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Developing Mental Health Supports for Autistic Students

Primary Purpose

Autism Spectrum Disorder, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Support Plan - Clinician Guided (ESP-C)
Emotional Support Plan - Self Guided (ESP-S)
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Autism Spectrum Disorder focused on measuring smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Emotional Support Plan - Clinician Guided (ESP-C) + (Bi)Weekly Monitoring

Emotional Support Plan - Clinician Guided (ESP-C) + 4x Daily Monitoring

Emotional Support Plan - Self Guided (ESP-S) + 4x Daily Monitoring

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 8, 2021
Last Updated
August 9, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Organization for Autism Research
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1. Study Identification

Unique Protocol Identification Number
NCT04926090
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Organization for Autism Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Depression, Anxiety
Keywords
smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional Support Plan - Clinician Guided (ESP-C) + (Bi)Weekly Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Emotional Support Plan - Clinician Guided (ESP-C) + 4x Daily Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Emotional Support Plan - Self Guided (ESP-S) + 4x Daily Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Support Plan - Clinician Guided (ESP-C)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Support Plan - Self Guided (ESP-S)
Intervention Description
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 Outcome Measure Information:
Title
Change in distress on Patient Health Questionnaire (PHQ-9)
Description
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
Title
Change in distress on Ecological Momentary Assessment (EMA) reports
Description
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
Title
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
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
Secondary Outcome Measure Information:
Title
Change in Adult Self Report
Description
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
Title
Change in Adult Behavior Checklist
Description
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
Title
Change in Emotion Dysregulation Inventory
Description
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
Title
Change Young Adult Coping Orientation for Problem Experience (YA-COPE)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa H Bal, PhD
Organizational Affiliation
Rutgers University - New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Developing Mental Health Supports for Autistic Students

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