Study of a Paraprofessional-Delivered After-School Social Intervention for Autistic Children
Feasibility and Initial Efficacy of an After-School Social Intervention Delivered by Paraprofessionals in School Settings for Children With ASD
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
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 11, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedStudy Start
First participant enrolled
December 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedFebruary 8, 2023
February 1, 2023
2.5 years
September 11, 2022
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Social Knowledge Assessment (SKA)
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).
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 (3)
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.
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.
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.
Other Outcomes (5)
Parent Satisfaction Survey
Completed immediately after completion of the social intervention
Child Satisfaction Survey
Completed immediately after completion of the social intervention
Fidelity Measure
Measured throughout intervention implementation (up to 8 weeks)
- +2 more other outcomes
Study Arms (2)
Social intervention
EXPERIMENTALThe 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-treatment control
NO INTERVENTIONChildren in the no-treatment control condition will receive no after-school social programming during the active social intervention study phase.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Prior clinical diagnosis of ASD
- Wechsler Abbreviated Scale of Intelligence-2nd Edition IQ score \>70
- Diagnostic confirmation via the Autism Diagnostic Interview-Revised
You may not qualify if:
- Evidence of psychosis per parent report and prior psychiatric evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canisius Collegelead
Study Sites (1)
Canisius College
Buffalo, New York, 14208, United States
Related Publications (4)
Constantino JN., Gruber CP (2012). Social Responsiveness Scale, Second Edition (SRS-2). Torrance, CA: Western Psychological Services.
BACKGROUNDLopata 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.
PMID: 18058012BACKGROUNDLopata 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.
PMID: 20232240BACKGROUNDLopata 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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Two of the child outcome measures are completed by masked outcome evaluators including a test of social-cognition/knowledge and behavioral observations of the children's social performance during unstructured free-play periods with peers. These outcome evaluators work in a separate lab space and do not have access to information on the study condition of the children.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 11, 2022
First Posted
September 15, 2022
Study Start
December 10, 2022
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available upon study completion and publication and/or submission to the NDA, and will be available for a period of at least 10 years
- Access Criteria
- There are no pre-established criteria for data access or use
The final datafile will be available for sharing. This will include demographic data and raw, derived, and standard scores. Item-level data will be available including raw item-level data with variable and value labels, all computed variables created during scoring, and all scale scores for standard scores. A data codebook and dictionary that lists each measure, variable name/label, scoring instructions, and supporting references will also be available. Each subject will be assigned a unique identification number so that no personally identifiable information is present. The principal investigator will receive requests for data-sharing, and ensure the datafile and supporting documents are transferred to the requesting individual. Other study-related materials and products will also be made available upon request (e.g., study protocol, informed consent form, etc.). The final research data will also be submitted to the NIMH Data Archive and will be accessible to other researchers.