Developing Mental Health Supports for Autistic Students

NCT04926090 | Completed

• 1 other identifier: Pro2021000076
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Depression, Anxiety

Keywords

smartphone; ecological momentary intervention (EMI); ecological momentary assessment (EMA)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Adult Self Report

  15 week monitoring period

• Change in Adult Behavior Checklist

  15 week monitoring period

• Change in Emotion Dysregulation Inventory

  15 week monitoring period

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

  15 week monitoring period

Study Arms (3)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

Interventions

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

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.

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

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Vanessa H Bal, PhD

  Rutgers University - New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: July 26, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)