Empowering Caregivers to Promote Child Independence

NCT07059364 | Recruiting

• 2 other identifiers: 0708-24-FBPRO-25-006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Profound Autism; Picture-Based Activity Schedules; Caregiver Training

Outcome Measures

Primary Outcomes (4)

• Number of Participant Accrued

  Number of caregivers who accept random assignment as determined by refusal rate of eligible participants.

  Until accrual is complete, approximately 1 year

• Rate of Participant Attrition

  Participant attrition rate will be determined over the course of the study.

  Up to 6 weeks

• 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.

  Up to 6 weeks

• 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.

  Up to 6 weeks

Secondary Outcomes (7)

• Total Number of Activities Completed

  Baseline (enrollment) to end of treatment, up to 6 weeks

• Number of Consecutive Activities Completed

  Baseline (enrollment) to end of treatment, up to 6 weeks

• Duration of Sustained Activity Engagement

  Baseline (enrollment) to end of treatment, up to 6 weeks

• Number of Prompts to Complete Activities

  Baseline (enrollment) to end of treatment, up to 6 weeks

• Number of Redirections to Stay on Task

  Baseline (enrollment) to end of treatment, up to 6 weeks

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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

Caregiver Activity Schedules Treatment

EXPERIMENTAL

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.

Behavioral: CAST Treatment

Interventions

CAST Treatment BEHAVIORAL

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.

Caregiver Activity Schedules Treatment

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known serious medical condition or serious behavioral/psychiatric condition requiring immediate alternative focused intervention

Sponsors & Collaborators

• University of Nebraska: lead
• Autism Science Foundation: collaborator

Study Sites (1)

Munroe-Meyer Insitute University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

RECRUITING

Related Publications (23)

• 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 BACKGROUND

• 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. doi: 10.1001/jama.2015.3150.

  PMID: 25898050 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• Koyama T, Wang HT. Use of activity schedule to promote independent performance of individuals with autism and other intellectual disabilities: a review. Res Dev Disabil. 2011 Nov-Dec;32(6):2235-42. doi: 10.1016/j.ridd.2011.05.003. Epub 2011 Jun 6.

  PMID: 21645988 BACKGROUND

• Lequia J, Machalicek W, Rispoli MJ. Effects of activity schedules on challenging behavior exhibited in children with autism spectrum disorders: A systematic review. Res Autism Spectr Disord. 2012;6(1); 480- 492. doi: 10.1016/j.rasd.2011.07.008

  BACKGROUND

• . Cho S, Noor NHBM, Sonoyama S. A review of activity schedules for individuals with autism spectrum disorder. J of Spec Educ Resear. 2017;5(2):65-76. doi:10.6033/specialeducation.5.65

  BACKGROUND

• Cavalari RN, Romanczyk RG. Caregiver perspectives on unintentional injury risk in children with an autism spectrum disorder. J Pediatr Nurs. 2012 Dec;27(6):632-41. doi: 10.1016/j.pedn.2011.07.013. Epub 2011 Sep 13.

  PMID: 23101727 BACKGROUND

• Knight V, Sartini E, Spriggs AD. Evaluating visual activity schedules as evidence-based practice for individuals with autism spectrum disorders. J Autism Dev Disord. 2015 Jan;45(1):157-78. doi: 10.1007/s10803-014-2201-z.

  PMID: 25081593 BACKGROUND

• Lang R., O'Reilly M, Rispoli M, Shogren K., Machalicek W, Sigafoos J, Regester A. Review of interventions to increase functional and symbolic play in children with autism. Educ and Train in Dev Disab. 2009;44;481-492. https://www.jstor.org/stable/24234257

  BACKGROUND

• Schwartz IS, Kelly EM. Quality of life for people with disabilities: Why applied behavior analysts should consider this a primary dependent variable. Resear and Pract Severe Disabil. 2021;46(3);159-172. doi.org/10.1177/15407969211033629

  BACKGROUND

• Edwards CK, Landa RK, Frampton SE, Shillingsburg MA. Increasing Functional Leisure Engagement for Children With Autism Using Backward Chaining. Behav Modif. 2018 Jan;42(1):9-33. doi: 10.1177/0145445517699929. Epub 2017 May 3.

  PMID: 28466648 BACKGROUND

• Celia T, Freysteinson W, Fredland N, Bowyer P. Battle weary/battle ready: A phenomenological study of parents' lived experiences caring for children with autism and their safety concerns. J Adv Nurs. 2020 Jan;76(1):221-233. doi: 10.1111/jan.14213. Epub 2019 Oct 27.

  PMID: 31566790 BACKGROUND

• Vaz S, Thomson A, Cuomo B, Falkmer T, Chamberlain A, Black MH. Co-occurring intellectual disability and autism: Associations with stress, coping, time use, and quality of life in caregivers. Research in ASD. 2021; 84;101765. doi.org/10.1016/j.rasd.2021.101765

  BACKGROUND

• Marsack-Topolewski CN, Church HL. Impact of Caregiver Burden on Quality of Life for Parents of Adult Children With Autism Spectrum Disorder. Am J Intellect Dev Disabil. 2019 Mar;124(2):145-156. doi: 10.1352/1944-7558-124.2.145.

  PMID: 30835531 BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Lord C, Charman T, Havdahl A, Carbone P, Anagnostou E, Boyd B, Carr T, de Vries PJ, Dissanayake C, Divan G, Freitag CM, Gotelli MM, Kasari C, Knapp M, Mundy P, Plank A, Scahill L, Servili C, Shattuck P, Simonoff E, Singer AT, Slonims V, Wang PP, Ysrraelit MC, Jellett R, Pickles A, Cusack J, Howlin P, Szatmari P, Holbrook A, Toolan C, McCauley JB. The Lancet Commission on the future of care and clinical research in autism. Lancet. 2022 Jan 15;399(10321):271-334. doi: 10.1016/S0140-6736(21)01541-5. Epub 2021 Dec 6. No abstract available.

  PMID: 34883054 BACKGROUND

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  PMID: 37074176 BACKGROUND

Study Officials

• Alice Shillingsburg, PhD, BCBA-D

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Shillingsburg, PhD, BCBA-D

CONTACT

402-559-3098; ashillingsburg@unmc.edu

Emily Sullivan, PhD, BCBA-D

CONTACT

402-559-8863; esullivan@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 10, 2025
• Study Start: July 15, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: October 1, 2025
• Access Criteria: All IPD and supporting information will be availabile in the open science data repository the National Database for Autism Research (NDAR)

Locations

US (1)