accept random assignment as determined by refusal rate of eligible participants.
Time frame: Until accrual is complete, approximately 1 year
Rate of Participant Attrition
Participant attrition rate will be determined over the course of the study.
Time frame: Up to 6 weeks
Ratings of Caregiver Activity Schedules Treatment Acceptability
The acceptability of the Caregiver Activity Schedules Treatment (CAST) intervention by the caregiver will be measured using a 1 to 5 scale (anchored by 1 strongly disagree, and 5, strongly agree) by average ratings of agree (4) or strongly agree (5) to all acceptability rating scale statements and adolescents willingness to participate in intervention sessions.
Time frame: Up to 6 weeks
Caregiver Reported Continued Use of Activity Schedules Treatment
The reported continued use of the Caregiver Activity Schedules Treatment activity schedules at home by the caregiver will be determined at 6-weeks by responses to a 5 question open-ended questionaire.
Time frame: Up to 6 weeks
Total Number of Activities Completed
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of total activities completed at baseline and post-trial.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Number of Consecutive Activities Completed
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of consecutive activities completed at baseline and post-trial.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Duration of Sustained Activity Engagement
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the duration of sustained activity engagement at baseline and post-trial.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Number of Prompts to Complete Activities
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of prompts needed to complete activities at baseline and post-trial.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Number of Redirections to Stay on Task
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of redirections to stay on task at baseline and post-trial.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Caregiver Proximity to Their Child
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the caregiver proximity to their child at baseline and post-trial.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Improvement Ratings on the Clinical Global Impressions - Improvement Scale
The Clinical Global Impressions - Improvement Scale (CGI-I) is a 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse). An independent evaluator (IE) will assess data recorded from direct observation (i.e., number of activities completed, duration of sustained engagement, amount and type of adult support provided) of the participant and caregiver at baseline and post-trial. Additionally, the IE will consider the baseline and post-trial Parent Target Problems (PTP) narratives which document caregiver-nominated target problems in specific areas of concern identified through conversation with caregivers. Using this information from baseline and post trial, the IE will yeild an improvement rating on the CGI-I.
Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks
Plan to share: Yes — All study outcome measures will be shared with the National Database for Autism Reserch. Global Unique Identifiers will be used to share data from the study and all indentifying participant information will be removed before sharing.
Time frame: October 1, 2025
Access criteria: All IPD and supporting information will be availabile in the open science data repository the National Database for Autism Research (NDAR)
Data sharing details ↗ · nda.nih.gov
Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 24 months is close to that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
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