Traumatic Brain InjuryNCT04826068
Emotional Processing Intervention for Children With TBI
A study testing Emotional Processing in people with Traumatic Brain Injury, run by Kessler Foundation at 2 sites in United States.
Trial summary
Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Emotional Processing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 31 May 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages of 9 and 17. Speak and read English fluently.
- Healthy Volunteer or
- Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.
Who cannot join
- Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.
- History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
- Uncontrolled seizures or other unstable medical complications.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kessler Foundation
East Hanover, New Jersey, 07936
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury
Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).
Read the detailed description
The first stage of this project will evaluate the appropriateness of an emotional processing intervention modified for a pediatric population. The researchers will modify the intervention prior to the evaluation by the 15 typically developing children.
The second stage of the project will evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI. Emotional processing includes both facial affect recognition and social perception measures.
- Conditions
- Traumatic Brain Injury
- Being tested
- Emotional Processing
- Keywords
- Emotional Processing, Pediatric Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional ProcessingBehavioural
Processing Emotions of others based on photographs of faces
| Study group | Role | What they receive |
|---|---|---|
| Emotional Processing | Experimental | The intervention looks at emotional processing of face interpretation. Receives: Behavioral: Emotional Processing |
| Control intervention | Placebo comparator | The control group is seeing the same faces and are asked questions regarding them. Receives: Behavioral: Emotional Processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Identification Task
measure of facial affect recognition
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Lengenfelder, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826068
- Sponsor's protocol ID
- E-11220-20
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04826068
- Acronym / sponsor ID
- E-11220-20
- Conditions
- Traumatic Brain Injury
- Keywords
- Emotional Processing, Pediatric Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 1 Apr 2021 (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.
Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).
Detailed description
The first stage of this project will evaluate the appropriateness of an emotional processing intervention modified for a pediatric population. The researchers will modify the intervention prior to the evaluation by the 15 typically developing children.
The second stage of the project will evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI. Emotional processing includes both facial affect recognition and social perception measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Processing | Experimental | Behavioral: Emotional ProcessingThe intervention looks at emotional processing of face interpretation. |
| Control intervention | Placebo comparator | Behavioral: Emotional ProcessingThe control group is seeing the same faces and are asked questions regarding them. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages of 9 and 17. Speak and read English fluently.
- Healthy Volunteer or
- Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.
Key exclusion criteria (3 listed)
- Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.
- History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
- Uncontrolled seizures or other unstable medical complications.
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 ProcessingProcessing Emotions of others based on photographs of faces | Behavioural | Control intervention, Emotional Processing |
Primary outcome
Facial Identification Task
Time frame: 8 weeks
measure of facial affect recognition
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 6 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Processing in people with Traumatic Brain Injury, run by Kessler Foundation at 2 sites 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 3 inclusion and 3 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Facial Identification Task (time frame: 8 weeks). 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 6 Oct 2023.