Adapted RUBI-Telehealth for Autism

(SS RUBI-T Trial)

Overseen By Gospel Y Kim, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor University

Disqualifiers: Prior RUBI participation, Non-Spanish speaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Spanish-speaking families by testing a version of the RUBI program, which teaches parents strategies to manage challenging behaviors in young autistic children. The study will involve 100 parents, who will either begin the program immediately or after a short wait. Participants will attend eight online group sessions in Spanish and use a handbook for home practice. The goal is to determine if the program reduces children's challenging behaviors and lowers parent stress. Families with a child aged 2 to 9 who exhibits challenging behaviors and where the caregiver is fluent in Spanish may be well-suited for this trial. As an unphased study, this trial provides families the opportunity to access potentially helpful strategies and support early on.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on teaching strategies to parents rather than involving medication changes.

What prior data suggests that this adapted RUBI-Telehealth program is safe for Spanish-speaking families?

Research shows that participants generally receive the Adapted RUBI-Telehealth program well. Studies have found that parents in similar online behavior training programs reported few, if any, negative effects. These programs are designed to be safe and supportive, focusing on teaching practical skills to help manage children's behaviors at home. Since RUBI is a behavioral program and not a medication, it is less likely to cause side effects like those from drugs. Instead, it aims to provide parents with strategies and support. Overall, the Adapted RUBI-Telehealth program appears to be a safe choice for families seeking to manage challenging behaviors in children with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adapted RUBI-Telehealth program because it offers a culturally tailored approach for Spanish-speaking caregivers of children with autism, which is not commonly available in standard treatments. Unlike traditional in-person behavioral interventions, this program is delivered virtually, making it more accessible for families who may face barriers to attending in-person sessions. Additionally, the program includes a Spanish-language parent handbook, ensuring that caregivers can fully engage with the material and apply the strategies at home, potentially enhancing the overall effectiveness of the intervention.

What evidence suggests that the Adapted RUBI-Telehealth program is effective for Spanish-speaking families with autistic children?

Research has shown that the adapted RUBI-Telehealth program, which participants in this trial may receive, can help reduce difficult behaviors in autistic children and lower stress for their parents. One study found that parents involved in programs like RUBI noticed fewer behavior problems in their children and felt less stressed. These programs also increased parents' confidence in managing their child's behaviors. The RUBI program, when offered through telehealth, has proven effective, especially when adjusted to meet cultural and language needs. Early results suggest this method works well and is welcomed by Spanish-speaking families, making it a promising choice for those seeking help with autism-related challenges. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking parents in the U.S. and Mexico with autistic children aged 2-9 years. It's designed to help those who face challenges managing their child's behaviors due to cultural and language barriers.

Inclusion Criteria

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

Exclusion Criteria

Prior participation in the Research Units in Behavioral Intervention (RUBI) program

Caregiver unable or unwilling to provide informed consent

My caregiver does not speak Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers participate in the culturally adapted RUBI program, attending 8 weekly group sessions delivered virtually in Spanish by trained behavioral therapists.

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for changes in challenging behaviors, caregiver confidence, and stress levels after the intervention.

8 weeks

Maintenance

Continued monitoring of participants to assess long-term effects of the intervention, including caregiver perceptions of cultural relevance and feasibility.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted RUBI-Telehealth

Trial Overview The study tests a culturally adapted telehealth program called RUBI, tailored for Spanish speakers. Parents will participate in eight online sessions, use a handbook, and practice strategies with facilitators to manage their child's behavior.

How Is the Trial Designed?

Group I: Adapted RUBI-T Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Arm Active Control 1 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 Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

University of Texas Rio Grande Valley

Collaborator

Trials

8

Recruited

2,700+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0213616325000308

Telehealth group parent training for children with autism ... Program effectiveness was evaluated using parent-reported measures on their children and on themselves assessing behavior problems, parental stress, and quality ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10177738/

Behavioral Parent Training via Telehealth for Autistic ... RUBI-PT is the first BPT program specifically for parents of children with ASD to be evaluated in a rigorous, randomized-controlled study.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07185737

Culturally Adapted RUBI-T for Spanish-Speaking Families ... This study aims to evaluate the effectiveness, feasibility, and cultural acceptability of an adapted RUBI program for Spanish-speaking ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/10983007231200541

Behavioral Parent Training Via Telehealth for Autistic ... RUBI-T also shows promise for reducing children's disruptive behavior, improving children's adaptive skills, and reducing parent stress, although a more ...

5. psycnet.apa.org psycnet.apa.org/record/2023-92091-001

Adaptation of the research unit on behavioral interventions ... Adaptation of the research unit on behavioral interventions caregiver training program for remote group delivery: Preliminary analysis of clinical outcomes.

6. withpower.com withpower.com/trial/phase-autistic-disorder-8-2025-92d80

Adapted RUBI-Telehealth for Autism · Info for Participants ... Adapted RUBI-Telehealth will have tolerable side effects & efficacy for patients with Autism and Autism Spectrum Disorder. Learn more about the study.

7. humanfactors.jmir.org humanfactors.jmir.org/2024/1/e52295

Mobile App–Assisted Parent Training Intervention for ... We aimed to develop and evaluate the feasibility of a mobile app–assisted parent training program for reducing problem behaviors in children with ASD.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0307273

Feasibility, acceptability, and effects of a web-delivered ... This paper describes an ongoing pilot study examining the feasibility, acceptability, and preliminary effects on caregiver well-being and disruptive child ...