NCT04551313

Brief Summary

Socio-communicative impairments are core deficits in individuals with autism spectrum disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial expressions, body language, and different tones of voice when communicating with others. They can't interpret the thoughts and feelings of others, or predict social events, and the impaired social skills may lead to rejection of peers and poor participation in school. Social skills training targets the core symptoms of ASD. Empirical support is building for cognitive-behavioral intervention approach, social skills training group for verbally fluent, school-aged children with ASD. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

September 3, 2020

Last Update Submit

August 16, 2023

Conditions

Keywords

Autism,autism spectrum disorder,social skill training

Outcome Measures

Primary Outcomes (2)

  • GAS (Goal attainment scale)

    interview caregivers about specific social interaction goals for the children and give rating 1-5 to calculate the extent to which a parent's goals are met.

    the first week and the 15th week of the duration

  • Vineland Adaptive Behavior Scale

    to assess the socialization skill of the children.

    the first week and the 15th week of the duration

Study Arms (2)

social skill training group

EXPERIMENTAL

We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.

Behavioral: social skill group

control group

ACTIVE COMPARATOR

Regular therapy

Behavioral: social skill group

Interventions

We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.

control groupsocial skill training group

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of Autism spectrum disorder
  • Must be able to understand 3-steps verbal commands

You may not qualify if:

  • Mental retardation
  • Seizure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

NTUH

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Fu-Mei Chiang, MAMS

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 16, 2020

Study Start

October 19, 2020

Primary Completion

July 27, 2022

Study Completion

July 27, 2022

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations