Clinical trial NCT04926090: Developing Mental Health Supports for Autistic Students
Official title: Developing Supports to Address Mental Health Needs of Autistic Students in Postsecondary Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Depression, Anxiety
Keywords: smartphone
ecological momentary intervention (EMI)
ecological momentary assessment (EMA)
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Organization for Autism Research
First posted: 2021-06-14
Enrollment: 19
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in distress on Patient Health Questionnaire (PHQ-9)
timeFrame: 15 week monitoring period
measure: Change in distress on Ecological Momentary Assessment (EMA) reports
timeFrame: 15 week monitoring period
measure: Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: 15 week monitoring period
Secondary outcomes:
measure: Change in Adult Self Report
timeFrame: 15 week monitoring period
measure: Change in Adult Behavior Checklist
timeFrame: 15 week monitoring period
measure: Change in Emotion Dysregulation Inventory
timeFrame: 15 week monitoring period
measure: Change Young Adult Coping Orientation for Problem Experience (YA-COPE)
timeFrame: 15 week monitoring period
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers University - New Brunswick
name: Vanessa H Bal, PhD
role: PRINCIPAL_INVESTIGATOR
References: