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Clinical Trials/NCT03725644
NCT03725644
Completed
N/A

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

National Cheng Kung University0 sites40 target enrollmentJanuary 29, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
National Cheng Kung University
Enrollment
40
Primary Endpoint
Change Scores of Functional Emotional Assessment Scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 29, 2015
End Date
September 30, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ling-Yi Lin

Associate Professor

National Cheng Kung University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change Scores of Functional Emotional Assessment Scale

Time Frame: 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.

Secondary Outcomes

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

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