Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children (NCT06472115) | Clinical Trial Compass
RecruitingNot Applicable
Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
United States30 participantsStarted 2025-01-05
Plain-language summary
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
Who can participate
Age range
6 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6:0 to 10:11 years at the time of consent
* diagnosed with ASD (based on history, review of available medical records including diagnostic testing completed by psychologist)
* IQ \> or = 75 (based on history, review of available medical records)
* report three or more family accommodations for insistence on sameness based on screening measures
* English-speaking parent and youth able to consistently participate in study procedures
Exclusion Criteria:
* children with significant hearing, language or motor impairment
* unstable behavioral and pharmacological treatments (e.g., anxiety medication) to treat anxiety or IS behaviors prior to two months to the start of the study and no anticipated changes in treatments during the course of the trial
* caregivers who have participated in formal SPACE training
* concurrent psychosocial treatment for anxiety or Insistence on Sameness
* children who have a history of prominent school refusal, self-harm, or suicidal ideation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
Timeframe: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up
2
Change from baseline in clinician rated clinical global impressions scale scores during treatment.