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Developing Mental Health Supports for Autistic Students

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04926090
Enrollment
19
Registered
2021-06-14
Start date
2021-07-26
Completion date
2022-07-27
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Depression, Anxiety

Keywords

smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)

Brief summary

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

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.

Interventions

BEHAVIORALEmotional Support Plan - Clinician Guided (ESP-C)

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.

BEHAVIORALEmotional 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-S is created by the participant on their own, with the support of self-guided materials.

Sponsors

Organization for Autism Research
CollaboratorOTHER
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in distress on Patient Health Questionnaire (PHQ-9)15 week monitoring periodThe 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.
Change in distress on Ecological Momentary Assessment (EMA) reports15 week monitoring periodEMA (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.
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)15 week monitoring periodThe 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.

Secondary

MeasureTime frameDescription
Change in Adult Self Report15 week monitoring periodThe 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.
Change Young Adult Coping Orientation for Problem Experience (YA-COPE)15 week monitoring periodThe 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.
Change in Adult Behavior Checklist15 week monitoring periodThe 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.
Change in Emotion Dysregulation Inventory15 week monitoring periodThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026