Group-based intervention for autistic preschoolers involving caregivers
Investigation of Effectiveness of an Intensive Caregiver-involved Group- Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers- A Pilot Randomized Controlled Trial
This study is testing a group program that helps preschoolers with autism improve their social skills and play while also supporting their parents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Douliu) |
| Trial ID | NCT06221943 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Naturalistic Developmental Behavioral Interventions (NDBIs) for preschoolers diagnosed with Autism Spectrum Disorder (ASD) in both group and one-on-one settings. It aims to improve various aspects of autistic symptoms, including social communication, play skills, and group behaviors, while also addressing parent stress. The study will utilize a randomized controlled trial design to evaluate the outcomes of an intensive, parent-involved, group-based NDBIs program, which is particularly relevant in the context of Taiwan where early interventions are often limited. The findings could provide valuable insights into the feasibility and effectiveness of group-based interventions in community settings.
Who should consider this trial
Good fit: Ideal candidates for this study are preschoolers aged 2-6 years who have a clinical diagnosis of Autism Spectrum Disorder and have a caregiver willing to participate in treatment sessions.
Not a fit: Patients with other major diseases may not receive benefit from this study due to potential confounding factors affecting their treatment outcomes.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance social engagement and developmental skills in autistic preschoolers while reducing stress for their parents.
How similar studies have performed: While group-based NDBIs have shown promise in other contexts, this specific approach in Taiwan is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Douliu
- National Taiwan University Hospital Yunlin Branch — Douliu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Guan-Jye Seng, M.S.
- Email: sophiasft@gmail.com
- Phone: +886-5-5323911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.