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Autism Spectrum DisorderNCT04926090

Developing Mental Health Supports for Autistic Students

A study testing Emotional Support Plan - Clinician Guided (ESP-C) and Emotional Support Plan - Self Guided (ESP-S) in people with Autism Spectrum Disorder and Depression, Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Autism Spectrum Disorder, Depression, Anxiety
What is being tested?
Emotional Support Plan - Clinician Guided (ESP-C) and Emotional Support Plan - Self Guided (ESP-S)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
26 Jul 2021to 27 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers University

    Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Emotional Support Plan - Clinician Guided (ESP-C), Emotional Support Plan - Self Guided (ESP-S)
Keywords
smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)
Medical subject headings
Autism Spectrum Disorder, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Support Plan - Clinician Guided (ESP-C)Behavioural

    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)Behavioural

    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.

Study groups in NCT04926090
Study groupRoleWhat they receive
Emotional Support Plan - Clinician Guided (ESP-C) + (Bi)Weekly MonitoringExperimentalThis 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.
Receives: Behavioral: Emotional Support Plan - Clinician Guided (ESP-C)
Emotional Support Plan - Clinician Guided (ESP-C) + 4x Daily MonitoringExperimentalParticipants 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.
Receives: Behavioral: Emotional Support Plan - Clinician Guided (ESP-C)
Emotional Support Plan - Self Guided (ESP-S) + 4x Daily MonitoringExperimentalParticipants 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.
Receives: Behavioral: Emotional Support Plan - Self Guided (ESP-S)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 week monitoring period

  2. 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.

    Measured: 15 week monitoring period

  3. 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.

    Measured: 15 week monitoring period

Secondary outcomes (4)

  1. 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.

    Measured: 15 week monitoring period

  2. 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.

    Measured: 15 week monitoring period

  3. 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.

    Measured: 15 week monitoring period

  4. 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.

    Measured: 15 week monitoring period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start26 Jul 2021
  3. Primary completion27 Jul 2022
  4. Study completion27 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926090
Sponsor's protocol ID
Pro2021000076
Status last verified
Aug 2022
First submitted
8 Jun 2021
Last updated
10 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Support Plan - Clinician Guided (ESP-C) and Emotional Support Plan - Self Guided (ESP-S) in people with Autism Spectrum Disorder and Depression, Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in distress on Patient Health Questionnaire (PHQ-9) (time frame: 15 week monitoring period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04926090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.

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