- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03338530
Efficacy of a Comprehensive School-based Intervention for High-functioning Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The efficacy of the comprehensive school-based intervention (CSBI) was evaluated in a cluster randomized trial (pretest-posttest control group design). A total of 96 students in grades 1-5 with HFASD from 32 public elementary schools were initially targeted for enrollment over the 4-year study period. Once students were screened and determined to meet eligibility criteria, individual schools (clusters) were randomly assigned to either the treatment condition (CSBI) or control condition (business-as-usual [BAU]). A block randomization design with stratification by school economic level was used to insure approximate balance among the treatment groups. Recruitment was conducted during the 4-8 months prior to the upcoming school year. School staff from the treatment schools completed a manualized 5-day training during the summer preceding the treatment year and demonstrated fidelity with the protocol (competence). Pretesting was completed 6 weeks into the school year (prior to the initiation of the intervention) and posttesting at the end of the school year following completion of the intervention. Children with HFASD in the CSBI schools received the CSBI intervention implemented by school staff during the school year and children with HFASD in the BAU schools received their typical special education programming. Implementation accuracy (fidelity) was assessed by research assistants throughout the school year in the CSBI schools using standardized fidelity monitoring sheets. The fidelity monitoring sheets were also completed by research assistants during observations in the BAU schools in order to identify the possible presence of any of the treatment elements in the BAU schools.
Treatment (CSBI) group protocol. The following is a description of the 5 treatment components (SSGs, IDN, MR, TAs, and PT) and fidelity protocol for the CSBI.
Social skills groups (SSGs). SSGs were conducted 2-3x/wk. for a total of 60-90 min./wk. by a designated member of the school team. Groups contained 3-6 students with social impairments. Each manualized SSG began with a review of rules and was then conducted according to the framework of Skillstreaming (Goldstein et al., 1997). Skillstreaming is a structured program for teaching interpersonal skills to children with social deficits using teaching, modeling, role-playing, performance feedback, and transfer of learning (McGinnis & Goldstein, 1997). In the CSBI, 26 social skills were taught in a progression from basic to more complex. While the SSG protocol required active participation of every child each session, each child was required to be the primary role-player at least twice per 3 sessions. Each session ended with a short review and discussion of how to use the skill in future classroom activities. To ensure repeated practice and ongoing feedback, and promote generalization, 1) each participant had >2 social targets on her/his IDN (see IDN section), 2) classroom teachers displayed a list of the social skills taught to date and the component steps of each social skill, and 3) parents were continually informed of target skills. Fidelity of implementation. SSG facilitators recorded the date, attendees, minutes of group instruction, and skill for each session on a tracking sheet and research assistants monitored fidelity at least 1x/wk. using a standardized fidelity sheet.
Individual daily note (IDN). The IDN was administered across the school day and was used to practice and reinforce newly learned skills, and reduce problem behaviors/ASD symptoms. It directed the student, school team, and parents to focus on specific skills/behaviors and performance criteria, and promoted communication between school and home. Each IDN consisted of 3-5 operationally-defined targets; to increase generalization >2 were skills taught in the CSBI. Initially, IDN targets were identified by teachers and operationally defined, and base rate data were collected for 3-5 days to determine criteria for IDN goals. Each student's school day was then divided into intervals based on his/her reinforcement needs. At the end of each interval, the student could earn 1 point for each IDN target and must have earned >75% of her/his daily points to receive a home reward (reinforcer). During each interval, the student received immediate verbal feedback and a tally was recorded on his/her IDN. At the end of each interval, the teacher provided feedback on the student's performance during that interval based on the targets and performance criteria. At the end of the day, the teacher informed the student of her/his overall performance (% earned), sent a copy of the IDN home, and retained a copy of the IDN. Fidelity of implementation. A copy of each child's IDN was kept by the classroom teacher and collected every 2 weeks. Adherence was assessed during at least two 60-min. observations each week using a standardized fidelity sheet.
Mind Reading (MR) computer instruction. MR was conducted 3x/wk. for a total of 60 min./wk. by a designated member of the school team. MR is an interactive software program designed to teach recognition of emotions in facial and vocal formats (Baron-Cohen et al., 2004). It features 412 emotions organized into 24 emotion groups and by 6 emotion levels. The program presents instruction and tasks in the Emotions Library, Learning Center, and Games Zone and reinforcing activities in the Rewards Zone. It also employs a token system to reinforce participants with access to the Rewards Zone using points earned for accurate completion of questions in MR. The CSBI included 100 MR emotions divided into 10 groups (10 emotions per group). Each week students were taught 1 group of emotions (repeated during the 3 lessons). After each emotion group was taught, students repeated the 10 emotion groups 2 more times for a total of 3 exposures to the 10 groups. Each session was manualized to ensure children met time parameters accessing areas of MR. School staff members monitored students to ensure they accessed program areas according to the protocol. Fidelity of implementation. Data on time using the software for each participant were collected by an internal chronometer in the software and research assistants monitored implementation accuracy at least once per week using a standardized fidelity sheet.
Therapeutic activities (TAs). TAs were conducted 2x/wk. for a total of 40-60 min./wk. by a designated member of the classroom team. TAs required >2 students and were conducted to practice and reinforce social skills and face-emotion recognition, and promote interest expansion. Each TA was written as a lesson plan that described the activity, its purpose, skill targeted, materials needed, deficit addressed, and procedures for conducting the activity. TAs were conducted with general and/or special education peers. At the outset, facilitators reviewed the activity rules and quickly discussed the activity. The facilitator also discussed with the target student how she/he can use the target and previously taught skills during the activity. During TAs, facilitators maintained proximity to the target students and provided frequent reinforcement when students exhibited target skills and corrective feedback when necessary. Each TA ended with a quick debriefing (1-3 min.) including how students used target skills during the TA and how they can use these skills during the school day/week. Fidelity of implementation. TA facilitators recorded the date, attendees, minutes of instruction, and skill targeted for each session on a tracking sheet. Research assistants monitored fidelity at least 3x/month using a standardized fidelity sheet.
Parent training (PT). PT was conducted 1x/month for 60-90 min./session during the school year by at least 1 member of the school team. This served to increase home-school communication and integrate the CSBI across settings. It also fostered active parent participation in the establishment of home reinforcers for school performance on treatment targets and increased parental understanding of the CSBI. PT content and instructional procedures were manualized to ensure delivery of consistent content. Facilitators delivered content using detailed lesson plans and PowerPoint slides or showed a video recording of the session(s) (which covered the same lesson plans and PowerPoints). Each session was structured as follows: 1) Brief updates on CSBI and PT agenda; 2) Lesson content (delivered live or via video); 3) Discussion of content and integration of content into daily routine; and 4) Review of session content and implementation procedures. Fidelity of implementation. PT facilitators recorded the date, attendees, duration of session, and topic covered for each session on a tracking sheet. Research assistants monitored fidelity at least 1x per 2 PT sessions using a standardized fidelity sheet.
Consultation support. Consultants provided support for classroom teams via weekly meetings. Consultants generally consisted of graduate students with advanced training in assessment and treatment of ASD/HFASD. Most were recruited from prior psychosocial treatment trials for children with HFASD conducted by our team and, as such they had extensive training and experience in administering the active components of the CSBI, and the fidelity, data collection, and data entry procedures. Fidelity of implementation. Consultants met with teams at least 1x/wk. and documented meetings on a log which included the school/team, date, time, topic(s), and outcome. The logs were reviewed monthly and child progress was reviewed at weekly consultant case review meetings with the study's clinical director.
Comparison (BAU) group protocol. Research indicates that students with HFASD do not receive adequate, intensive, or comprehensive school interventions (White, Scahill et al., 2007). This suggested that students randomly assigned to the control (BAU) condition would not receive services that remotely approximated the intensity or scope of the CSBI. Given randomization at the school level, contamination was unlikely however we monitored the roles of school staff and excluded any staff member (e.g., related-service provider) who provided services across buildings. The services received by the control children (programming and services mandated on their IEPs) were also monitored to ensure they were sufficiently different from the CSBI group. Four procedures were used. 1) Each student's IEP was reviewed to identify and document the legally mandated services she/he received. 2) For those receiving counseling (group or individual) or speech-language services, the related-service provider completed a survey indicating specific treatment targets and the protocol for service provision (techniques used, number of trials, etc.). 3) Parents completed a monthly survey of any external therapeutic or social-communicative programming their child may have received. 4) Fidelity measures designed for the intervention group (with sequencing requirements removed) were completed for the control condition during two 60-minute classroom observations per week by research assistants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: (1) WISC-IV short form IQ>70 (and VCI or PRI>80); (2) CASL expressive or receptive language score >75; and (3) a score meeting ASD criteria on the ADI-R
Exclusion Criteria: Evidence of psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Comprehensive School-Based Intervention
Children with HFASD assigned to the CSBI received social skills groups, computer instruction in emotion recognition, therapeutic activities, and a behavioral reinforcement system (individual daily note) during the school year and their parents participated in monthly parent training.
School staff received training prior to the school year and demonstrated fidelity with the protocol.
Fidelity was also monitored during the school year by research assistants.
|
School staff administered the 5 components during the school year.
Social Skills Groups were conducted 2-3x/wk.
for a total of 60-90 min./wk.; each group contained 3-6 students with social impairments.
The Individual Daily Note was administered across the school day to reinforce new skills and reduce problem symptoms.
Students' performance on targets was linked to home rewards.
Mind Reading computer instruction targeting emotion recognition skills was conducted 3x/wk.
for a total of 60 min./wk.
Therapeutic Activities were conducted 2x/wk.
for a total of 40-60 min./wk.; these cooperative activities were designed to practice targeted skills.
Parent Training was conducted 1x/month for 60-90 min./session in order to increase home-school communication and integrate the CSBI across settings.
|
|
No Intervention: Business-As-Usual (BAU) Control
Children with HFASD in the BAU schools received their typical special education programming as legally-mandated.
The programming received by each was carefully monitored per the following: 1) Each student's IEP was reviewed to document the legally mandated services received; 2) For those receiving counseling or speech-language services, the related-service provider completed a survey indicating specific treatment targets and the protocol for service provision; 3) Parents completed a monthly survey of any external therapeutic programming their child may have received; and 4) Fidelity measures designed for the intervention group (with sequencing requirements removed) were completed for the control condition during two 60-minute classroom observations per week by research assistants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Cambridge Mindreading Face-Voice Battery for Children (CAM-C) Scores at Follow-up
Time Frame: Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
Total score used to assess emotion recognition skills; scores range from 0 to 90, with higher scores indicating better emotion recognition accuracy/skills
|
Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
|
Change from Baseline Social Responsiveness Scale, 2nd Edition, School Age Form (SRS-2) Scores at Follow-up
Time Frame: Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
SRS-2 total composite score normative mean = 50 and standard deviation = 10, with higher scores indicating more severe autism spectrum disorder symptoms/impairments
|
Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Adapted Skillstreaming Checklist (ASC) Scores at Follow-up
Time Frame: Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
Total ASC score used to assess social/social-communication skills; scores range from 38 to 190, with higher scores indicating greater use of social/social-communication skills
|
Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
|
Change from Baseline Woodcock-Johnson III Tests of Achievement (WJ III ACH) Scores at Follow-up
Time Frame: Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
Standard scores (mean = 100 and standard deviation = 15) used from the Letter Word Identification, Calculation, Spelling, Passage Comprehension, and Writing Samples subtests, with higher scores indicating better academic skills
|
Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
|
Change from Baseline Social Interaction Observation Scale (SIOS) Scores at Follow-up
Time Frame: Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
Total SIOS score used to measure the frequency of social interactions during social activities, with higher total scores indicating more social interactions
|
Baseline (immediately prior to treatment) and follow-up (immediately following treatment)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher J Lopata, PsyD, Institute for Autism Reseach, Canisius College
Publications and helpful links
General Publications
- Goldstein, A. P., McGinnis, E., Sprafkin, R. P., Gershaw, N. J., & Klein, P. (1997). Skillstreaming the adolescent: New strategies and perspectives for teaching prosocial skills, revised edition. Champaign, IL: Research Press.
- McGinnis, E., & Goldstein, A. P. (1997). Skillstreaming the elementary school child: New strategies and perspectives for teaching prosocial skills, revised edition. Champaign, Il: Research Press.
- Baron-Cohen, S., Golan, O., Wheelwright, S., & Hill, J. J. (2004). Mind reading: The intervention guide to emotions. London: Jessica Kingsley Limited (www.jkp.com).
- White SW, Scahill L, Klin A, Koenig K, Volkmar FR. Educational placements and service use patterns of individuals with autism spectrum disorders. J Autism Dev Disord. 2007 Sep;37(8):1403-12. doi: 10.1007/s10803-006-0281-0. Epub 2006 Nov 3.
- Golan O, Baron-Cohen S. Systemizing empathy: teaching adults with Asperger syndrome or high-functioning autism to recognize complex emotions using interactive multimedia. Dev Psychopathol. 2006 Spring;18(2):591-617. doi: 10.1017/S0954579406060305.
- Constantino, J. N., & Gruber, C. P. (2012). Social responsiveness scale, Second Edition (SRS-2). Torrance, CA: Western Psychological Services.
- 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.
- 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.
- Woodcock, R. W., McGrew, K. S., & Mather, N. (2001). Woodcock-Johnson III Tests of Achievement. Itasca, IL: Riverside Publishing.
- Bauminger N. The facilitation of social-emotional understanding and social interaction in high-functioning children with autism: intervention outcomes. J Autism Dev Disord. 2002 Aug;32(4):283-98. doi: 10.1023/a:1016378718278.
- Wechsler, D. (2003). Wechsler Intelligence Scale for Children (4th ed.). San Antonio, TX: The Psychological Corporation.
- Carrow-Woolfolk, E. (1999). Comprehensive Assessment of Spoken Language. Circle Pines, MN: American Guidance Services.
- Rutter, M., LeCouteur, A., & Lord, C. (2003). Autism Diagnostic Interview-Revised. Los Angeles: Western Psychological Services.
- Lopata C, Thomeer ML, Rodgers JD, Donnelly JP, McDonald CA, Volker MA, Smith TH, Wang H. Cluster Randomized Trial of a School Intervention for Children with Autism Spectrum Disorder. J Clin Child Adolesc Psychol. 2019 Nov-Dec;48(6):922-933. doi: 10.1080/15374416.2018.1520121. Epub 2018 Oct 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-13#142RENEWAL-Ammend
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Adia Med of Winter Park LLCActive, not recruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Poznan University of Physical EducationNational Science Centre, PolandCompletedAutism Spectrum Disorder | ASD | Autism Spectrum Disorder High-Functioning | Autism SpectrumPoland
-
Blinklab LimitedRecruitingAutism Spectrum Disorder | Autism | Neurodevelopmental Conditions | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
National Cheng-Kung University HospitalCompletedAutism Spectrum Disorder (ASD) | Autism Spectrum Disorder High-FunctioningTaiwan
-
Healing Hope InternationalKurve Technology Inc.Enrolling by invitationNeurodevelopmental Disorders | Autism Spectrum Disorder | Autistic Disorder | Autism Spectrum Disorder (ASD) | Autistic Disorders Spectrum | Autism Spectrum Disorder High-Functioning | Autism Spectrum Disorder With Impaired Functional Language | Autistic Disorder of Childhood Onset With Full Syndrome and other conditionsUnited States
-
Stanford UniversityCalifornia Department of Developmental ServicesActive, not recruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
Clinical Trials on Comprehensive School-Based Intervention
-
Nordic Institute for Studies of Innovation, Research...University of Agder; The Institute of Transport Economics, Norway; Fredrikstad... and other collaboratorsRecruitingPhysical Inactivity | Health LiteracyNorway
-
Universiti Putra MalaysiaUniversity of LahoreNot yet recruitingObesity, Childhood | Child Behavior | Child ObesityPakistan
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
Hong Kong Baptist UniversityCompletedObesity | Intellectual Disability | Health-related Physical FitnessChina
-
University of AlbertaCompletedChildhood ObesityCanada
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH) and other collaboratorsCompleted
-
University of GiessenUniversity of DhakaUnknownTobacco Prevention | Tobacco | Schools
-
University of HoustonBaylor College of MedicineCompleted
-
The Children's Hospital of Zhejiang University...Not yet recruitingHPV | Vaccination Hesitancy | Biopsychosocial Model
-
Children's Hospital Medical Center, CincinnatiActive, not recruitingSuicidality | Depression DisordersUnited States