Investigation of Effectiveness of an Intensive Caregiver-involved Group- Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers- A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mullen Early Scale Learning
Study Overview
Brief Summary
This is a study that investigate the feasibility, acceptability, and preliminary efficacy of NDBIs for autistic preschoolers delivered in a group-setting. The outcome measures assess the improvements in autistic symptoms, social communication, play skills, group behaviors, adaptation, and parent stress.
Detailed Description
Autism spectrum disorder (ASD) is characterized by persistent social communication deficits and restricted behaviors. Global prevalence is 1-2%, with 1% in Taiwan. Social interaction obstacles and repetitive behaviors impact ASD individuals in various contexts, emphasizing the need for effective interventions. Current treatments focus on behavioral approaches, particularly Naturalistic Developmental Behavioral Interventions (NDBIs). NDBIs improve social engagement, cognitive development, and language skills. Parent-mediated intervention (PMI) enhances treatment effectiveness and reduces parenting stress. However, many NDBIs are conducted in one-on-one settings, limiting feasibility, especially in schools. Group-based interventions are beneficial and more feasible in the communities, but limited research exists. In Taiwan, early interventions, covered by National Health Insurance, lack intensity and parent involvement. The study aims to establish an intensive, parent-involved, group-based NDBIs program. The pilot randomized controlled trial will assess its feasibility, acceptability, and preliminary efficacy in improving autistic symptoms, social and play skills, group behaviors, general adaptation, and reducing parenting stress.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinically diagnosed as Autism Spectrum Disorder
- •aged 2-6 years old
- •one of caregivers is able to participate treatment sessions.
Exclusion Criteria
- •having other major diseases.
Arms & Interventions
experimental group
ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y)
Intervention: Group-based Naturalistic Developmental Behavioral Intervention (Behavioral)
experimental group
ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y)
Intervention: ASD Diagnosis (Behavioral)
active control group
ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y)
Intervention: One-on-one Naturalistic Developmental Behavioral Intervention (Behavioral)
active control group
ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y)
Intervention: ASD Diagnosis (Behavioral)
Outcomes
Primary Outcomes
Mullen Early Scale Learning
Time Frame: 50 minutes
A comprehensive measure of cognitive functioning for infants and preschool children from birth to 68 months, consisting of five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. The maximum raw score is 50 and will be transformed into T score based on the child's age, which can then be used to determine the percentile rank and scale age equivalent.
Individual Growth and Development Indicators
Time Frame: 15 minutes
A play-based observational measure assessing communication, motor function, sociability, and problem solving in toddlers. In this study, we will use the subscale sociability (Early social indicator). The ESI lasts for 6-minutes while key communication skills and social skills will be counted as number, the rate of key skills (per-minute) will be generated and used for analysis.
Treatment fidelity
Time Frame: 10 minutes
The treatment fidelity is used to assess the feasibility of the program. A 10-minutes clip of the treatment session will be coded according to NDBI-Fi or adapted NDBI-Fi.
Attendance rate
Time Frame: 5 minutes
The attendance rate is used to evaluate the acceptability of the program for participating families
The completion of the assessment
Time Frame: 5 minutes
The completion of the assessment would be investigated by checking whether all the outcome measures are completed by the assessors or caregivers.
Vineland Adaptive Behavior Scales - Third Edition, Chinese Version (VABS-3)
Time Frame: 20 minutes
It is a widely used and well validated measurement for assessing adaptive behaviors in individuals, rated by caregivers and teachers. It consists of 4 domains: communication, daily living skills, socialization, and motor skills. These domains encompass 11 subdomains, including receptive, expressive, written, personal, domestic, community, interpersonal relationships, play and leisure, coping skills, gross motor, and fine motor. The raw scores will be transformed to standard score ranged from 20 to 140 with a higher number representing better adaptation.
Secondary Outcomes
- Autism Treatment Evaluation Checklist(10 minutes)
- Family Empowerment Scale(5 minutes)
- Autism Parenting Stress Index(5 minutes)
- Child Behavior Checklist(20 minutes)