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Developing Mental Health Supports for Autistic Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04926090
Recruitment Status : Active, not recruiting
First Posted : June 14, 2021
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Organization for Autism Research
Information provided by (Responsible Party):
Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey

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
Autism Spectrum Disorder Depression, Anxiety Behavioral: Emotional Support Plan - Clinician Guided (ESP-C) Behavioral: Emotional Support Plan - Self Guided (ESP-S) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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 : July 26, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926090


Locations
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United States, New Jersey
Rutgers University
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Organization for Autism Research
Investigators
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Principal Investigator: Vanessa H Bal, PhD Rutgers University - New Brunswick
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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: June 14, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Rutgers, The State University of New Jersey:
smartphone
ecological momentary intervention (EMI)
ecological momentary assessment (EMA)
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders