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临床试验/NCT07025603
NCT07025603已完成不适用

Pilot Evaluation of the Social ABCs Parent-Mediated Intervention for Autistic Toddlers in Israel

Hebrew University of Jerusalem2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Feasibility and Acceptability of the Social ABCs Protocol

研究概览

简要总结

The goal of this study is to evaluate the effectiveness of the Social ABCs program for young autistic children and their parents. The study will also explore predictors of treatment success and child outcomes.

The main questions it aims to answer are:

  • Does the Social ABCs program help children use more words and communicate better?
  • Does the program help parents feel more confident and less stressed?
  • Which children and parents benefit most from the program?

Participants will:

  • Join a 6-week Social ABCs program with weekly group and individual coaching sessions
  • Complete assessments before and after the program to see how their child and family are doing
  • Take part in short video-recorded play sessions to see how communication changes over time

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Months 至 40 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children who met diagnostic criteria for autism according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), established by independent gold-standard assessments by both a psychologist and a physician (i.e., child psychiatrist, developmental pediatrician, or child neurologist)
  • diagnosis received before 30 months of age.
  • full-term birth (36-42 weeks gestation) with birth weight >2500 grams

排除标准

  • identifiable neurological, genetic, or severe sensory/motor conditions
  • attending a special education kindergarten
  • participating in a concurrent parent-mediated intervention.

结局指标

主要结局

Feasibility and Acceptability of the Social ABCs Protocol

时间窗: immediately after the intervention

Feasibility will be assessed by tracking recruitment rates, retention throughout the 6-week program, and attendance at both group and individual coaching sessions. Acceptability will be evaluated through parent-reported satisfaction surveys completed at the end of the program, as well as qualitative feedback on the format, content, and delivery of the intervention.

The Hebrew Communicative Development Inventory (HCDI).

时间窗: Baseline (pre-intervention); 6 weeks post-intervention

The HCDI is the adapted Hebrew version of the MacArthur Communicative Development Inventory (MCDI). The MCDI is a well normed, reliable, and valid tool for vocabulary assessment (Bates et al., 1994). The HCDI is a reliable and sensitive measure of lexical development and emergent grammar, capturing wide variability among Israeli toddlers (Maital et al., 2000). We utilized two versions of the inventory: Words \& Gestures for toddlers up to 25 months and Words \& Sentences for children 25 months and older. This questionnaire relies on caregiver report to assess children's receptive and expressive vocabulary, speech comprehension, gesture use, morpheme acquisition, and syntactic complexity. In our study, we focused on two variables: receptive vocabulary total score and expressive vocabulary total score

Parenting Stress Index Short Form (PSI-SR).

时间窗: Baseline (pre-intervention); 6 weeks post-intervention

The PSI-SR is a self-report, 36-item index of parenting-related stress. Each item is scored on a 5-point Likert-type scale, with higher scores indicating greater parenting stress (range 36-180). Alongside a total stress score, the three subscale scores are derived, each composed of 12 items (range 12-60): parental distress (PD), measuring distress caused by the burdens and restrictions of childcare and personal stressors (e.g., depression, conflict with partner); parent-child dysfunctional interaction (PCDI), assessing parents' negative perception of their interactions with the child and the degree to which the child does not meet their expectations; and difficult child (DC), measuring parents' views of the child's self-regulatory functioning. It also includes a defensive responding scale (DR; seven items, range 7-35), which assesses if the parent is trying to deny or minimize problems.

次要结局

  • Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2; Lord et al., 2012).(Baseline (pre-intervention); 6 weeks post-intervention)
  • The Mullen Scales of Early Learning (MSEL; Mullen, 1995).(Baseline (pre-intervention); 6 weeks post-intervention)
  • Adaptive Behavior Assessment System-Second Edition Parent Form, Ages 0-5 (ABAS-II; Harrison & Oakland, 2000).(Baseline (pre-intervention); 6 weeks post-intervention)
  • Aberrant Behavior Checklist (ABC; Aman et al., 1985; Kaat et al., 2014).(Baseline (pre-intervention); 6 weeks post-intervention)
  • Communication and Symbolic Behavior Scales Developmental Profile (CSBS-DP) Infant-Toddler Checklist(Baseline (pre-intervention); 6 weeks post-intervention)
  • Social ABCs Satisfaction Questionnaire (Brian et al., 2016).(immediately after the intervention)

研究者

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

Judah Koller

Assistant Professor, Clinical Child Psychology and Special Education

Hebrew University of Jerusalem

研究点 (2)

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