Developing Mental Health Supports for Autistic Students

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Depression, Anxiety
• Intervention / Treatment: Behavioral: Emotional Support Plan - Clinician Guided (ESP-C); Behavioral: Emotional Support Plan - Self Guided (ESP-S)

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Rutgers University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 week monitoring period
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.	15 week monitoring period
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.	15 week monitoring period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 week monitoring period
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.	15 week monitoring period
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.	15 week monitoring period
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.	15 week monitoring period

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Organization for Autism Research
• Investigators: Principal Investigator: Vanessa H Bal, PhD, Rutgers University - New Brunswick

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: smartphone; ecological momentary assessment (EMA); ecological momentary intervention (EMI)
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: Pro2021000076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No