Developing Mental Health Supports for Autistic Students

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926090
• Other study ID #: Pro2021000076
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: July 27, 2022

Study information

• Verified date: August 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Depression, Anxiety

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rutgers University	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Organization for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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