Profound Autism
Conditions
Keywords
Profound Autism, Picture-Based Activity Schedules, Caregiver Training
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.
Detailed description
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).
Interventions
BEHAVIORALCAST 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.
Sponsors
Autism Science Foundation
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to caregiver activity schedules training (CAST) or treatment as usual (TAU) in a 1:1 ratio according to permuted blocks. CAST consists of 40 hours of intervention in 2-hour appointments, 3-5 days/week, for 3-6 weeks. The appointment frequency and duration are intended to provide caregivers with flexibility and promote access to research. The TAU group will be offered CAST after their final assessment visit.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Accrued | Until accrual is complete, approximately 1 year | Number of caregivers who accept random assignment as determined by refusal rate of eligible participants. |
| Rate of Participant Attrition | Up to 6 weeks | Participant attrition rate will be determined over the course of the study. |
| Ratings of Caregiver Activity Schedules Treatment Acceptability | Up to 6 weeks | 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. |
| Caregiver Reported Continued Use of Activity Schedules Treatment | Up to 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Redirections to Stay on Task | Baseline (enrollment) to end of treatment, up to 6 weeks | Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of redirections to stay on task at baseline and post-trial. |
| Total Number of Activities Completed | Baseline (enrollment) to end of treatment, up to 6 weeks | Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of total activities completed at baseline and post-trial. |
| Improvement Ratings on the Clinical Global Impressions - Improvement Scale | Baseline (enrollment) to end of treatment, up to 6 weeks | 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. |
| Caregiver Proximity to Their Child | Baseline (enrollment) to end of treatment, up to 6 weeks | Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the caregiver proximity to their child at baseline and post-trial. |
| Number of Consecutive Activities Completed | Baseline (enrollment) to end of treatment, up to 6 weeks | Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of consecutive activities completed at baseline and post-trial. |
| Duration of Sustained Activity Engagement | Baseline (enrollment) to end of treatment, up to 6 weeks | Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the duration of sustained activity engagement at baseline and post-trial. |
| Number of Prompts to Complete Activities | Baseline (enrollment) to end of treatment, up to 6 weeks | Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of prompts needed to complete activities at baseline and post-trial. |
Countries
United States
Contacts
Primary ContactAlice Shillingsburg, PhD, BCBA-D
Backup ContactEmily Sullivan, PhD, BCBA-D
Outcome results
None listed