AutismSS RUBINCT07185737
Culturally Adapted RUBI for Spanish-Speaking Families in Texas and Mexico
A study testing Adapted RUBI-Telehealth in people with Autism, run by Baylor University at 1 site in United States.
Trial summary
Supporting young autistic children can sometimes be very stressful, especially when children show behaviors that are difficult to understand and/or manage in everyday life. Research has shown that teaching parents practical strategies through programs like the Research Units in Behavioral Intervention (RUBI) can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism
- What is being tested?
- Adapted RUBI-Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2025to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver of a child aged 2 to 9 years.
- Caregiver of a child diagnosed with autism or suspected of being autistic.
- Child exhibits challenging behaviors in naturalistic environments (e.g., home, school, community).
- Caregiver is willing to complete all aspects of the study, including assessments and intervention sessions.
- Caregiver has access to electronic resources (e.g., high-speed internet and a device capable of participating in Zoom sessions).
- Caregiver is fluent in Spanish (speaks and understands Spanish sufficiently to participate in the intervention and assessments).
Who cannot join
- Prior participation in the Research Units in Behavioral Intervention (RUBI) program.
- Caregiver does not speak Spanish.
- Caregiver unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Adaptation of Parent Training Intervention for Spanish-Speaking Families
Supporting young autistic children can sometimes be very stressful, especially when children show behaviors that are difficult to understand and/or manage in everyday life. Research has shown that teaching parents practical strategies through programs like the Research Units in Behavioral Intervention (RUBI) can reduce these behaviors and help parents feel more confident. However, most of these programs have only been studied with English-speaking families, which means Spanish-speaking caregivers often do not have access to support that feels relevant to their culture and language.
This study will test a version of RUBI that has been adapted for Spanish-speaking families in the U.S. and Mexico. We will invite 100 parents of autistic children between the ages of 2 and 9 to take part. Half will start the program right away, while the other half will wait and receive it later. Parents in the program will join eight online group sessions, use a Spanish handbook at home, and practice strategies with support from trained facilitators.
Read more
We will look at whether the program helps reduce children's challenging behaviors, lowers parent stress, and increases parents' confidence in managing behaviors. We will also ask parents to share their experiences and opinions about how well the program fits their culture and daily life.
By combining numbers (surveys) and stories (interviews), this project will show whether the adapted program works well for Spanish-speaking families. The results can help make autism services more fair, accessible, and supportive for families from diverse backgrounds.
Read the detailed description
Background and Rationale Challenging behaviors in young autistic children can negatively affect their quality of life and increase stress for caregivers. Behavioral Parent Training (BPT) programs, such as the Research Units in Behavioral Intervention (RUBI), have demonstrated strong evidence for reducing child behavior difficulties and improving parenting outcomes. However, most studies have been conducted with White, English-speaking families, limiting generalizability to diverse communities. Spanish-speaking families in the United States and Mexico often experience limited access to culturally responsive interventions, creating disparities in autism care.
Cultural adaptation is a systematic approach to tailoring interventions to better align with the values, language, and lived experiences of target populations. Research indicates that culturally adapted interventions can improve both child and caregiver outcomes, but adaptation practices are inconsistently reported. Adapting RUBI for Spanish-speaking caregivers has the potential to increase its accessibility and effectiveness for an underserved group.
Objectives
This study aims to evaluate the effectiveness, feasibility, and cultural acceptability of an adapted RUBI program for Spanish-speaking caregivers of autistic children. The specific objectives are to:
- Determine whether the adapted program reduces children's challenging behaviors.
- Assess changes in caregiver stress, confidence, and knowledge of behavior strategies.
- Examine caregiver perceptions of cultural relevance and satisfaction with the program.
- Identify barriers and facilitators to program implementation.
Study Design This study uses a convergent mixed-methods design combining a pilot randomized controlled trial (RCT) with qualitative data collection. A total of 100 caregivers will be randomly assigned to either (a) the immediate intervention group or (b) the waitlist control group, who will receive the intervention after the initial study period.
Participants and Recruitment Caregivers will be recruited through community organizations, autism advocacy groups, ABA clinics, and online platforms serving Spanish-speaking families. Eligible participants must (a) be a caregiver of a child aged 2-9 years diagnosed with or suspected of autism, (b) report child challenging behaviors in everyday settings, (c) be Spanish-speaking, and (d) have access to internet and a device for online participation. Exclusion criteria include prior experience with RUBI.
Recruitment, consent, and baseline data collection will occur online. Participants will be enrolled beginning September 2025, with intervention delivery from September-November 2025 (intervention group) and January-March 2026 (waitlist control).
Intervention
The intervention is an eight-session, virtually delivered version of RUBI, culturally adapted for Spanish-speaking families. Parents will:
(a) Attend weekly group sessions via Zoom led by trained behavioral therapists; (b) Use a Spanish-language RUBI handbook for guided practice at home; (c) Engage in role-play, modeling, and practice with feedback based on behavioral skills training.
Outcomes Quantitative measures will include: (a) RUBI Parent Confidence Scale (PCS), (b) Home Situations Questionnaire-ASD (HSQ-ASD), (c) Caregiver Knowledge Assessment (CKA), (d) Scale of Treatment Perceptions (STP), (e) Autism Parent Stress Index (APSI), and (f) Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Qualitative data will be collected through post-intervention open-ended responses and optional focus groups in Spanish, focusing on feasibility, satisfaction, and cultural relevance.
Analysis Plan Quantitative data will be analyzed using repeated measures ANOVA with time (pre vs. post) as a within-subject factor and condition (intervention vs. control) as a between-subject factor. Post hoc tests and Cohen's d will estimate effect sizes. Qualitative data will undergo rapid analysis by bilingual coders to identify themes related to program benefits, cultural fit, and implementation barriers. Triangulation across survey, focus group, and observational data will be used to strengthen findings.
- Conditions
- Autism
- Being tested
- Adapted RUBI-Telehealth
- Keywords
- Autism, Cultural Adaptation, RUBI-T, Behavior Parent Training
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted RUBI-TelehealthBehavioural
The Adapted RUBI Parent Training is a culturally tailored version of the Research Units in Behavioral Intervention (RUBI) program, designed for Spanish-speaking caregivers of young autistic children. The intervention consists of 8 weekly sessions delivered virtually in Spanish by trained behavioral therapists. Each session incorporates behavioral skills training methods (instruction, modeling, role-play, and feedback). Caregivers use a Spanish-language RUBI handbook to complete weekly home practice activities and receive feedback during sessions. The program focuses on helping caregivers understand the functions of challenging behavior and apply evidence-based strategies to reduce these behaviors and promote positive child outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Adapted RUBI-T | Experimental | Caregivers randomized to this arm will immediately participate in the culturally adapted Research Units in Behavioral Intervention (RUBI) program. The intervention consists of 8 weekly group sessions delivered virtually in Spanish by trained behavioral therapists. Caregivers will also use a Spanish-language RUBI parent handbook to complete home practice assignments and will receive guided feedback and coaching during sessions. Receives: Behavioral: Adapted RUBI-Telehealth |
| Waitlist Control Arm | No intervention | Spanish-speaking caregivers are placed on a waitlist and continue with usual care during the initial study period. After the intervention group completes the program, waitlist participants receive the same adapted RUBI program (8 weekly online sessions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in challenging behaviors measured by the Home Situations Questionnaire-ASD (HSQ-ASD)
The HSQ-ASD (Chowdhury et al., 2016) is a 24-item caregiver-report tool assessing severity of challenging behaviors in children with autism across daily situations. Higher scores indicate more severe problem behaviors.
Measured: Baseline (T1, pre-intervention), Post-intervention (T2, ~8 weeks after baseline), and Maintenance (T3, ~16 weeks after baseline, following waitlist group intervention)
Change in caregiver confidence measured by the RUBI Parent Confidence Scale (PCS)
The PCS is a 12-item measure of caregiver confidence in applying behavioral strategies from the RUBI program. Scores range from 1-3, with higher scores indicating greater confidence.
Measured: T1 (baseline), T2 (~8 weeks), and T3 (~16 weeks)
Change in caregiver knowledge measured by the Caregiver Knowledge Assessment (CKA)
The CKA (Lee et al., 2022) is a 28-item multiple-choice assessment of caregiver knowledge of behavioral parent training strategies. Higher scores reflect greater knowledge.
Measured: T1 (baseline), T2 (~8 weeks), and T3 (~16 weeks)
Change in treatment acceptability and satisfaction measured by the Scale of Treatment Perceptions (STP)
The STP (Berger et al., 2016) uses a 7-point Likert scale to assess acceptability, anticipated outcomes (T1), and satisfaction with the program (T2, T3).
Measured: T1 (baseline, anticipated outcomes), T2 (~8 weeks, satisfaction), and T3 (~16 weeks, maintenance satisfaction)
Secondary outcomes (2)
Change in caregiver stress measured by the Autism Parenting Stress Index (APSI)
The APSI is a caregiver-report questionnaire that measures stress related to parenting a child with autism, focusing on areas such as social communication, challenging behaviors, and daily care. Higher scores indicate higher parenting stress.
Measured: T1 (baseline, pre-intervention), T2 (post-intervention, ~8 weeks), and T3 (maintenance, ~16 weeks after baseline, following waitlist intervention)
Implementation outcomes of adapted RUBI program (12-item measure)
A 12-item implementation outcome measure will be used to assess caregiver perceptions of feasibility, acceptability, appropriateness, and intention to use the strategies taught in the adapted RUBI program. Items are scored on a Likert scale, with higher scores reflecting more favorable implementation outcomes.
Measured: T3 (maintenance, ~16 weeks after baseline, following waitlist intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start25 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- 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 one of two arms: (1) intervention arm, where caregivers immediately receive the culturally adapted RUBI program, or (2) waitlist control arm, where caregivers receive the same intervention after the first group completes the program.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Rio Grande Valley
- Responsible party
- Principal investigator, Gospel Kim, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185737
- Sponsor's protocol ID
- 2297844-2
- Acronym
- SS RUBI
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team has not yet determined whether de-identified individual participant data (IPD) will be shared. Decisions will depend on IRB guidance, funding agency requirements, and feasibility of preparing anonymized datasets while maintaining participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation of Parent Training Intervention for Spanish-Speaking Families
- ClinicalTrials.gov ID
- NCT07185737
- Acronym / sponsor ID
- SS RUBI / 2297844-2
- Conditions
- Autism
- Keywords
- Autism, Cultural Adaptation, RUBI-T, Behavior Parent Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- University of Texas Rio Grande Valley
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 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.
Supporting young autistic children can sometimes be very stressful, especially when children show behaviors that are difficult to understand and/or manage in everyday life. Research has shown that teaching parents practical strategies through programs like the Research Units in Behavioral Intervention (RUBI) can reduce these behaviors and help parents feel more confident. However, most of these programs have only been studied with English-speaking families, which means Spanish-speaking caregivers often do not have access to support that feels relevant to their culture and language.
This study will test a version of RUBI that has been adapted for Spanish-speaking families in the U.S. and Mexico. We will invite 100 parents of autistic children between the ages of 2 and 9 to take part. Half will start the program right away, while the other half will wait and receive it later. Parents in the program will join eight online group sessions, use a Spanish handbook at home, and practice strategies with support from trained facilitators.
We will look at whether the program helps reduce children's challenging behaviors, lowers parent stress, and increases parents' confidence in managing behaviors. We will also ask parents to share their experiences and opinions about how well the program fits their culture and daily life.
By combining numbers (surveys) and stories (interviews), this project will show whether the adapted program works well for Spanish-speaking families. The results can help make autism services more fair, accessible, and supportive for families from diverse backgrounds.
Detailed description
Background and Rationale Challenging behaviors in young autistic children can negatively affect their quality of life and increase stress for caregivers. Behavioral Parent Training (BPT) programs, such as the Research Units in Behavioral Intervention (RUBI), have demonstrated strong evidence for reducing child behavior difficulties and improving parenting outcomes. However, most studies have been conducted with White, English-speaking families, limiting generalizability to diverse communities. Spanish-speaking families in the United States and Mexico often experience limited access to culturally responsive interventions, creating disparities in autism care.
Cultural adaptation is a systematic approach to tailoring interventions to better align with the values, language, and lived experiences of target populations. Research indicates that culturally adapted interventions can improve both child and caregiver outcomes, but adaptation practices are inconsistently reported. Adapting RUBI for Spanish-speaking caregivers has the potential to increase its accessibility and effectiveness for an underserved group.
Objectives
This study aims to evaluate the effectiveness, feasibility, and cultural acceptability of an adapted RUBI program for Spanish-speaking caregivers of autistic children. The specific objectives are to:
- Determine whether the adapted program reduces children's challenging behaviors.
- Assess changes in caregiver stress, confidence, and knowledge of behavior strategies.
- Examine caregiver perceptions of cultural relevance and satisfaction with the program.
- Identify barriers and facilitators to program implementation.
Study Design This study uses a convergent mixed-methods design combining a pilot randomized controlled trial (RCT) with qualitative data collection. A total of 100 caregivers will be randomly assigned to either (a) the immediate intervention group or (b) the waitlist control group, who will receive the intervention after the initial study period.
Participants and Recruitment Caregivers will be recruited through community organizations, autism advocacy groups, ABA clinics, and online platforms serving Spanish-speaking families. Eligible participants must (a) be a caregiver of a child aged 2-9 years diagnosed with or suspected of autism, (b) report child challenging behaviors in everyday settings, (c) be Spanish-speaking, and (d) have access to internet and a device for online participation. Exclusion criteria include prior experience with RUBI.
Recruitment, consent, and baseline data collection will occur online. Participants will be enrolled beginning September 2025, with intervention delivery from September-November 2025 (intervention group) and January-March 2026 (waitlist control).
Intervention
The intervention is an eight-session, virtually delivered version of RUBI, culturally adapted for Spanish-speaking families. Parents will:
(a) Attend weekly group sessions via Zoom led by trained behavioral therapists; (b) Use a Spanish-language RUBI handbook for guided practice at home; (c) Engage in role-play, modeling, and practice with feedback based on behavioral skills training.
Outcomes Quantitative measures will include: (a) RUBI Parent Confidence Scale (PCS), (b) Home Situations Questionnaire-ASD (HSQ-ASD), (c) Caregiver Knowledge Assessment (CKA), (d) Scale of Treatment Perceptions (STP), (e) Autism Parent Stress Index (APSI), and (f) Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Qualitative data will be collected through post-intervention open-ended responses and optional focus groups in Spanish, focusing on feasibility, satisfaction, and cultural relevance.
Analysis Plan Quantitative data will be analyzed using repeated measures ANOVA with time (pre vs. post) as a within-subject factor and condition (intervention vs. control) as a between-subject factor. Post hoc tests and Cohen's d will estimate effect sizes. Qualitative data will undergo rapid analysis by bilingual coders to identify themes related to program benefits, cultural fit, and implementation barriers. Triangulation across survey, focus group, and observational data will be used to strengthen findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two arms: (1) intervention arm, where caregivers immediately receive the culturally adapted RUBI program, or (2) waitlist control arm, where caregivers receive the same intervention after the first group completes the program.
| Arm | Type | Receives |
|---|---|---|
| Adapted RUBI-T | Experimental | Behavioral: Adapted RUBI-TelehealthCaregivers randomized to this arm will immediately participate in the culturally adapted Research Units in Behavioral Intervention (RUBI) program. The intervention consists of 8 weekly group sessions delivered virtually in Spanish by trained behavioral therapists. Caregivers will also use a Spanish-language RUBI parent handbook to complete home practice assignments and will receive guided feedback and coaching during sessions. |
| Waitlist Control Arm | No intervention | –Spanish-speaking caregivers are placed on a waitlist and continue with usual care during the initial study period. After the intervention group completes the program, waitlist participants receive the same adapted RUBI program (8 weekly online sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caregiver of a child aged 2 to 9 years.
- Caregiver of a child diagnosed with autism or suspected of being autistic.
- Child exhibits challenging behaviors in naturalistic environments (e.g., home, school, community).
- Caregiver is willing to complete all aspects of the study, including assessments and intervention sessions.
- Caregiver has access to electronic resources (e.g., high-speed internet and a device capable of participating in Zoom sessions).
Key exclusion criteria (3 listed)
- Prior participation in the Research Units in Behavioral Intervention (RUBI) program.
- Caregiver does not speak Spanish.
- Caregiver unable or unwilling to provide informed consent.
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 |
|---|---|---|
| Adapted RUBI-TelehealthThe Adapted RUBI Parent Training is a culturally tailored version of the Research Units in Behavioral Intervention (RUBI) program, designed for Spanish-speaking caregivers of young autistic children. The intervention consists of 8 weekly sessions delivered virtually in Spanish by trained behavioral therapists. Each session incorporates behavioral skills training methods (instruction, modeling, role-play, and feedback). Caregivers use a Spanish-language RUBI handbook to complete weekly home practice activities and receive feedback during sessions. The program focuses on helping caregivers understand the functions of challenging behavior and apply evidence-based strategies to reduce these behaviors and promote positive child outcomes. | Behavioural | Adapted RUBI-T |
Primary outcome
Change in challenging behaviors measured by the Home Situations Questionnaire-ASD (HSQ-ASD)
Time frame: Baseline (T1, pre-intervention), Post-intervention (T2, ~8 weeks after baseline), and Maintenance (T3, ~16 weeks after baseline, following waitlist group intervention)
The HSQ-ASD (Chowdhury et al., 2016) is a 24-item caregiver-report tool assessing severity of challenging behaviors in children with autism across daily situations. Higher scores indicate more severe problem behaviors.
Change in caregiver confidence measured by the RUBI Parent Confidence Scale (PCS)
Time frame: T1 (baseline), T2 (~8 weeks), and T3 (~16 weeks)
The PCS is a 12-item measure of caregiver confidence in applying behavioral strategies from the RUBI program. Scores range from 1-3, with higher scores indicating greater confidence.
Change in caregiver knowledge measured by the Caregiver Knowledge Assessment (CKA)
Time frame: T1 (baseline), T2 (~8 weeks), and T3 (~16 weeks)
The CKA (Lee et al., 2022) is a 28-item multiple-choice assessment of caregiver knowledge of behavioral parent training strategies. Higher scores reflect greater knowledge.
Change in treatment acceptability and satisfaction measured by the Scale of Treatment Perceptions (STP)
Time frame: T1 (baseline, anticipated outcomes), T2 (~8 weeks, satisfaction), and T3 (~16 weeks, maintenance satisfaction)
The STP (Berger et al., 2016) uses a 7-point Likert scale to assess acceptability, anticipated outcomes (T1), and satisfaction with the program (T2, T3).
2 secondary outcomes
Change in caregiver stress measured by the Autism Parenting Stress Index (APSI)
Time frame: T1 (baseline, pre-intervention), T2 (post-intervention, ~8 weeks), and T3 (maintenance, ~16 weeks after baseline, following waitlist intervention)
Implementation outcomes of adapted RUBI program (12-item measure)
Time frame: T3 (maintenance, ~16 weeks after baseline, following waitlist intervention)
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 3 Aug 2026.
- Individual participant dataSharing planned: Undecided. The research team has not yet determined whether de-identified individual participant data (IPD) will be shared. Decisions will depend on IRB guidance, funding agency requirements, and feasibility of preparing anonymized datasets while maintaining participant confidentiality.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted RUBI-Telehealth in people with Autism, run by Baylor 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in challenging behaviors measured by the Home Situations Questionnaire-ASD (HSQ-ASD) (time frame: Baseline (T1, pre-intervention), Post-intervention (T2, ~8 weeks after baseline), and Maintenance (T3, ~16 weeks after baseline, following waitlist group intervention)). 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?
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 3 Aug 2026.