NCT02147236

Brief Summary

To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum Disorders.Following a diagnostic and social skills assessment,children are randomly assigned to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability of gains during the first 16 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1.5 years

First QC Date

May 21, 2014

Last Update Submit

May 21, 2014

Conditions

Pervasive Developmental Disorders

Keywords

autismpervasive developmental disorderssocial skills intervention

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression for Improvement

    16 weeks

Secondary Outcomes (1)

  • Social Competence Inventory

    16 weeks

Interventions

Social Skills TrainingBEHAVIORAL

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 11 years
  • Full Scale IQ score \> 70
  • PDD diagnosis (autism, Asperger's, PDD-Not Otherwise Specified)

You may not qualify if:

  • concurrent, untreated psychiatric disorder(such as anxiety, depression or conduct disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Child Development Disorders, PervasiveAutistic Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAutism Spectrum Disorder

Study Officials

  • Lawrence D Scahill, MSN,PhD

    Yale University Child Study Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 26, 2014

Study Start

July 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)