An interventional study of Emotional Support Plan - Clinician Guided (ESP-C) and Emotional Support Plan - Self Guided (ESP-S) in Autism Spectrum Disorder and Depression, Anxiety, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention
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.
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.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's enrollment of 19 is below the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Rutgers, The State University of New Jersey is the lead sponsor of 504 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Exclusion Criteria:
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)
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)
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)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 15 week monitoring period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 15 week monitoring period
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Jul 2022, 12 months.
Of 801 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 12 months is below that.
Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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