Parent Training Program for Preschool Children With Autism Spectrum Disorders

NCT03725644 | Completed DMC

• 1 other identifier: B-BR-103-065
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change Scores of Functional Emotional Assessment Scale

  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.

  14 weeks

Secondary Outcomes (2)

• Change Scores of Chinese Version of Psychoeducational Profile - Third Edition

  14 weeks

• Change Scores of Vineland Adaptive Behavior Scales

  14 weeks

Other Outcomes (1)

• Intensity daily logs

  14 weeks

Study Arms (2)

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.

Behavioral: parent-training program

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.

Behavioral: traditional program

Interventions

parent-training program BEHAVIORAL

Parents in the treatment group received the training program from the registered pediatric occupational therapist in six hours over three weeks. The occupational therapist provided suggestions and gave feedback. The parents were encouraged to interact with their children for at least 15 hours per week. Between the fourth and 14th weeks, the parents implemented the intervention programs at home and recorded the daily intensity. The occupational therapist met with the parents and children at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered and to practice the child-initiated activities.

parent-training program

traditional program BEHAVIORAL

Parents in the control group also conducted a 14-week program. They received six hours of training over three weeks.Between the fourth and 14th weeks, the parents implemented parent-led activities at home and recorded the daily intensity. The parents were encouraged to do activities with their children for at least 15 hours per week. The occupational therapist met with the parents at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered while practicing the parent-led activities.

traditional program

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng Kung University: lead

Related Publications (1)

• 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.

  PMID: 24865120 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ling Yi Lin

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 31, 2018
• Study Start: January 29, 2015
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting in January 2023
• Access Criteria: Supporting information will be shared to pediatric occupational therapists, researchers, and parents with autism.