Clinical trial NCT05542602: Study of a Paraprofessional-Delivered After-School Social Intervention for Autistic Children
Official title: Feasibility and Initial Efficacy of an After-School Social Intervention Delivered by Paraprofessionals in School Settings for Children With ASD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autistic Disorder
Keywords: social intervention
Lead sponsor: Canisius College
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study utilizes a parallel group design consisting of two study conditions (study arms). Condition one consists of the social intervention (intervention being tested) and condition two consists of a no-treatment control comparison group (i.e., waitlist control group).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social Knowledge Assessment (SKA)
timeFrame: 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.
Secondary outcomes:
measure: Adapted Skillstreaming Checklist (ASC)
timeFrame: 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.
measure: Social Responsiveness Scale, 2nd Edition, School Age Form (SRS-2)
timeFrame: 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.
measure: Social Competence Observation Scale (SCOS)
timeFrame: 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.
Other outcomes:
measure: Parent Satisfaction Survey
timeFrame: Completed immediately after completion of the social intervention
measure: Child Satisfaction Survey
timeFrame: Completed immediately after completion of the social intervention
measure: Fidelity Measure
timeFrame: Measured throughout intervention implementation (up to 8 weeks)
measure: Attendance Rate
timeFrame: Measured throughout intervention implementation (up to 8 weeks)
measure: Attrition Rate
timeFrame: Measured throughout intervention implementation (up to 8 weeks)
Locations:
city: Buffalo
country: United States
facility: Canisius College
state: New York
Study officials:
References:
citation: Constantino JN., Gruber CP (2012). Social Responsiveness Scale, Second Edition (SRS-2). Torrance, CA: Western Psychological Services.
citation: Lopata C, Thomeer ML, Volker MA, Nida RE, Lee GK. Effectiveness of a manualized summer social treatment program for high-functioning children with autism spectrum disorders. J Autism Dev Disord. 2008 May;38(5):890-904. doi: 10.1007/s10803-007-0460-7.
citation: Lopata C, Thomeer ML, Volker MA, Toomey JA, Nida RE, Lee GK, Smerbeck AM, Rodgers JD. RCT of a manualized social treatment for high-functioning autism spectrum disorders. J Autism Dev Disord. 2010 Nov;40(11):1297-310. doi: 10.1007/s10803-010-0989-8.
citation: Lopata C, Rodgers JD, Donnelly JP, Thomeer ML, Kozlowski KF, Lodi-Smith J. Development and pilot testing of the Social Competence Observation Scale (SCOS) for children with ASD. Journal of Developmental and Physical Disabilities. 2022; doi: 10.1007/s10882-021-09830-9