Culturally Adapted RUBI-T for Spanish-Speaking Families in Texas and Mexico

NCT07185737 | Not Yet Recruiting DMC

• 1 other identifier: 2297844-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Autism

Keywords

Autism; Cultural Adaptation; RUBI-T; Behavior Parent Training

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  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)

  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)

  T3 (maintenance, ~16 weeks after baseline, following waitlist intervention)

Other Outcomes (1)

• Caregiver perceptions of cultural relevance, feasibility, and barriers to implementation

  Post-intervention (T2, ~8 weeks) and Maintenance (T3, ~16 weeks)

Study Arms (2)

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.

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).

Interventions

Adapted RUBI-Telehealth BEHAVIORAL

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.

Adapted RUBI-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Prior participation in the Research Units in Behavioral Intervention (RUBI) program.
• Caregiver does not speak Spanish.
• Caregiver unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Baylor University: lead
• University of Texas Rio Grande Valley: collaborator

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Gospel Y Kim, Ph.D.

CONTACT

626-329-6989; gospel_kim@baylor.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 22, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)