Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863520
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-03-14
Brief Title:
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare two school based interventions to manage anxiety in autistic students The main questions it aims to answer are 1 Compare the effectiveness of Facing Your Fears-School Based Program FYF-SB with Zones of Regulation ZOR on anxiety reduction and emotion regulation and 2 examine the feasibility and satisfaction of FYF-SB and ZOR according to students caregivers and school providers Autistic students with anxiety between 8-14 years will be randomized to either FYF-SB and ZOR They will participate in one of the programs for 12 weeks and pre post and follow-up measures will occur
Detailed Description:
Background and Significance Anxiety is very common for autistic youth and can significantly limit functioning and full participation across settings In school anxiety may negatively impact students attendance school performance peer relationships and extracurricular participation Unfortunately autistic youth have experienced long-standing difficulty accessing mental health care in community settings and this difficulty is even more pronounced for youth from historically underserved racial and ethnic backgrounds Cognitive-behavioral therapies CBT are evidence-based practices that are effective for anxious children with and without autism but have not yet been consistently available in schools Schools may be the best location to equitably manage the mental health symptoms of autistic youth In fact youth from low-income households andor other underserved communities are most likely to access services only in school settings Thus there is a critical need for evidence-based mental health interventions in schools for autistic students The primary purpose of the current study is to compare two school-based curriculums Facing Your Fears - Schools Based FYF-SB and Zones of Regulation ZOR on meaningful outcomes The results of this study will not only fill a significant gap in the literature but will provide practical information about the strengths and weaknesses of each program so that school leaders and other stakeholders can make informed decisions about program selection for autistic students
Study Aims Aim 1 Compare the effectiveness of FYF-SB and ZOR for 200 school-aged autistic students with interfering anxiety
Compare the effectiveness of FYF-SB and ZOR on a symptoms of anxiety primary and emotion dysregulation co-primary as rated by caregivers students teachers and masked research staff and b functional outcomes of priority to stakeholders including school attendance disciplinary action and academic participation secondary Hypothesis Students who received FYF-SB will show greater reduction of anxiety compared to students who received ZOR
Aim 2 Compare the acceptability appropriateness and feasibility of FYF-SB and ZOR via a mixed methods approach with students caregivers and school providers to aid in decision-making regarding program selection Secondary Following intervention completion participants will complete measures on acceptability appropriateness and feasibility of either FYF-SB or ZOR In addition a purposive subset of participants will participate in exit interviews to understand outcomes of interest including potential harms linked with either FYF-SB or ZOR
Aim 3 Examine autism symptom severity and anxiety symptoms severity as moderators of treatment response This exploratory aim may help answer questions regarding which program could work best for which students
Study Description This study is a multi-site cluster randomized controlled type 1 hybrid comparative effectiveness-implementation trial designed to examine whether FYF-SB or ZOR is more effective in treating anxiety in autistic students School administrators in Colorado and North Carolina will select schools with large numbers of students from historically underserved communities Randomization will occur at the school level to either FYF-SB 50 schools or ZOR 50 schools Interdisciplinary school providers ISPs will be trained in one of the interventions and then nominate autistic students with anxiety for participation ISPs will deliver the intervention programs to small groups 2-5 students in their schools Assessments will be conducted pre post and 6 months following program completion Independent evaluators masked to condition will complete post-assessments Implementation outcomes acceptability and feasibility will also be examined via mixed-methods and reported by students caregivers and ISPs
Main components of the intervention and comparator s The two school-based curriculums in this study are Facing Your Fears- School Based FYF-SB and Zones of Regulation ZOR Both are rooted in CBT principles but manage anxiety in different ways FYF-SB is based on disorder-specific CBT strategies tailored for reduction of anxiety symptoms and incorporates psychoeducation and graded exposure facing fears a little at a time to target anxiety ZOR is an example of a transdiagnostic approach to intervention and targets emotion dysregulation by focusing on four different emotional states called zones Students are taught strategies for managing emotions and how to stay in a certain zone A transdiagnostic treatment approach posit that when emotion regulation improves so to will psychiatric symptoms related to those emotions eg anxiety
Study Population There are three groups of participants in the study autistic students caregivers and interdisciplinary school providers ISPs 1 200 autistic students with interfering anxiety 8-14 years from historically underserved communities attending elementary or middle schools in Colorado or North Carolina 2 200 caregivers of the eligible autistic students and 3 150 ISPs eg school psychologists special educators speechlanguage pathologists occupational and physical therapists who work with autistic students
Primary Outcomes The primary outcome s for this study are 1 Screening for Childhood Anxiety and Related Emotional Disorders - ChildParent versions SCARED Birmaher et al 1999 The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents to be completed separately by caregivers and students prepost intervention and at 6 months follow-up A total score as well as cutoffs for specific domains of anxiety eg social generalized are obtained 2 Co-Primary Outcome Pediatric Anxiety Rating Scale- Autism Spectrum Disorder PARS-ASD Maddox et al 2020 The PARS-ASD is a clinician-rated semi-structured interview assessing anxiety severity and impairment over the past week modified for youth with ASD ages 5 to 17 from the original Pediatric Anxiety Rating Scale PARS RUPP Walkup et al 2013 The PARS-ASD will be administered by an independent evaluator IE masked to condition It includes a Symptom Checklist and five Severity Items
Secondary Outcomes There are multiple secondary outcomes 1 stakeholder patient-centered identified meaningful outcomes eg tardies school attendance grades number of elopements classroom participation use of coping strategies increase in social initiations number of phone calls home visits to the principal and number of expulsionssuspensions 2 Emotion Dysregulation Inventory EDI Mazefsky et al 2018 The EDI is a parent report measure of emotion dysregulation in youth with ASD and will be completed prepost intervention and at follow-up The EDI can be used as a self-report measure and can also be completed by school providers 3 The School Anxiety Scale-Teacher Report SAS-TR Lyneham et al 2008 is a 16-item teacher-reported measure of anxiety designed to assess the behavior of children at school from 5 to 12 years of age Items are answered on a four-point scale The measure provides a total score for anxiety scores ranging from 0-48 4 Strengths and Difficulties Questionnaire SDQ Goodman et al 2000 is a 25-item teacher parent and student reported tool measuring prosocial behavior and psychopathology of youth 3-16 years old5 Emotion Regulation Index for Children and Adolescents ERICA MacDermott et al 2010 is a 16-item self-report measure of social competence and emotion regulation for children between the ages of 9-16
Implementation Outcomes 1 CBT Program Use This brief measure will be administered to ISPs to obtain information about their knowledge and perceptions related to school based interventions including ZOR and FYF-SB 2 Acceptability Questionnaire A six-item acceptability questionnaire will be completed by students and caregivers asking them to respond to questions such as How much did you enjoy participating in FYF-SBZOR or My child is less anxious after participating in FYF-SBZOR A 5-point Likert scale will be used to rate their responses 3 Implementation Survey Brief evaluation forms using a 6-point Likert scale will be completed by ISPs post delivery of FYF-SBZOR to assess quality of the training feasibility acceptability and appropriateness of each program including the likelihood that providers will continue to implement the interventions once the study has ended 4 Semi-structured Exit Interviews A purposive subset of participants students ISPs caregivers will be engaged in semi-structured exit interviews conducted by an independent member of the research team designed to understand the acceptability appropriateness feasibility and potential harms or negative aspects of either FYF-SB and ZOR 5 FYF-SBZOR Treatment Fidelity Checklists for internal use only These checklists will assess ISPs adherence to either core components of FYF-SB or ZOR including the four ZOR key elements of preparation provision of structure quality of facilitation and adult evaluation of student learning The measures assesses the presenceabsence of core treatment components as well as quality of intervention delivery
Timeframe Assessments occur pre and post-intervention for primary and secondary outcomes Selected measures will also be administered at 6 months follow-up with the 6 month follow up as primary endpoint
Analytic Plan
General consideration of statistical modeling Between-arm imbalance of baseline characteristics will be examined using t and chi-square tests and evaluated based on summary statistics Intervention effect of FYF-SB as compared to ZOR will be assessed using Linear mixed effect model LMM for continuous outcomes and non-linear mixed effect model NLMM for categorical outcome such as school attendance To account for design effect of clustering trials random school cluster effect will be in the models for outcome without repeated measures while appropriate covariance structure of LMMNLMM accounting for both the design effect and the correlation of repeated measures will be used for outcome with repeated measures Transformation of outcome ie Square root or log will be used if normality assumption is violated Any imbalanced potential confounding variables will be adjusted for modeling Primary analysis will be conducted on intent-to-treat basis ITT LMM and NLMM will the primary method for dealing with missing value without data imputation since missing pattern would most likely be of the missing at random MAR pattern The change score from baseline to the end of intervention is considered to the primary effectiveness endpoint No type I error adjustment for multiple tests in a single model or multiple outcomes will be applied P 005 is deemed statistically significant No interim analysis will be performed To examine the robustness of primary analyses sensitivity analyses will be conducted including the same analyses among completers and analyses after missing data were imputed using Markov chain Monte Carlo MCMC method
Study Aims Aim 1 Compare the effectiveness of FYF-SB and ZOR for 200 school-aged autistic students with interfering anxiety
Compare the effectiveness of FYF-SB and ZOR on a symptoms of anxiety primary and emotion dysregulation co-primary as rated by caregivers students teachers and masked research staff and b functional outcomes of priority to stakeholders including school attendance disciplinary action and academic participation secondary Hypothesis Students who received FYF-SB will show greater reduction of anxiety compared to students who received ZOR
Aim 2 Compare the acceptability appropriateness and feasibility of FYF-SB and ZOR via a mixed methods approach with students caregivers and school providers to aid in decision-making regarding program selection Secondary Following intervention completion participants will complete measures on acceptability appropriateness and feasibility of either FYF-SB or ZOR In addition a purposive subset of participants will participate in exit interviews to understand outcomes of interest including potential harms linked with either FYF-SB or ZOR
Aim 3 Examine autism symptom severity and anxiety symptoms severity as moderators of treatment response This exploratory aim may help answer questions regarding which program could work best for which students
Study Description This study is a multi-site cluster randomized controlled type 1 hybrid comparative effectiveness-implementation trial designed to examine whether FYF-SB or ZOR is more effective in treating anxiety in autistic students School administrators in Colorado and North Carolina will select schools with large numbers of students from historically underserved communities Randomization will occur at the school level to either FYF-SB 50 schools or ZOR 50 schools Interdisciplinary school providers ISPs will be trained in one of the interventions and then nominate autistic students with anxiety for participation ISPs will deliver the intervention programs to small groups 2-5 students in their schools Assessments will be conducted pre post and 6 months following program completion Independent evaluators masked to condition will complete post-assessments Implementation outcomes acceptability and feasibility will also be examined via mixed-methods and reported by students caregivers and ISPs
Main components of the intervention and comparator s The two school-based curriculums in this study are Facing Your Fears- School Based FYF-SB and Zones of Regulation ZOR Both are rooted in CBT principles but manage anxiety in different ways FYF-SB is based on disorder-specific CBT strategies tailored for reduction of anxiety symptoms and incorporates psychoeducation and graded exposure facing fears a little at a time to target anxiety ZOR is an example of a transdiagnostic approach to intervention and targets emotion dysregulation by focusing on four different emotional states called zones Students are taught strategies for managing emotions and how to stay in a certain zone A transdiagnostic treatment approach posit that when emotion regulation improves so to will psychiatric symptoms related to those emotions eg anxiety
Study Population There are three groups of participants in the study autistic students caregivers and interdisciplinary school providers ISPs 1 200 autistic students with interfering anxiety 8-14 years from historically underserved communities attending elementary or middle schools in Colorado or North Carolina 2 200 caregivers of the eligible autistic students and 3 150 ISPs eg school psychologists special educators speechlanguage pathologists occupational and physical therapists who work with autistic students
Primary Outcomes The primary outcome s for this study are 1 Screening for Childhood Anxiety and Related Emotional Disorders - ChildParent versions SCARED Birmaher et al 1999 The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents to be completed separately by caregivers and students prepost intervention and at 6 months follow-up A total score as well as cutoffs for specific domains of anxiety eg social generalized are obtained 2 Co-Primary Outcome Pediatric Anxiety Rating Scale- Autism Spectrum Disorder PARS-ASD Maddox et al 2020 The PARS-ASD is a clinician-rated semi-structured interview assessing anxiety severity and impairment over the past week modified for youth with ASD ages 5 to 17 from the original Pediatric Anxiety Rating Scale PARS RUPP Walkup et al 2013 The PARS-ASD will be administered by an independent evaluator IE masked to condition It includes a Symptom Checklist and five Severity Items
Secondary Outcomes There are multiple secondary outcomes 1 stakeholder patient-centered identified meaningful outcomes eg tardies school attendance grades number of elopements classroom participation use of coping strategies increase in social initiations number of phone calls home visits to the principal and number of expulsionssuspensions 2 Emotion Dysregulation Inventory EDI Mazefsky et al 2018 The EDI is a parent report measure of emotion dysregulation in youth with ASD and will be completed prepost intervention and at follow-up The EDI can be used as a self-report measure and can also be completed by school providers 3 The School Anxiety Scale-Teacher Report SAS-TR Lyneham et al 2008 is a 16-item teacher-reported measure of anxiety designed to assess the behavior of children at school from 5 to 12 years of age Items are answered on a four-point scale The measure provides a total score for anxiety scores ranging from 0-48 4 Strengths and Difficulties Questionnaire SDQ Goodman et al 2000 is a 25-item teacher parent and student reported tool measuring prosocial behavior and psychopathology of youth 3-16 years old5 Emotion Regulation Index for Children and Adolescents ERICA MacDermott et al 2010 is a 16-item self-report measure of social competence and emotion regulation for children between the ages of 9-16
Implementation Outcomes 1 CBT Program Use This brief measure will be administered to ISPs to obtain information about their knowledge and perceptions related to school based interventions including ZOR and FYF-SB 2 Acceptability Questionnaire A six-item acceptability questionnaire will be completed by students and caregivers asking them to respond to questions such as How much did you enjoy participating in FYF-SBZOR or My child is less anxious after participating in FYF-SBZOR A 5-point Likert scale will be used to rate their responses 3 Implementation Survey Brief evaluation forms using a 6-point Likert scale will be completed by ISPs post delivery of FYF-SBZOR to assess quality of the training feasibility acceptability and appropriateness of each program including the likelihood that providers will continue to implement the interventions once the study has ended 4 Semi-structured Exit Interviews A purposive subset of participants students ISPs caregivers will be engaged in semi-structured exit interviews conducted by an independent member of the research team designed to understand the acceptability appropriateness feasibility and potential harms or negative aspects of either FYF-SB and ZOR 5 FYF-SBZOR Treatment Fidelity Checklists for internal use only These checklists will assess ISPs adherence to either core components of FYF-SB or ZOR including the four ZOR key elements of preparation provision of structure quality of facilitation and adult evaluation of student learning The measures assesses the presenceabsence of core treatment components as well as quality of intervention delivery
Timeframe Assessments occur pre and post-intervention for primary and secondary outcomes Selected measures will also be administered at 6 months follow-up with the 6 month follow up as primary endpoint
Analytic Plan
General consideration of statistical modeling Between-arm imbalance of baseline characteristics will be examined using t and chi-square tests and evaluated based on summary statistics Intervention effect of FYF-SB as compared to ZOR will be assessed using Linear mixed effect model LMM for continuous outcomes and non-linear mixed effect model NLMM for categorical outcome such as school attendance To account for design effect of clustering trials random school cluster effect will be in the models for outcome without repeated measures while appropriate covariance structure of LMMNLMM accounting for both the design effect and the correlation of repeated measures will be used for outcome with repeated measures Transformation of outcome ie Square root or log will be used if normality assumption is violated Any imbalanced potential confounding variables will be adjusted for modeling Primary analysis will be conducted on intent-to-treat basis ITT LMM and NLMM will the primary method for dealing with missing value without data imputation since missing pattern would most likely be of the missing at random MAR pattern The change score from baseline to the end of intervention is considered to the primary effectiveness endpoint No type I error adjustment for multiple tests in a single model or multiple outcomes will be applied P 005 is deemed statistically significant No interim analysis will be performed To examine the robustness of primary analyses sensitivity analyses will be conducted including the same analyses among completers and analyses after missing data were imputed using Markov chain Monte Carlo MCMC method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None