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Clinical Trials/NCT04926090
NCT04926090
Completed
N/A

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

Rutgers, The State University of New Jersey1 site in 1 country19 target enrollmentJuly 26, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Rutgers, The State University of New Jersey
Enrollment
19
Locations
1
Primary Endpoint
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 26, 2021
End Date
July 27, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vanessa H. Bal, PhD

Associate Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • Previous ASD diagnosis,
  • Has smartphone (to access the ESP app)
  • At least 6th grade Reading Comprehension on the WRAT-
  • 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

Outcomes

Primary Outcomes

Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

Time Frame: 15 week monitoring period

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.

Change in distress on Patient Health Questionnaire (PHQ-9)

Time Frame: 15 week monitoring period

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.

Change in distress on Ecological Momentary Assessment (EMA) reports

Time Frame: 15 week monitoring period

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.

Secondary Outcomes

  • Change Young Adult Coping Orientation for Problem Experience (YA-COPE)(15 week monitoring period)
  • Change in Adult Self Report(15 week monitoring period)
  • Change in Adult Behavior Checklist(15 week monitoring period)
  • Change in Emotion Dysregulation Inventory(15 week monitoring period)

Study Sites (1)

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