Clinical trial NCT03725644: Parent Training Program for Preschool Children With Autism Spectrum Disorders
Official title: Effectiveness of Floortime Intervention Program for Preschool Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. mild to severe symptoms of ASD according to the Standard Version of Childhood Autism Rating Scale - Second edition (CARS2-ST; Schopler et al., 2010);
3. children aged 36 to 71 months old;
4. 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;
5. children whose caregivers' educational level were at or above middle school so that they could read manuals and complete the questionnaires.

Exclusion Criteria:

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

Primary outcomes:
measure: Change Scores of Functional Emotional Assessment Scale
timeFrame: 14 weeks
Secondary outcomes:
measure: Change Scores of Chinese Version of Psychoeducational Profile - Third Edition
timeFrame: 14 weeks
measure: Change Scores of Vineland Adaptive Behavior Scales
timeFrame: 14 weeks
Other outcomes:
measure: Intensity daily logs
timeFrame: 14 weeks
Locations:
Study officials:
affiliation: National Cheng Kung University
name: Ling Yi Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao ST, Hwang YS, Chen YJ, Lee P, Chen SJ, Lin LY. Home-based DIR/Floortime intervention program for preschool children with autism spectrum disorders: preliminary findings. Phys Occup Ther Pediatr. 2014 Nov;34(4):356-67. doi: 10.3109/01942638.2014.918074. Epub 2014 May 27.