Profound AutismNCT07059364
Empowering Caregivers to Promote Child Independence
A study testing CAST Treatment in people with Profound Autism, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Profound Autism
- What is being tested?
- CAST Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Known serious medical condition or serious behavioral/psychiatric condition requiring immediate alternative focused intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Munroe-Meyer Insitute University of Nebraska Medical Center
Omaha, Nebraska, 68106
Amanda Oliver, MA, 402-552-3076, aoliver@unmc.edu
Emily Sullivan, PhD, BCBA-D, 402-559-8863, esullivan@unmc.edu
About this study
Official title: Empowering Caregivers to Promote Child Independence and Persistence With Activities
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.
Read the 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).
- Conditions
- Profound Autism
- Being tested
- CAST Treatment
- Keywords
- Profound Autism, Picture-Based Activity Schedules, Caregiver Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAST TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CAST Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Accrued
Number of caregivers who accept random assignment as determined by refusal rate of eligible participants.
Measured: Until accrual is complete, approximately 1 year
Rate of Participant Attrition
Participant attrition rate will be determined over the course of the study.
Measured: 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.
Measured: 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.
Measured: Up to 6 weeks
Secondary outcomes (7)
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.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
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.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
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.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
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.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
Number of Redirections to Stay on Task
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the number of redirections to stay on task at baseline and post-trial.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
Caregiver Proximity to Their Child
Caregiver Activity Schedules Treatment (CAST) activity completion will be evaluated based the caregiver proximity to their child at baseline and post-trial.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
Improvement Ratings on the Clinical Global Impressions - Improvement Scale
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.
Measured: Baseline (enrollment) to end of treatment, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Profound AutismStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Science Foundation
- Responsible party
- Sponsor
- Investigators
- Alice Shillingsburg, PhD, BCBA-D, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059364
- Sponsor's protocol ID
- 0708-24-FB
- Other IDs
- PRO-25-006
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study outcome measures will be shared with the National Database for Autism Reserch. Global Unique Identifiers will be used to share data from the study and all indentifying participant information will be removed before sharing.
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.
PubMed 35093490Bearss 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.
PubMed 25898050Sheridan 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.
PubMed 34213717Hirst 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.
PubMed 37892301Shillingsburg 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.
PubMed 29338313Gordon 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.
PubMed 32953393Shillingsburg 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
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.
PubMed 21645988Lequia 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
. 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
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.
PubMed 23101727Knight 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.
PubMed 25081593Lang 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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Caregivers to Promote Child Independence and Persistence With Activities
- ClinicalTrials.gov ID
- NCT07059364
- Acronym / sponsor ID
- 0708-24-FB
- Conditions
- Profound Autism
- Keywords
- Profound Autism, Picture-Based Activity Schedules, Caregiver Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Autism Science Foundation
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Treatment as Usual (TAU) will consist of 3-6 weeks of continuing usual care. |
| Caregiver Activity Schedules Treatment | Experimental | Behavioral: CAST TreatmentCaregiver 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (1 listed)
- Known serious medical condition or serious behavioral/psychiatric condition requiring immediate alternative focused intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAST TreatmentActivity 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. | Behavioural | Caregiver Activity Schedules Treatment |
Primary outcome
Number of Participant Accrued
Time frame: 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
Time frame: Up to 6 weeks
Participant attrition rate will be determined over the course of the study.
Ratings of Caregiver Activity Schedules Treatment Acceptability
Time frame: 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
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 35093490Scahill 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.
- Background: PubMed 25898050Bearss 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.
- Background: PubMed 34213717Sheridan 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.
- Background: PubMed 37892301Hirst 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.
- Background: PubMed 29338313Shillingsburg 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.
- BackgroundGordon 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: PubMed 32953393Frampton 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.
- BackgroundShillingsburg 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: PubMed 21645988Koyama 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.
- BackgroundLequia 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: PubMed 23101727Cavalari 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.
- Individual participant dataSharing planned: Yes. All study outcome measures will be shared with the National Database for Autism Reserch. Global Unique Identifiers will be used to share data from the study and all indentifying participant information will be removed before sharing.
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Management of Catatonic Features in Adolescents With Profound Autism
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Shillingsburg, PhD, BCBA-D principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAST Treatment in people with Profound Autism, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Shillingsburg, PhD, BCBA-D (402-559-3098, ashillingsburg@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant Accrued (time frame: Until accrual is complete, approximately 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07059364, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.