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临床试验/NCT07763067
NCT07763067已完成不适用

Acceptability and Preliminary Clinical Outcomes of an Online Group-Based Parent-Mediated Intervention for Young Autistic Children: A Pre-Post Study From Türkiye

Herguner Therapy Private Clinic1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年10月3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
发起方
入组人数
55
试验地点
1
主要终点
Change in Child Social Communication Assessed by the Social Communication Checklist-Revised (SCC-R)

研究概览

简要总结

This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of an 8-week online group-based parent-mediated intervention (OYNA) for parents of young autistic children. Mothers and fathers independently completed assessments of their child's social communication skills and their own psychological distress at baseline and immediately after the intervention. The study was designed to examine pre-post changes in children's social communication and parental psychological distress and to compare maternal and paternal assessments at both time points. Parent satisfaction with the program was assessed following the intervention, and demographic and clinical factors associated with parent satisfaction were also examined.

详细描述

Autism is a neurodevelopmental condition characterized by persistent difficulties in social communication and the presence of restricted and repetitive behaviors. Parent-mediated interventions aim to equip caregivers with strategies that can be incorporated into everyday interactions with their children. Online group-based delivery may facilitate access to such interventions by reducing geographical and logistical barriers.

The OYNA program is an 8-week online group-based parent-mediated intervention for parents of young autistic children. The program incorporates psychoeducation, behavioral and developmental strategies, video-based coaching, therapist feedback, and structured home practice to support parents in applying intervention strategies during everyday interactions with their children.

This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of the OYNA program. Both mothers and fathers participated in the assessment process and independently completed measures concerning their child and their own psychological well-being. Children's social communication skills were assessed using the Social Communication Checklist-Revised (SCC-R), and parental psychological distress was assessed using the Depression Anxiety Stress Scales-21 (DASS-21) at baseline and immediately after the intervention.

The study was designed to examine changes in SCC-R and DASS-21 scores from baseline to post-intervention. Maternal and paternal SCC-R and DASS-21 scores were also compared at baseline and post-intervention to examine differences between parental reports. Agreement between maternal and paternal ratings of children's social communication was additionally evaluated.

Following completion of the intervention, mothers and fathers completed a Parent Satisfaction Questionnaire assessing satisfaction with the program, perceived benefits for their child, confidence in applying the strategies learned during the intervention, and their overall evaluation of the program. Maternal and paternal satisfaction scores were compared.

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
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Confirmed diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria
  • •Child aged 2-6 years
  • •Parent willingness to participate in all intervention sessions
  • •Participation of the same parent throughout the intervention program
  • •Agreement not to initiate another intervention program during the study period

排除标准

  • •Presence of medical conditions that could affect development, including genetic disorders, neurological disorders, or hearing impairment
  • •Participation in another structured intervention program during the study period

研究组 & 干预措施

OYNA Intervention Group

Experimental

Participants received the 8-week online group-based parent-mediated intervention (OYNA). The program consisted of weekly online group sessions including psychoeducation, behavioral and developmental strategies, video-based coaching and feedback, and structured home practice. Parents were supported in applying the strategies during everyday interactions and activities with their children.

干预措施: Online Group-Based Parent-Mediated Intervention (OYNA) (Behavioral)

结局指标

主要结局

Change in Child Social Communication Assessed by the Social Communication Checklist-Revised (SCC-R)

时间窗: Baseline and immediately after completion of the 8-week intervention

The Social Communication Checklist-Revised (SCC-R) is a 70-item parent-report measure used to assess social communication abilities in young children. It includes four domains: Social Engagement, Expressive Communication, Receptive Communication, and Imitation/Play Skills. Items are rated on a three-point scale, with higher scores indicating better social communication abilities. Mothers and fathers independently completed the SCC-R for the same child at baseline and immediately after the intervention. Changes in the SCC-R total score and domain scores from baseline to post-intervention were evaluated, with an increase in scores indicating improvement in social communication skills.

次要结局

  • Change in Parental Psychological Distress Assessed by the Depression Anxiety Stress Scales-21 (DASS-21)(Baseline and immediately after completion of the 8-week intervention)
  • Parent Satisfaction With the OYNA Intervention Assessed by the Parent Satisfaction Questionnaire(Immediately after completion of the 8-week intervention)
  • Comparison of Maternal and Paternal Social Communication Checklist-Revised (SCC-R) Scores(Baseline and immediately after completion of the 8-week intervention)
  • Comparison of Maternal and Paternal Depression Anxiety Stress Scales-21 (DASS-21) Scores(Baseline and immediately after completion of the 8-week intervention)
  • Comparison of Maternal and Paternal Parent Satisfaction Questionnaire Scores(Immediately after completion of the 8-week intervention)
  • Factors Associated With Parent Satisfaction With the OYNA Intervention(Immediately after completion of the 8-week intervention)

研究者

发起方
Herguner Therapy Private Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabri Hergüner

Associate Professor of Child and Adolescent Psychiatry

Herguner Therapy Private Clinic

研究点 (1)

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