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Completed

NCT Number: NCT04926090

Developing Mental Health Supports for Autistic Students

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.

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Key information

Conditions

Autism Spectrum Disorder Anxiety Disorders Behavior Behavioral Symptoms Child Development Disorders, Pervasive Depression Depression, Anxiety Mental Disorders Neurodevelopmental Disorders

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotional Support Plan - Clinician Guided (ESP-C)

Behavioral

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.

Emotional Support Plan - Self Guided (ESP-S)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Adult Self Report

    Time frame: 15 week monitoring period

    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.

  2. Change in Adult Behavior Checklist

    Time frame: 15 week monitoring period

    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.

  3. Change in Emotion Dysregulation Inventory

    Time frame: 15 week monitoring period

    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.

  4. Change Young Adult Coping Orientation for Problem Experience (YA-COPE)

    Time frame: 15 week monitoring period

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Organization for Autism Research

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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