Empowering Caregivers to Promote Child Independence

Official title

Empowering Caregivers to Promote Child Independence and Persistence With Activities

Overview

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

• Behavioral 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 measures

• 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]

Secondary outcome measures (7)

• Total Number of Activities Completed [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]
• Number of Consecutive Activities Completed [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]
• Duration of Sustained Activity Engagement [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]
• Number of Prompts to Complete Activities [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]
• Number of Redirections to Stay on Task [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]
• Caregiver Proximity to Their Child [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]
• Improvement Ratings on the Clinical Global Impressions - Improvement Scale [Time frame: Baseline (enrollment) to end of treatment, up to 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Munroe-Meyer Insitute University of Nebraska Medical Center — Omaha

Publications

• Scahill L, Shillingsburg MA, Ousley O, Pileggi ML, Kilbourne RL, Buckley D, Gillespie SE, McCracken C. A Randomized Trial of Direct Instruction Language for Learning in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2022 Jun;61(6):772-781. doi: 10.1016/j.jaac.2021.11.034. Epub 2022 Jan 31. PMID 35093490
• Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. PMID 25898050
• Sheridan E, Gillespie S, Johnson CR, Lecavalier L, Smith T, Swiezy N, Turner K, Pritchett J, Mruzek DW, Evans AN, Bearss K, Scahill L. Using Parent Target Problem Narratives to Evaluate Outcomes in Children with Autism Spectrum Disorder. Res Child Adolesc Psychopathol. 2021 Nov;49(11):1527-1535. doi: 10.1007/s10802-021-00843-8. Epub 2021 Jul 2. PMID 34213717
• Hirst K, Zamzow RM, Stichter JP, Beversdorf DQ. A Pilot Feasibility Study Assessing the Combined Effects of Early Behavioral Intervention and Propranolol on Autism Spectrum Disorder (ASD). Children (Basel). 2023 Sep 30;10(10):1639. doi: 10.3390/children10101639. PMID 37892301
• Shillingsburg MA, Hansen B, Wright M. Rapport Building and Instructional Fading Prior to Discrete Trial Instruction: Moving From Child-Led Play to Intensive Teaching. Behav Modif. 2019 Mar;43(2):288-306. doi: 10.1177/0145445517751436. Epub 2018 Jan 17. PMID 29338313
• Gordon KR, Shillingsburg MA. Teaching mands for social information to individuals with develop mental disabilities. Adv Neurodev Disord. 2019;3;363-371. doi: 10.1007/s41252-019-00126-w
• Frampton SE, Shillingsburg MA, Simeone PJ. Feasibility and Preliminary Efficacy of Direct Instruction for Individuals With Autism Utilizing Speech-Generating Devices. Behav Anal Pract. 2020 Feb 11;13(3):648-658. doi: 10.1007/s40617-020-00412-3. eCollection 2020 Sep. PMID 32953393
• Shillingsburg MA, Frampton SE, Juban B, Weddle SA, Silva MR. Implementing an applied verbal behavior model in classrooms. Behav Intervent. 2022;37(1), 56-78. doi.org/10.1002/bin.1807

Identifiers

NCT: NCT07059364 · 0708-24-FB · PRO-25-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗