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临床试验/NCT03725644
NCT03725644已完成不适用

Effectiveness of Floortime Intervention Program for Preschool Children With Autism Spectrum Disorders

National Cheng Kung University0 个研究点目标入组 40 人开始时间: 2015年1月29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
40
主要终点
Change Scores of Functional Emotional Assessment Scale

研究概览

简要总结

Previous research has showed that parent-training programs derived from the developmental individual-difference relationship-based model (DIR) could improve the communicative development of children with autism spectrum disorder (ASD). However, the empirical evidence is weak. This study therefore examines whether a DIR-based parent-training program can improve children's adaptive functioning and parents' parenting skills using a rigorous randomized controlled trial design with a dose-matched control group. Forty preschool children with autism spectrum disorder (ASD) and their parents were randomly assigned to the parent-training program group or the traditional program group at the pre-test phase. Both groups received 14-week intervention programs and were assessed using pre- and post-tests. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.

详细描述

Introduction

Preschool children with autism spectrum disorder and their parents face many difficulties in daily lives, including children's adaptive functioning, parenting skills, and parenting stress. Therefore, effective and economical interventions are very important to support them. With appropriate theoretical bases, a parent-training program could be effective, economical, and feasible while the clinical manpower is insufficient. Among current intervention programs, the play concept and the developmental, individual difference, and relationship-based (DIR) model match the philosophy of occupational therapy. Previous research had showed the play- and DIR-based parent-training programs would improve children's communicative development. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's adaptive functioning. Moreover, the results of improvement in parenting skills and reduction of parenting stress were not consistent. Aim: This study would implement a dose-matched control group and comprehensive measurements to examine if the play- and DIR-based parent-training program would improve children's adaptive functioning and parents' parenting skills as well as reduce parenting stress. Hypotheses: We hypothesized that the better improvements would show in the parent-training program than those in the traditional program. Method: We recruited 40 preschool children with autism spectrum disorder and their parents and randomly assigned them to either the parent-training program group or the traditional program group after pretest phase. Both of them conducted 14-week intervention programs and were assessed after interventions. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.

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
36 Months 至 71 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children with a diagnosis of ASD according to the Diagnostic and Statistics Manual of Mental Disorders - Fifth edition (DSM-5; APA, 2013) by registered pediatric psychiatrists;
  • mild to severe symptoms of ASD according to the Standard Version of Childhood Autism Rating Scale - Second edition (CARS2-ST; Schopler et al., 2010);
  • children aged 36 to 71 months old;
  • children whose primary caregivers (parents who cared for their child for over 15 hours per week - except during sleep time) used Mandarin as their main language;
  • children whose caregivers' educational level were at or above middle school so that they could read manuals and complete the questionnaires.

排除标准

  • children who attended other intensive interventions (e.g., 25 hours per week) or had been diagnosed with additional diseases or disorders;
  • parents who attended other parent-training programs at the same time.

研究组 & 干预措施

parent-training program

Experimental

Parents in the treatment group received the parent-training program based on the DIR model. The parent-training program encouraged child-initiated activities according to the functional developmental levels. The treatment intensity and duration were the same for both groups including 3-week courses and 11-week home programs. The investigators in this study are two registered pediatric occupational therapists who have at least five years of early intervention experience and had studied the DIR model.

干预措施: parent-training program (Behavioral)

traditional program

Experimental

Parents in the control group received the traditional program based on the developmental approach. The traditional program provided parent-lead activities that fit child's developmental stage.

干预措施: traditional program (Behavioral)

结局指标

主要结局

Change Scores of Functional Emotional Assessment Scale

时间窗: 14 weeks

The Functional Emotional Assessment Scale (FEAS; Greenspan et al., 2001) is based on six functional developmental levels of the developmental individual-difference relationship-based model and divided into two parts that (1) examine the children's development and (2) assess the parenting skills. All parents in the study were asked to record their parent-child activities as 15-minute videos. All videos were coded using random numbers to hide the research information (e.g. groups and test time). Two videos (pre- and post-test) were reviewed for each child. Using the Chinese version of the Scoring Form translated by Liao et al. (2014; intraclass correlation coefficient = 0.85), each item of the FEAS was rated as 0, 1 or 2. Higher raw scores represent better functions and skills. The total score is summed and ranges from 0 to 80.

次要结局

  • Change Scores of Vineland Adaptive Behavior Scales(14 weeks)
  • Change Scores of Chinese Version of Psychoeducational Profile - Third Edition(14 weeks)

研究者

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

Ling-Yi Lin

Associate Professor

National Cheng Kung University

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