Recruiting

Observational Study

Sponsor:

Canisius College

Code:

NCT05542602

Conditions

Autistic Disorder

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Not accepted

Interventions

Social intervention

Study Details

Brief summary:

Social skills interventions are sometimes used to treat the social impairments of higher-functioning children with autism spectrum disorder (hfASD; without intellectual disability). Despite the recognized need for such treatments, few children with hfASD receive social interventions. Efforts to develop and implement school social interventions have been hindered by barriers during the school day (e.g., lack of resources, staffing, training, and time). As such, there is a need for feasible and effective social interventions that can be delivered by non-professional (paraprofessional) school staff in school settings including after-school programs. The purpose of this study is to test the feasibility and initial efficacy of an after-school social intervention delivered by paraprofessionals in school settings for children with hfASD. Children will be randomly assigned to the social intervention group or a no-treatment control (waitlist) group. The intervention will be delivered by paraprofessionals four days per week (90 minutes per session) over eight weeks during the children's after-school program conducted at their schools. Sessions include social skills groups, social recreational games to practice skills, and behavioral reinforcement to strengthen learning. Feasibility will be assessed via implementation fidelity (accuracy), parent and child satisfaction ratings, and attendance and attrition rates. Outcomes will test the intervention effect on a child test of social-cognition, parent ratings of social skills and ASD symptoms, and behavioral coding of social competence by naïve raters during unstructured game play. Child outcome measures will be completed for both the social intervention group and no-treatment control (waitlist) group immediately prior to (pretest) and following (posttest) the eight-week intervention, and children initially assigned to the social intervention will also complete the assessments three months later (follow-up). Children assigned to the no-treatment control (waitlist) group will receive the social intervention after the intervention group completes the social intervention.

Conditions

Autistic Disorder

Study ID

NCT05542602

Start date

Dec 10, 2022

Status verified date

Feb, 2023

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Prior clinical diagnosis of ASD
  • Wechsler Abbreviated Scale of Intelligence-2nd Edition IQ score >70
  • Diagnostic confirmation via the Autism Diagnostic Interview-Revised

Exclusion Criteria:

  • Evidence of psychosis per parent report and prior psychiatric evaluation

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Social intervention

The social intervention consists of four 90-minute sessions per week delivered over eight weeks by paraprofessional staff to children with hfASD as part of their existing after-school program.

no intervention: No-treatment control

Children in the no-treatment control condition will receive no after-school social programming during the active social intervention study phase.

Interventions

Social intervention

The social intervention consists of four 90-minute sessions per week delivered over eight weeks by paraprofessional staff as part of the children's existing after-school program. The sessions follow a schedule and include social skills groups, social recreational games, and a reinforcement system to teach, practice, and reinforce targeted social knowledge and social skills. The sessions are manualized and include a specific instructional sequence and treatment (lesson) plan for the paraprofessional staff to implement. The children also earn points for use of the targeted skills (frequency of use) and each can earn a home or site-based reinforcer for reaching her/his targeted number of points each session. Each group is facilitated by two paraprofessionals, and includes 12-15 children including two with hfASD (the remaining will be typically-developing peers).

Primary outcome measure

  • Social Knowledge Assessment (SKA) [ Time Frame: Pretest (immediately prior to) and posttest (immediately following) the 8-week active social intervention phase for children in both conditions, and three months later (follow-up) for those randomized to the social intervention. ]

Central Contacts and Locations

Locations

Canisius College

Recruiting

Buffalo, New York, United States, 14208

Contacts

Christopher J Lopata, PsyD

716-888-2861lopatac@canisius.edu

More Information

Sponsor

Canisius College

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

  • social intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canisius College on 2023-02-08.