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Completed

NCT Number: NCT03725644

Parent Training Program for Preschool Children With Autism Spectrum Disorders

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Change Scores of Chinese Version of Psychoeducational Profile - Third Edition

    Time frame: 14 weeks

    The performance scale of the Chinese Version of Psychoeducational Profile-3 (Schopler et al., 2005; Heep Hong Society, 2013) comprises six subtests for developmental abilities (cognitive verbal/preverbal, expressive language, receptive language, fine motor, gross motor and visual-motor imitation), which are summed to create communication and motor composites. The score of each item is rated as 0, 1 or 2. All six subtests for developmental abilities can be converted to age-equivalent and composite scores. The communication and motor composites scores range from 0 to 60. The higher the scores are, the better function the children achieve.

  2. Change Scores of Vineland Adaptive Behavior Scales

    Time frame: 14 weeks

    The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.

Other outcomes

  1. Intensity daily logs

    Time frame: 14 weeks

    All parents recorded intensity (intervention hours per day) using the online Google form or paper daily logs so that their compliance with program implementation could be monitored. The parents also recorded the intensity of the regular interventions that the children received.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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