Developing Mental Health Supports for Autistic Students

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT04926090
Collaborator
Organization for Autism Research (Other)
19
1
3
12
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotional Support Plan - Clinician Guided (ESP-C)
  • Behavioral: Emotional Support Plan - Self Guided (ESP-S)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Developing Supports to Address Mental Health Needs of Autistic Students in Postsecondary Education
Actual Study Start Date :
Jul 26, 2021
Actual Primary Completion Date :
Jul 27, 2022
Actual Study Completion Date :
Jul 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Emotional Support Plan - Clinician Guided (ESP-C) + (Bi)Weekly Monitoring

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.

Behavioral: Emotional 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.

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

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.

Behavioral: Emotional 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.

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

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.

Behavioral: Emotional 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.

Outcome Measures

Primary Outcome Measures

  1. Change in distress on Patient Health Questionnaire (PHQ-9) [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 [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) [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 Outcome Measures

  1. Change in Adult Self Report [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 [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers University Piscataway New Jersey United States 08854

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey
  • Organization for Autism Research

Investigators

  • Principal Investigator: Vanessa H Bal, PhD, Rutgers University - New Brunswick

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vanessa H. Bal, PhD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT04926090
Other Study ID Numbers:
  • Pro2021000076
First Posted:
Jun 14, 2021
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vanessa H. Bal, PhD, Associate Professor, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022