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Study of a Paraprofessional-Delivered After-School Social Intervention for Autistic Children

Not Applicable
Recruiting
Conditions
Autistic Disorder
Interventions
Behavioral: Social intervention
Registration Number
NCT05542602
Lead Sponsor
Canisius College
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.

Detailed Description

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 higher-functioning children with autism spectrum disorder (hfASD; without intellectual disability). 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 social-cognition, social skills, ASD symptoms, and social competence. For feasibility, it is hypothesized that: (1) paraprofessionals will demonstrate fidelity \>90% throughout the social intervention; (2) satisfaction ratings will be high (parents will report an average satisfaction item M\>6.0 and children will report an average satisfaction item M\>5.0 of a maximum 7=completely satisfied); (3) the attendance rate will be \>90% (on average) across the program; and (4) the attrition rate will be \<5%. For child outcomes, it is hypothesized that children in the social intervention group will demonstrate significantly greater improvements compared to the no-treatment control (waitlist) group in social-cognitive knowledge, parent ratings of social skills, parent ratings of ASD symptom severity, and ratings of social performance (measured via direct behavioral observations by masked raters). It is also hypothesized that children initially randomized to the social intervention group will maintain the intervention effects three months after the social intervention.

A pilot randomized controlled trial (RCT; pretest-posttest control group design) will be conducted. Children will be recruited using announcements disseminated by district administrators and parents and children will be required to provide written parental consent and written child assent initially for participation in the screening (to determine eligibility) and subsequently for participation in the social intervention study (for those meeting eligibility criteria). Paraprofessionals will complete a 20-hour training and demonstrate \>90% fidelity implementing the intervention. Children will be randomly assigned by the study statistician to the social intervention group or no-treatment control (waitlist) group. The manualized social intervention is then delivered to those randomized to the social intervention group on-site at the students' schools as part of the schools' existing after-school programming provided by paraprofessionals. The social intervention is delivered four days per week (90 minutes per session) over eight weeks in group format. Sessions are structured and include social skills groups, social recreational games, and a reinforcement system. Each group will be facilitated by two paraprofessionals, and include 12-15 children including two with hfASD (the remaining will be typically-developing peers). A comprehensive set of fidelity monitoring procedures are used to track implementation accuracy in the social intervention group, as well as document any therapeutic services received by the control group children. Satisfaction ratings (parent and child) are collected after completion of the social intervention. Child outcome measures are 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
48
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Social interventionSocial interventionThe 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.
Primary Outcome Measures
NameTimeMethod
Social Knowledge Assessment (SKA)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.

Test of social-cognition/knowledge (mean change from pretest score). The Social Knowledge Assessment yields a total score that can range from 0 to 167, and a higher total score indicates better social-cognition/knowledge (better outcome).

Secondary Outcome Measures
NameTimeMethod
Adapted Skillstreaming Checklist (ASC)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.

Ratings of social skills (mean change from pretest score). The Adapted Skillstreaming Checklist yields a total score that can range from 38 to 190, and a higher total score indicates better social/social-communication skills (better outcome).

Social Responsiveness Scale, 2nd Edition, School Age Form (SRS-2)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.

Ratings of ASD-symptom severity (mean change from pretest score). The Social Responsiveness Scale, 2nd Edition, School Age Form yields a total T score (mean score of 50 and standard deviation of 10), and a higher total T score indicates greater ASD symptom severity (worse outcome).

Social Competence Observation Scale (SCOS)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.

Observations of the children's social performance by masked coders (mean change from pretest score). The Social Competence Observation Scale yields a single Social Impairment Severity (SIS) score ranging from 1 = normal to 7 = extreme deficit, and a higher score indicates more severe impairment (worse outcome).

Trial Locations

Locations (1)

Canisius College

🇺🇸

Buffalo, New York, United States

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