跳至主要内容
临床试验/NCT07185737
NCT07185737进行中(未招募)不适用

Cultural Adaptation of Parent Training Intervention for Spanish-Speaking Families

Baylor University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Change in treatment acceptability and satisfaction measured by the Scale of Treatment Perceptions (STP)

研究概览

简要总结

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.

详细描述

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:

  1. Determine whether the adapted program reduces children's challenging behaviors.
  2. Assess changes in caregiver stress, confidence, and knowledge of behavior strategies.
  3. Examine caregiver perceptions of cultural relevance and satisfaction with the program.
  4. Identify barriers and facilitators to program implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

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.

干预措施: Adapted RUBI-Telehealth (Behavioral)

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).

结局指标

主要结局

Change in treatment acceptability and satisfaction measured by the Scale of Treatment Perceptions (STP)

时间窗: 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).

Change in challenging behaviors measured by the Home Situations Questionnaire-ASD (HSQ-ASD)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • Implementation outcomes of adapted RUBI program (12-item measure)(T3 (maintenance, ~16 weeks after baseline, following waitlist intervention))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gospel Kim

Assistant Professor

Baylor University

研究点 (1)

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