Developing Mental Health Supports for Autistic Students

Study Overview
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Brief Summary
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The present study aims to expand the availability of emotional supports in order to promote successful transitions and longer-term outcomes for autistic students in PSE.

Detailed Description
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This study has three specific aims: Aim 1: Identify mental health needs of autistic students to inform supports. Focus groups engaging key stakeholders will be used to understand the mental health needs of autistic college students and inform adaptation of two individualized mental health supports: 1) the ESP intervention and 2) protocols for monitoring mood and psychological distress. Aim 2: Develop resources to inform and guide mental health care of autistic students. Focus group information will inform 1) adaptation of clinician (ESP-C) and self-guided (ESP-S) emotional support plans and monitoring protocols and 2) develop a College Student Mental Health Guide to aide autistic college students, their families and mental health professionals in proactive planning for mental health supports during PSE. Aim 3: Assess the feasibility, acceptability and initial efficacy of the ESP-C and ESP-S. The study will yield preliminary data to apply for additional funding to conduct a large-scale trial to validate these methods to monitor and support mental health of autistic adults. Information gathered from the study will also be used to inform development of a mental health guide for autistic students.

Official Title
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Developing Supports to Address Mental Health Needs of Autistic Students in Postsecondary Education

Conditions
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Autism Spectrum Disorder, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Emotional Support Plan - Clinician Guided (ESP-C)
* Behavioral: Emotional Support Plan - Self Guided (ESP-S)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous ASD diagnosis, Has smartphone (to access the ESP app) At least 6th grade Reading Comprehension on the WRAT-5. The WRAT-5 may not be required if a student has other evidence of age-appropriate reading level. Be currently enrolled in a Postsecondary Education (PSE) institution. Exclusion Criteria: Not a students in a PSE Institution or do not have diagnosis of ASD Score below a 6th grade Reading Comprehension on the WRAT-5 Unable to understand English No access to a compatible iOS and Android smartphone the PI's clinical judgment that it would not be in the adult's best interest to be enrolled

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotional Support Plan - Clinician Guided (ESP-C) + (Bi)Weekly Monitoring<br>This will involve brief assessment visits throughout the fall semester, without prompting to use the ESP-C. Visits will be weekly for the first 6 weeks and then biweekly for the remaining 9 weeks of the term. | Behavioral: Emotional Support Plan - Clinician Guided (ESP-C)<br>* The Emotional Support Plan (ESP) is designed to help prepare students to cope with stress experienced during postsecondary education. The ESP-C is delivered by a clinician in 2 sessions.<br>|
| Experimental: Emotional Support Plan - Clinician Guided (ESP-C) + 4x Daily Monitoring<br>Participants in this arm will be prompted on their phones 4x/day, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt. They will also participate in brief assessment visits conducted weekly for the first 6 weeks and then biweekly for the remaining 9 weeks of the term. | Behavioral: Emotional Support Plan - Clinician Guided (ESP-C)<br>* The Emotional Support Plan (ESP) is designed to help prepare students to cope with stress experienced during postsecondary education. The ESP-C is delivered by a clinician in 2 sessions.<br>|
| Experimental: Emotional Support Plan - Self Guided (ESP-S) + 4x Daily Monitoring<br>Participants in this arm will be prompted on their phones 4x/day, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt. They will be asked to complete questionnaires weekly for the first 6 weeks and then biweekly for the remaining 9 weeks of the term. | Behavioral: Emotional Support Plan - Self Guided (ESP-S)<br>* The Emotional Support Plan (ESP) is designed to help prepare students to cope with stress experienced during postsecondary education. The ESP-S is created by the participant on their own, with the support of self-guided materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distress on Patient Health Questionnaire (PHQ-9) | The PHQ-9, assessed weekly for first 6 weeks and biweekly for remaining 9 weeks, is a 9-item questionnaire of psychological function over the past week with all items on a 0 (not at all) to 3 (nearly every day) scale. Higher scores equal more distress. | 15 week monitoring period | 
| Change in distress on Ecological Momentary Assessment (EMA) reports | EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring groups only). Scores range from 0(not at all) to 5 (very much). Higher scores on the item equal higher levels of distress. | 15 week monitoring period | 
| Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7) | The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a 0 (not at all) to 3 (nearly every day) scale. Higher scores equal more anxiety. | 15 week monitoring period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adult Self Report | The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true. Higher scores equal more symptoms. | 15 week monitoring period | 
| Change in Adult Behavior Checklist | The ABCL is a caregiver-report measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true. Higher scores equal more symptoms. | 15 week monitoring period | 
| Change in Emotion Dysregulation Inventory | The EDI is a measure of emotion dysregulation designed for use with individuals with autism. Items are rated on a scale of 0-5. Higher score equal more symptoms. | 15 week monitoring period | 
| Change Young Adult Coping Orientation for Problem Experience (YA-COPE) | The YA-COPE is a 56-item measure designed to capture coping behaviors of college students. Items are rated on a scale of 1(never) to 5 (most of the time. Higher scores indicate more positive strategies. | 15 week monitoring period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)