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

NCT06221943 | Recruiting DMC

• 1 other identifier: 202310088RIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study that investigate the effectiveness of NDBIs for autistic preschoolers delivered in group-settings and one-on-one settings. 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 (8)

• Autism Treatment Evaluation Checklist

  The Autism Treatment Evaluation Checklist (ATEC) is a tool with 77 items (likert-scaled 0-3) designed to evaluate treatment effectiveness for individuals with autism. It comprises four subscales: Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical Behavior. The reduced scores represented the improvement in these areas.The total score of the ATEC ranges from 0 to 180, with a higher score indicating greater severity of autism symptoms.

  10 minutes

• 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 of communication (Early communication indicator) and sociability (Early social indicator). Each measure 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

• Structured Play Assessment

  A semi-structured assessment used to measure children's spontaneous play acts. The two indicators are the play diversity and the play complexity. The play acts are hierarchically ordered into 16 play levels. Play diversity represents the number of types of play acts are displayed, while play complexity refers to the highest level of the child's play acts.

  30 minutes

• Preschool and Kindergarten Behavior Scale-Second Edition

  It is a parent-report or teacher-report questionnaire targeting young children's behaviors in preschools, consisting of social skills scale and problem behavior scale. The social skills scale consists of 34 likert-scaled item (0-3), with a higher score indicating better social skills. The problem behavior scale consists of 42 likert-scaled item (0-3), with a higher score indicating more severe problem behaviors.

  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

• Autism Parenting Stress Index

  This questionnaire is used to gauge parental stress from the perspective of parents or caregivers of young children with autism. The test items are grouped into three categories: fundamental social difficulties (item 1,2,11,12,13), challenging behavior management (item 3,4,5,6), and physical concerns (item 7,8,9,10). The total score ranges from 0 to 52, with 0 indicating not stressful, 1 indicating sometimes creates stress, 2 indicating often creates stress, 3 indicating very stressful on a daily basis, and 5 indicating so stressful sometimes we feel we can't cope.

  5 minutes

• Family Empowerment Scale

  It is a 5-point caregiver-reported questionnaire consisting of 34 items, which is used to measure the family empowerment in caregiving for children with special needs. The score ranges from 34-170, with a higher score representing a high level of empowerment.

  5 minutes

Secondary Outcomes (4)

• Assessment of Preschool Children's Participation

  20 minutes

• Repetitive Behavior Scale-Revised

  10 minutes

• Child Behavior Checklist

  20 minutes

• Autism Stigma and Knowledge Questionnaire

  10 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

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

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

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

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Guan-Jye Seng, M.S.

CONTACT

+886-5-5323911; sophiasft@gmail.com

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: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

TW (1)