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

Autism Spectrum Disorder Clinical Trial

Official title:

Investigation of Effectiveness of an Intensive Caregiver-involved Group- Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers- A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221943
• Other study ID #: 202310088RIND
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Guan-Jye Seng, M.S.
• Phone: +886-5-5323911
• Email: sophiasft[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 randomized controlled trial will assess its effectiveness in improving autistic symptoms, social and play skills, group behaviors, general adaptation, and reducing parenting stress.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• clinically diagnosed as Autism Spectrum Disorder

• aged 2-6 years old

• one of caregivers is able to participate all treatment sessions.

Exclusion Criteria:

• having other comorbid neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Group-based Naturalistic Developmental Behavioral Intervention
Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in a group setting.
• One-on-one Naturalistic Developmental Behavioral Intervention
Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in an one-on-one setting
• ASD Diagnosis
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Responsiveness Scale	The SRS is a parent-rated scale to identify autistic characteristics dimensionally, consisting of four dimensions: social communication, social awareness, social emotion, and stereotyped behaviors. The SRS contains 65 likert-scaled (1-4) items, generating a singular scale with a score ranged from 0-195. A higher score indicates greater impairment.	10 minutes
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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