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

National Taiwan University

Status: Enrolling

Conditions: Autism Spectrum Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06221943

202310088RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

experimental group

Experimental group

Description:

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

Treatment:

Behavioral: Group-based Naturalistic Developmental Behavioral Intervention

Behavioral: ASD Diagnosis

active control group

Active Comparator group

Description:

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

Treatment:

Behavioral: One-on-one Naturalistic Developmental Behavioral Intervention

Behavioral: ASD Diagnosis