Psychological DistressNCT04460677
ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19
A study testing Emotional Support Plan and Daily Monitoring in people with Psychological Distress and Stress, Psychological, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Stress, Psychological, Autism Spectrum Disorder
- What is being tested?
- Emotional Support Plan and Daily Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 9 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals who are younger than 18 years old or who does not have diagnosis of ASD will excluded from the study as the purpose of the current research is to evaluate the validity of ESPs in adults with autism.
- Adults who are unable to understand English will be excluded because the instruments being investigated are currently only validated in English and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides English.
- Subjects without access to a compatible iOS and Android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. Individuals will not be excluded from the study based on race, ethnicity or gender.
- Subjects who have a verbal IQ below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention.
- If the PI's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).
- Being tested
- Emotional Support Plan, Daily Monitoring
- Keywords
- smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)
- Medical subject headings
- Stress, Psychological, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Support PlanBehavioural
The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.
Daily MonitoringBehavioural
The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Support Plan (ESP) + Weekly Monitoring | Experimental | This will involve weekly assessments without prompting to use the plan. Receives: Behavioral: Emotional Support Plan |
| Emotional Support Plan (ESP) + 4x Daily Monitoring | Experimental | Participants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt Receives: Behavioral: Emotional Support Plan; Behavioral: Daily Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased distress on Patient Health Questionnaire (PHQ-9)
The PHQ-9, assessed weekly, 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: 8 week study period
Decreased distress on EMA reports
EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.
Measured: 8 week study period
Decreased 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: 8 week study period
Secondary outcomes (1)
Adult Self Report (ASR)
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.
Measured: 8 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start12 Aug 2020
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460677
- Sponsor's protocol ID
- Pro2020001593
- Status last verified
- Aug 2022
- First submitted
- 6 Jul 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)
- ClinicalTrials.gov ID
- NCT04460677
- Acronym / sponsor ID
- Pro2020001593
- Keywords
- smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Support Plan (ESP) + Weekly Monitoring | Experimental | Behavioral: Emotional Support PlanThis will involve weekly assessments without prompting to use the plan. |
| Emotional Support Plan (ESP) + 4x Daily Monitoring | Experimental | Behavioral: Emotional Support Plan, Behavioral: Daily MonitoringParticipants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Individuals who are younger than 18 years old or who does not have diagnosis of ASD will excluded from the study as the purpose of the current research is to evaluate the validity of ESPs in adults with autism.
- Adults who are unable to understand English will be excluded because the instruments being investigated are currently only validated in English and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides English.
- Subjects without access to a compatible iOS and Android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. Individuals will not be excluded from the study based on race, ethnicity or gender.
- Subjects who have a verbal IQ below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention.
- If the PI's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Support PlanThe Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. | Behavioural | Emotional Support Plan (ESP) + 4x Daily Monitoring, Emotional Support Plan (ESP) + Weekly Monitoring |
| Daily MonitoringThe daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed. | Behavioural | Emotional Support Plan (ESP) + 4x Daily Monitoring |
Primary outcome
Decreased distress on Patient Health Questionnaire (PHQ-9)
Time frame: 8 week study period
The PHQ-9, assessed weekly, 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.
Decreased distress on EMA reports
Time frame: 8 week study period
EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.
Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: 8 week study 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.
1 secondary outcome
Adult Self Report (ASR)
Time frame: 8 week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Support Plan and Daily Monitoring in people with Psychological Distress and Stress, Psychological, 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 0 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?
Decreased distress on Patient Health Questionnaire (PHQ-9) (time frame: 8 week study 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?
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.