Autism Spectrum DisorderNCT06472115
Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS) in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2025to 1 Oct 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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
Stanford University
Stanford, California, 94305
Kari Berquist, PhD, (650) 724-6026, spacestudy@stanford.edu
About this study
Official title: A Pilot Telehealth Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)
- Keywords
- Supportive Parenting for Anxious Childhood emotions (SPACE), Restricted Behavior
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)Behavioural
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism. This includes a 16 week protocol where caregivers meet weekly for one hour with a study therapist.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness Receives: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
DARB scores measure restricted and repetitive behaviors with higher scores indicating greater intensity.
Measured: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up
Change from baseline in clinician rated clinical global impressions scale scores during treatment.
Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment.
Measured: Weeks 8, 16 and 2 month follow up
Secondary outcomes (4)
Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).
ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. [Score Range: 0-72]
Measured: Baseline, Week 16 and 2 month Follow up
Change in Emotion Regulation Checklist scores during treatment
The Emotion Regulation Checklist (ERC) is a 24-item measure of children's self-regulation completed by a caregiver. Items are rated along a continuum (1=rarely, 4=almost always). Higher scores on the Lability/Negativity sub scale indicate more difficulty managing and coping with emotions, while higher scores on the Emotion Regulation sub scale indicate better ability to self-regulate.
Measured: Baseline, 16 week
Change in Daily Living Skills Scale Scores during treatment
Higher scores indicate better ability on the DLSS. [Score Range: 0-53]
Measured: Baseline, 16 week, 2 month Follow up
Change in Open Source - Challenging Behavior scores during treatment
Higher levels indicate greater levels of challenging behavior and lower levels indicate improvement.
Measured: Baseline, 16 weeks, 2 month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start5 Jan 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Phillips, Stanford University
- Investigators
- Jennifer Phillips, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472115
- Sponsor's protocol ID
- IRB-73366
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Telehealth Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
- ClinicalTrials.gov ID
- NCT06472115
- Acronym / sponsor ID
- IRB-73366
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Supportive Parenting for Anxious Childhood emotions (SPACE), Restricted Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Jun 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism. This includes a 16 week protocol where caregivers meet weekly for one hour with a study therapist. | Behavioural | Active treatment |
Primary outcome
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
Time frame: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up
DARB scores measure restricted and repetitive behaviors with higher scores indicating greater intensity.
Change from baseline in clinician rated clinical global impressions scale scores during treatment.
Time frame: Weeks 8, 16 and 2 month follow up
Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment.
4 secondary outcomes
Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).
Time frame: Baseline, Week 16 and 2 month Follow up
Change in Emotion Regulation Checklist scores during treatment
Time frame: Baseline, 16 week
Change in Daily Living Skills Scale Scores during treatment
Time frame: Baseline, 16 week, 2 month Follow up
Change in Open Source - Challenging Behavior scores during treatment
Time frame: Baseline, 16 weeks, 2 month Follow Up
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 25 Feb 2026.
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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.
Jennifer Phillips, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS) in people with Autism Spectrum Disorder and Autism, run by Stanford University 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 5 inclusion and 5 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 25 Feb 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 Kari Berquist, PhD ((650) 724-6026, spacestudy@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment. (time frame: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.