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NCT07059364From ClinicalTrials.govRecruiting

Empowering Caregivers to Promote Child Independence

Empowering Caregivers to Promote Child Independence and Persistence With Activities

  • Profound Autism

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
University of Nebraska
Enrolment target
32
Started
15 July 2025
Main results due
July 2027
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Ages 10 years to 17 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Munroe-Meyer Insitute University of Nebraska Medical Center

    Omaha, Nebraska, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07059364. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Empowering Caregivers to Promote Child Independence | Trialion