Clinical trial NCT06221943: Effectiveness of Caregiver-involved Group-based NDBIs Intervention for Autistic Preschoolers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Naturalistic Developmental Behavioral Intervention
Effectiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Autism Treatment Evaluation Checklist
timeFrame: 10 minutes
measure: Mullen Early Scale Learning
timeFrame: 50 minutes
measure: Individual Growth and Development Indicators
timeFrame: 15 minutes
measure: Structured Play Assessment
timeFrame: 30 minutes
measure: Preschool and Kindergarten Behavior Scale-Second Edition
timeFrame: 15 minutes
measure: Vineland Adaptive Behavior Scales - Third Edition, Chinese Version (VABS-3)
timeFrame: 20 minutes
measure: Autism Parenting Stress Index
timeFrame: 5 minutes
measure: Family Empowerment Scale
timeFrame: 5 minutes
Secondary outcomes:
measure: Assessment of Preschool Children's Participation
timeFrame: 20 minutes
measure: Repetitive Behavior Scale-Revised
timeFrame: 10 minutes
measure: Child Behavior Checklist
timeFrame: 20 minutes
measure: Autism Stigma and Knowledge Questionnaire
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
Study officials:
References: