Recruiting

Activity Schedule Training

Sponsor:

University of Nebraska

Code:

NCT07059364

Conditions

Profound Autism

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

CAST Treatment

Study Details

Brief summary:

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.

Conditions

Profound Autism

Study ID

NCT07059364

Start date

Jul 15, 2025

Status verified date

Jul, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Treatment as Usual

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

experimental: Caregiver Activity Schedules Treatment

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.

Interventions

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.

Primary outcome measure

  • Number of Participant Accrued [ Time Frame: Until accrual is complete, approximately 1 year ]
  • Rate of Participant Attrition [ Time Frame: Up to 6 weeks ]
  • Ratings of Caregiver Activity Schedules Treatment Acceptability [ Time Frame: Up to 6 weeks ]
  • Caregiver Reported Continued Use of Activity Schedules Treatment [ Time Frame: Up to 6 weeks ]

Central Contacts and Locations

Central contacts

Alice Shillingsburg, PhD, BCBA-D

402-559-3098ashillingsburg@unmc.edu

Emily Sullivan, PhD, BCBA-D

402-559-8863esullivan@unmc.edu

Locations

Munroe-Meyer Insitute University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68106

Contacts

Amanda Oliver, MA

402-552-3076aoliver@unmc.edu

Emily Sullivan, PhD, BCBA-D

402-559-8863esullivan@unmc.edu

Principal Investigator:

Alice Shillingsburg, PhD, BCBA-D

More Information

Sponsor

University of Nebraska

Last update posted

Oct 10, 2025

Last verified

Jul, 2025

Keywords

  • Profound Autism
  • Picture-Based Activity Schedules
  • Caregiver Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Nebraska on 2025-10-10.