## Protocol Section
### Identification Module
**NCT ID:** NCT06427967

**Brief Title:** A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

**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

#### Organization Study ID Info
**ID:** H-43875
#### Organization
**Class:** OTHER
**Full Name:** Boston Medical Center
#### Secondary ID Infos
**Domain:** Charles F. Hood Foundation
**ID:** 4301210001
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Charles H. Hood Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** One-group pretest-posttest

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE.

**Intervention Names:**

- Behavioral: Project Dream Team

**Label:** Novel Social-Emotional Learning (SEL) curriculum

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Novel Social-Emotional Learning (SEL) curriculum

**Description:** 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.

**Name:** Project Dream Team

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** The Youth Thrive (YT) Framework Survey Part 2: Youth Resilience, Cognitive and Social-Emotional Competence subscales will be used to assess this outcome. 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 greater depth of knowledge, higher mastery over key skills and more frequent use of prosocial behaviors.

**Measure:** Change in social emotional skills and behaviors

**Time Frame:** Baseline, 4 months

**Description:** This outcome will be assessed using the 25 subscale items from the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65). The responses are Likert scale-rated from 0 to 5 for positively phrased items, and inversely scored for negatively phrased items. Each subscale will be scored individually and also totaled for a single composite score. Higher scores indicate higher use of effective epilepsy self-management strategies.

**Measure:** Change in leveraging social support for epilepsy self management

**Time Frame:** Baseline, 4 months

#### Primary Outcomes

**Description:** Number of sessions attended per participant.

**Measure:** Feasibility of study processes

**Time Frame:** 4 months

**Description:** A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable.

**Measure:** Acceptability of the intervention

**Time Frame:** 4 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Change in perceived social support (PSS)

**Time Frame:** Baseline, 4 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

**Maximum Age:** 26 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** laurie.douglass@bmc.org

**Name:** Laurie Douglass, MD

**Phone:** (617) 414-4590

**Role:** CONTACT

**Contact 2:**

**Email:** kiya.walker@bmc.org

**Name:** Kiya Walker, MPH

**Phone:** (617) 414-4588

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Email:** laurie.douglass@bmc.org

- **Name:** Laurie Douglass, MD

- **Phone:** 617-414-4590

- **Role:** CONTACT

***Contact 2:***

- **Email:** kiya.walker@bmc.org

- **Name:** Kiya Walker, MPH

- **Role:** CONTACT

**Country:** United States

**Facility:** Boston Medical Center, Neurology and remote

**State:** Massachusetts

**Zip:** 02118

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Center, Department of Neurology

**Name:** Laurie Douglass, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M7983

- Name: Epilepsy

- Relevance: HIGH

- As Found: Epilepsy

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004827

- Term: Epilepsy

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
