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临床试验/NCT04505488
NCT04505488已完成不适用

Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Parenting Stress

研究概览

简要总结

The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child is between 18 months through 6 years of age
  • Child has a medical diagnosis or educational classification of Autism or Autism Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F) and/or Social Communication Questionnaire (SCQ)
  • Child resides in a low-resource household as determined by at least one of the following criteria:
  • -Child or family has Medicaid as an insurance provider
  • -Child's primary caregiver has achieved a high school or lower education
  • -Child resides in a household with an annual income of 200% of the Federal Poverty Level

排除标准

  • Primary caregiver does not speak/understand English or Spanish
  • Child is younger 18 months or older than 6 years of age
  • Child does not have a medical diagnosis or educational classification of Autism/ASD or does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ
  • Child does not reside in low-resource household

研究组 & 干预措施

Control Group

No Intervention

The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team.

Intervention Group

Experimental

The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.

干预措施: ASD Screening Parent ENgagement Intervention Program (ASPEN) (Behavioral)

结局指标

主要结局

Parenting Stress

时间窗: Baseline to Follow-Up (24-28 weeks post baseline) Change

Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome

Parent Empowerment

时间窗: Baseline to Follow-Up (24-28 weeks post baseline) Change

Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Adaptive Behavior

时间窗: Baseline to Follow-Up (24-28 weeks post baseline) Change

Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome

Adaptive Behavior

时间窗: Baseline to Post-Intervention (12-14 weeks post baseline) Change

Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome

Parenting Stress

时间窗: Baseline to Post-Intervention (12-14 weeks post baseline) Change

Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome

Parent Empowerment

时间窗: Baseline to Post-Intervention (12-14 weeks post baseline) Change

Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

次要结局

  • Child Challenging Behavior(Baseline to Follow-Up (24-28 weeks post baseline) Change)
  • Family Quality of Life(Baseline to Follow-Up (24-28 weeks post baseline) Change)
  • Child Challenging Behavior(Baseline to Post-Intervention (12-14 weeks post baseline) Change)
  • Family Quality of Life(Baseline to Post-Intervention (12-14 weeks post baseline) Change)

研究者

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

Sandra B. Vanegas

Research Assistant Professor

University of Texas at Austin

研究点 (1)

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