AutismNCT05341505
Outcomes of Emotion Regulation Therapy in Young Autistic Adults
A study testing Emotion Regulation Intervention in people with Autism, run by Michal Assaf at 1 site in United States.
Trial summary
This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Autism
- What is being tested?
- Emotion Regulation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 30 Jan 2023
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Autism Spectrum Disorder
- Ages 18-40
- Estimated full-scale IQ ≥ 80
- T score > 60 on either the externalizing or internalizing symptoms scores of either the Adult Behavior Checklist (ABC-L) or the Adult Self Report (ASR)
- Participation in previous study at the Olin Center ("Social Emotional Study"; E-HHC- 2018-0241)
Who cannot join
- Intellectual disability (estimated full scale IQ<80
- History of a significant head injury (severe concussion, hospitalization)
- History of neurosurgery
- History of epilepsy, stroke, MS, a neurodegenerative disorder, or any other neurological disorder
- A current major medical condition (e.g. cancer, heart failure)
- Current substance use (determined by urine screen done to all participants before each MRI scan)
- In-body metal implants (e.g. surgical clips, certain pacemakers) or history of exposure to metal shards or other MRI contraindications
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Institute of Living, Hartford Hospital
Hartford, Connecticut, 06106
Michal Assaf, MD, 860-545-7792, michal.assaf@hhchealth.org
Michal Assaf, MD
About this study
Official title: Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.
Read the detailed description
Five young adults with ASD with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (ER) intervention administered twice weekly for a total of 16 sessions. Participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.
- Conditions
- Autism
- Being tested
- Emotion Regulation Intervention
- Keywords
- Emotion regulation
- Medical subject headings
- Autistic Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation InterventionBehavioural
We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.
| Study group | Role | What they receive |
|---|---|---|
| ER intervention | Experimental | Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks. Receives: Behavioral: Emotion Regulation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Self Report (ASR)
Externalizing and internalizing composite scores
Measured: Baseline
Adult Self Report (ASR)
Externalizing and internalizing composite scores
Measured: 8 weeks
Adult Self Report (ASR)
Externalizing and internalizing composite scores
Measured: 2 months follow-up
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
Measured: Baseline
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
Measured: 8 weeks
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
Measured: 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start15 Jul 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michal Assaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michal Assaf, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341505
- Sponsor's protocol ID
- R-HHC-2017-0161
- Status last verified
- Oct 2022
- First submitted
- 24 Mar 2022
- Last updated
- 14 Oct 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 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05341505
- Acronym / sponsor ID
- R-HHC-2017-0161
- Conditions
- Autism
- Keywords
- Emotion regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Michal AssafUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 22 Apr 2022 (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.
This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.
Detailed description
Five young adults with ASD with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (ER) intervention administered twice weekly for a total of 16 sessions. Participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ER intervention | Experimental | Behavioral: Emotion Regulation InterventionCognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of Autism Spectrum Disorder
- Ages 18-40
- Estimated full-scale IQ ≥ 80
- T score > 60 on either the externalizing or internalizing symptoms scores of either the Adult Behavior Checklist (ABC-L) or the Adult Self Report (ASR)
- Participation in previous study at the Olin Center ("Social Emotional Study"; E-HHC- 2018-0241)
Key exclusion criteria (8 listed)
- Intellectual disability (estimated full scale IQ<80
- History of a significant head injury (severe concussion, hospitalization)
- History of neurosurgery
- History of epilepsy, stroke, MS, a neurodegenerative disorder, or any other neurological disorder
- A current major medical condition (e.g. cancer, heart failure)
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 |
|---|---|---|
| Emotion Regulation InterventionWe will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills. | Behavioural | ER intervention |
Primary outcome
Adult Self Report (ASR)
Time frame: Baseline
Externalizing and internalizing composite scores
Adult Self Report (ASR)
Time frame: 8 weeks
Externalizing and internalizing composite scores
Adult Self Report (ASR)
Time frame: 2 months follow-up
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
Time frame: Baseline
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
Time frame: 8 weeks
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
Time frame: 2 months follow-up
Externalizing and internalizing composite scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Intervention in people with Autism, run by Michal Assaf 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult Self Report (ASR) (time frame: Baseline). The study lists 6 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 14 Oct 2022.