Empowering Caregivers to Promote Child Independence
ConditionProfound Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorUniversity of Nebraska
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known serious medical condition or serious behavioral/psychiatric condition requiring immediate alternative focused intervention
Trial design
Design model
Parallel
Treatments tested in this trial
CAST Treatment
BehavioralActivity 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Treatment as UsualNo intervention 0 interventions
Group B: Caregiver Activity Schedules TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 year2
Rate of Participant Attrition
Participant attrition rate will be determined over the course of the study.
Time frame
Up to 6 weeks3
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 weeks4
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nebraska
Lead sponsor
Autism Science Foundation
Collaborator
Source ClinicalTrials.gov