EpilepsyPhase 2NCT02925663
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
A Phase 2 study testing EFI-E in people with Epilepsy, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
The purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- EFI-E
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2016to 28 Jun 2018
- Phase
- Phase 2
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 13-17 years
- Diagnosis of epilepsy
- Have at least two subclinical (>1 SD; T score between 60-65) or one clinically-elevated BRIEF subscale (T score > 65)
- Primary caregiver consent and adolescent assent to participate in study
Who cannot join
- Diagnosis of non-epilepsy medical disorders requiring daily medications with the exception of asthma and/or allergies
- Diagnosis of significant developmental disorders (e.g. Autism)
- Inability to read and speak English due to the questionnaires and intervention only been developed in English
- Family lives greater than 100 miles away from CCHMC
- If patient is planning to wean from their antiepileptic medication within the next 6 months
About this study
The purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E).
Read the detailed description
Epilepsy is a common childhood condition affecting approximately 326,000 youth in the United States. Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and poor treatment adherence. Studies have shown that one potential reason for these poor outcomes are deficits in executive functioning (EF), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation and working memory. EF deficits have been documented in 1/3 of youth with epilepsy, which is 3 times the prevalence in healthy youth. Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and promoting optimal functioning in adolescents with epilepsy; however none exists for this vulnerable population. The aim of the current study is to establish the feasibility, accessibility, acceptability, and preliminary effects of an individually-tailored intervention to improve EF in adolescents with epilepsy (Executive Functioning Intervention-Epilepsy; EFI-E). Thirty participants will be recruited who have at least one clinically-elevated EF subscale or at least two at-risk subscale scores (> 1 standard deviation above the mean) on the parent Behavior Rating Inventory of Executive Function (BRIEF®)) to qualify for the EFI-E. EFI-E will consist of 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals. Baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial. Participants will be in the trial for 9 months.
- Conditions
- Epilepsy
- Being tested
- EFI-E
- Keywords
- executive functioning
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFI-EBehavioural
This is 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals.
| Study group | Role | What they receive |
|---|---|---|
| EFI-E | Experimental | 10-session web-based modules to teach about executive functioning with videoconferencing with a therapist Receives: Behavioral: EFI-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
Measured: 3-months
Secondary outcomes (3)
Adherence: SimpleMed Pillboxes or MEMS TrackCaps
Measured: 3-months
Quality of life: PedsQL Epilepsy Module
Measured: 3-months
Seizures
A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start10 Oct 2016
- Primary completion4 Jan 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients are receiving an executive functioning intervention in an open trial design-pre-post
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925663
- Sponsor's protocol ID
- R21HD083335
- Status last verified
- Jul 2018
- First submitted
- 3 Oct 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gutierrez-Colina AM, Clifford L, Wade SL, Modi AC. Uncovering Key Elements of an Executive Functioning Intervention in Adolescents: Epilepsy Journey. Clin Pract Pediatr Psychol. 2022 Jun;10(2):150-163. doi: 10.1037/cpp0000410. Epub 2021 Sep 2.
PubMed 35873364
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
- ClinicalTrials.gov ID
- NCT02925663
- Acronym / sponsor ID
- R21HD083335
- Conditions
- Epilepsy
- Keywords
- executive functioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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 establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E).
Detailed description
Epilepsy is a common childhood condition affecting approximately 326,000 youth in the United States. Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and poor treatment adherence. Studies have shown that one potential reason for these poor outcomes are deficits in executive functioning (EF), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation and working memory. EF deficits have been documented in 1/3 of youth with epilepsy, which is 3 times the prevalence in healthy youth. Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and promoting optimal functioning in adolescents with epilepsy; however none exists for this vulnerable population. The aim of the current study is to establish the feasibility, accessibility, acceptability, and preliminary effects of an individually-tailored intervention to improve EF in adolescents with epilepsy (Executive Functioning Intervention-Epilepsy; EFI-E). Thirty participants will be recruited who have at least one clinically-elevated EF subscale or at least two at-risk subscale scores (> 1 standard deviation above the mean) on the parent Behavior Rating Inventory of Executive Function (BRIEF®)) to qualify for the EFI-E. EFI-E will consist of 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals. Baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial. Participants will be in the trial for 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are receiving an executive functioning intervention in an open trial design-pre-post
| Arm | Type | Receives |
|---|---|---|
| EFI-E | Experimental | Behavioral: EFI-E10-session web-based modules to teach about executive functioning with videoconferencing with a therapist |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 13-17 years
- Diagnosis of epilepsy
- Have at least two subclinical (>1 SD; T score between 60-65) or one clinically-elevated BRIEF subscale (T score > 65)
- Primary caregiver consent and adolescent assent to participate in study
Key exclusion criteria (5 listed)
- Diagnosis of non-epilepsy medical disorders requiring daily medications with the exception of asthma and/or allergies
- Diagnosis of significant developmental disorders (e.g. Autism)
- Inability to read and speak English due to the questionnaires and intervention only been developed in English
- Family lives greater than 100 miles away from CCHMC
- If patient is planning to wean from their antiepileptic medication within the next 6 months
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 |
|---|---|---|
| EFI-EThis is 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals. | Behavioural | EFI-E |
Primary outcome
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 3-months
3 secondary outcomes
Adherence: SimpleMed Pillboxes or MEMS TrackCaps
Time frame: 3-months
Quality of life: PedsQL Epilepsy Module
Time frame: 3-months
Seizures
Time frame: 3-months
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 5 Feb 2020.
- Derived from this study: PubMed 35873364Gutierrez-Colina AM, Clifford L, Wade SL, Modi AC. Uncovering Key Elements of an Executive Functioning Intervention in Adolescents: Epilepsy Journey. Clin Pract Pediatr Psychol. 2022 Jun;10(2):150-163. doi: 10.1037/cpp0000410. Epub 2021 Sep 2.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EFI-E in people with Epilepsy, run by Children's Hospital Medical Center, Cincinnati.
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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF) (time frame: 3-months). 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 NCT02925663, which also lists 1 linked publication.
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 5 Feb 2020.