EpilepsyNCT06427967
A Novel Social Emotional Learning Curriculum for Youth With Epilepsy
A study testing Project Dream Team in people with Epilepsy, run by Boston Medical Center at 1 site in United States.
Trial summary
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Read more about this study
- Who is it for?
- Ages 12 to 26 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Project Dream Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 30 Jul 2025
- 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 12 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Able to read, write, and communicate in English at 3rd grade level
- Active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication)
- Epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment
- The pediatric neurologist feels the patient would benefit from program participation.
- Able to consistently join meetings on Zoom with functional audio and video reception
Who cannot join
- During the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center, Neurology and remote
Boston, Massachusetts, 02118
About this study
Official title: Beyond Watching and Waiting: A Pilot Study of a Novel Social Emotional Learning Curriculum-Based Intervention Designed for Youth With Epilepsy at Increased Risk of Future Mental Illness
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor.
Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically.
Read more
The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored.
The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.
- Conditions
- Epilepsy
- Being tested
- Project Dream Team
- Keywords
- Youth with epilepsy (YWE), Positive Youth Development, Social-Emotional Learning, Social Ecological Model, Youth Thrive Framework, Perceived Social Support, Health-Related Quality of Life, Adult Epilepsy Self-Management Measurement Instrument
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Dream TeamBehavioural
Five total sessions, 60-minutes each, with one session every 7 days (+/- 21 days between sessions), Session activities include discussion prompts, interactive learning methods, skill rehearsals, mindfulness / somatic exercises and lecture slides facilitated by a trained facilitator.
| Study group | Role | What they receive |
|---|---|---|
| Novel Social-Emotional Learning (SEL) curriculum | Experimental | Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE. Receives: Behavioral: Project Dream Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study processes
Number of sessions attended per participant.
Measured: 4 months
Acceptability of the intervention
A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable.
Measured: 4 months
Secondary outcomes (1)
Change in perceived social support (PSS)
This outcome will be assessed with the Youth Thrive (YT) Framework Survey Part 1: Social Connections and Concrete Supports combine subscales. Each YT subscale includes 10 to 16 individual Likert scale questions. Scores are generated by assigning values of 1 to 5 to the Likert scale (1 = not at all like me, 5 = very much like me) for 'positive items' and an inverse value scale for 'negative items' and then totalling all the items within the subscale. Higher total scores indicate a higher level of PSS.
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start16 Jul 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-group pretest-posttest
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Charles H. Hood Foundation
- Responsible party
- Sponsor
- Investigators
- Laurie Douglass, MD, Principal investigator, Boston Medical Center, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427967
- Sponsor's protocol ID
- H-43875
- Other IDs
- 4301210001
- Status last verified
- Aug 2025
- First submitted
- 20 May 2024
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Watching and Waiting: A Pilot Study of a Novel Social Emotional Learning Curriculum-Based Intervention Designed for Youth With Epilepsy at Increased Risk of Future Mental Illness
- ClinicalTrials.gov ID
- NCT06427967
- Acronym / sponsor ID
- H-43875
- Conditions
- Epilepsy
- Keywords
- Youth with epilepsy (YWE), Positive Youth Development, Social-Emotional Learning, Social Ecological Model, Youth Thrive Framework, Perceived Social Support, Health-Related Quality of Life, Adult Epilepsy Self-Management Measurement Instrument
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Charles H. Hood Foundation
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 24 May 2024 (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.
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor.
Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically.
The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored.
The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-group pretest-posttest
| Arm | Type | Receives |
|---|---|---|
| Novel Social-Emotional Learning (SEL) curriculum | Experimental | Behavioral: Project Dream TeamParticipants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE. |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Able to read, write, and communicate in English at 3rd grade level
- Active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication)
- Epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment
- The pediatric neurologist feels the patient would benefit from program participation.
- Able to consistently join meetings on Zoom with functional audio and video reception
Key exclusion criteria (1 listed)
- During the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will 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 |
|---|---|---|
| Project Dream TeamFive total sessions, 60-minutes each, with one session every 7 days (+/- 21 days between sessions), Session activities include discussion prompts, interactive learning methods, skill rehearsals, mindfulness / somatic exercises and lecture slides facilitated by a trained facilitator. | Behavioural | Novel Social-Emotional Learning (SEL) curriculum |
Primary outcome
Feasibility of study processes
Time frame: 4 months
Number of sessions attended per participant.
Acceptability of the intervention
Time frame: 4 months
A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable.
1 secondary outcome
Change in perceived social support (PSS)
Time frame: Baseline, 4 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 3 Aug 2025.
- Individual participant dataSharing planned: No
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Epilepsy
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.
Laurie Douglass, MD principal investigator
Boston Medical Center, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Dream Team in people with Epilepsy, run by Boston Medical Center 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 1 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 3 Aug 2025. 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?
Feasibility of study processes (time frame: 4 months). The study lists 2 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 3 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.