Effectiveness of Caregiver-involved Group-based NDBIs Intervention for Autistic Preschoolers

NCT06221943 | Completed DMC

• 1 other identifier: 202310088RIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Naturalistic Developmental Behavioral Intervention; Effectiveness

Outcome Measures

Primary Outcomes (6)

• Mullen Early Scale Learning

  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.

  50 minutes

• Individual Growth and Development Indicators

  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.

  15 minutes

• Vineland Adaptive Behavior Scales - Third Edition, Chinese Version (VABS-3)

  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.

  20 minutes

• Treatment fidelity

  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.

  10 minutes

• Attendance rate

  The attendance rate is used to evaluate the acceptability of the program for participating families

  5 minutes

• The completion of the assessment

  The completion of the assessment would be investigated by checking whether all the outcome measures are completed by the assessors or caregivers.

  5 minutes

Secondary Outcomes (4)

• Child Behavior Checklist

  20 minutes

• Autism Treatment Evaluation Checklist

  10 minutes

• Family Empowerment Scale

  5 minutes

• Autism Parenting Stress Index

  5 minutes

Other Outcomes (5)

• Structured Play Assessment

  30 minutes

• Repetitive Behavior Scale-Revised

  10 minutes

• Assessment of Preschool Children's Participation

  20 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y)

Behavioral: Group-based Naturalistic Developmental Behavioral Intervention; Behavioral: ASD Diagnosis

active control group

ACTIVE COMPARATOR

ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y)

Behavioral: One-on-one Naturalistic Developmental Behavioral Intervention; Behavioral: ASD Diagnosis

Interventions

One-on-one Naturalistic Developmental Behavioral Intervention BEHAVIORAL

Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in an one-on-one setting

active control group

ASD Diagnosis BEHAVIORAL

Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)

active control group; experimental group

Group-based Naturalistic Developmental Behavioral Intervention BEHAVIORAL

Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in a group setting.

experimental group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinically diagnosed as Autism Spectrum Disorder
• aged 2-6 years old
• one of caregivers is able to participate treatment sessions.

You may not qualify if:

• having other major diseases.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

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: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: January 1, 2024
• Primary Completion: March 20, 2025
• Study Completion: May 31, 2025
• Last Updated: July 10, 2026

Record last verified: 2025-09

Locations

TW (1)