RECRUITING Not applicable ClinicalTrials.gov

Empowering Caregivers to Promote Child Independence

Sponsor: University of Nebraska • ClinicalTrials.gov ID: NCT07059364

Registry updated: 2026-09-24

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Description

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.

Interventions

CAST Treatment (Behavioral)
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.

Eligibility criteria

Inclusion Criteria: * Autistic individuals 10 to 17 years of age * Severe or profound intellectual disability diagnosis or reportedly in line with diagnostic criteria based on Autism Diagnostic Observation Schedule, Second Edition ADOS-2 * Developmental Profile 4 (DP-4) Cognitive/Communication Domain scores below 70 (Delayed) * Adaptive Behavior Assessment System (ABAS-3) Communication, Health and Safety, and Leisure Domains adaptive skill scores in the Low to Extremely Low range * Can complete between 3-10 simple leisure or daily living skill tasks or activities independently (caregiver may prompt or provide oversight) * Caregivers can remain present to assist with toileting if more than one person is needed to assist * No medication or stable medication regimen with no planned changes for study duration * Stable intervention and/or educational services with no planned changes for study duration * English spoken by at least one caregiver Exclusion Criteria: * Known serious medical condition or serious behavioral/psychiatric condition requiring immediate alternative focused intervention

Conditions

Profound Autism

Locations

Munroe-Meyer Insitute University of Nebraska Medical Center — Omaha, Nebraska, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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