Developing Mental Health Supports for Autistic Students

NCT ID: NCT04926090

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2022-07-27

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.

Conditions

Autism Spectrum Disorder; Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Emotional Support Plan - Clinician Guided (ESP-C)

Intervention Type: 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) + 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.

Group Type: EXPERIMENTAL

Emotional Support Plan - Clinician Guided (ESP-C)

Intervention Type: 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 - 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.

Group Type: EXPERIMENTAL

Emotional Support Plan - Self Guided (ESP-S)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organization for Autism Research

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Vanessa H. Bal, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa H Bal, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University - New Brunswick

Locations

Rutgers University

Piscataway, New Jersey, United States

Countries

United States

Other Identifiers

Pro2021000076

Identifier Type: -

Identifier Source: org_study_id