Social Emotional Learning for Youth with Epilepsy

Overseen By Madeline Niemann, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Anti-seizure medications

Disqualifiers: Health burden, Mental wellbeing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since it involves participants with active epilepsy, it seems likely that you can continue your anti-seizure medication.

What data supports the effectiveness of the treatment Project Dream Team for youth with epilepsy?

A study showed that a child-centered, family-focused educational program significantly improved children's knowledge and self-perception of social skills related to managing epilepsy, suggesting that similar programs like Project Dream Team could be effective in enhancing social and emotional learning for youth with epilepsy. ^{1 2 3 4 5}

Is the Social Emotional Learning program for youth with epilepsy safe?

The research articles provided do not contain specific safety data for the Social Emotional Learning program or Project Dream Team for youth with epilepsy. ^{2 6 7 8 9}

How is the treatment Project Dream Team unique for youth with epilepsy?

Project Dream Team is unique because it focuses on social emotional learning, which aims to improve social skills and emotional well-being in youth with epilepsy, addressing areas like social competence and autonomy that are often overlooked in traditional epilepsy treatments. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Laurie Douglass, MD

Principal Investigator

Boston Medical Center, Department of Neurology

Eligibility Criteria

This trial is for young individuals aged 12 to 26 with epilepsy. It's designed to help them improve their social skills, emotional support, and overall quality of life. The study aims to evaluate a new program called Project Dream Team that could potentially be used widely.

Inclusion Criteria

The pediatric neurologist feels the patient would benefit from program participation

Able to read, write, and communicate in English at 3rd grade level

I have been diagnosed with epilepsy for at least 6 months.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Project Dream Team, a 5-session Social-Emotional Learning (SEL) curriculum designed for youth with epilepsy

4 months

5 sessions

Follow-up

Participants are monitored for changes in perceived social support, social-emotional skills, and epilepsy self-management strategies

4 months

Treatment Details

Interventions

• Project Dream Team

Trial Overview Project Dream Team is being tested in this trial. It's an innovative program developed from various scientific fields aiming to enhance the social support system of youth with epilepsy through knowledge, skills, and connections.

Participant Groups

Group I: Novel Social-Emotional Learning (SEL) curriculum Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Charles H. Hood Foundation

Collaborator

Trials

10

Recruited

1,100+

Findings from Research

Children and adolescents with medically refractory seizures report significant negative impacts on their quality of life, including excessive fatigue affecting their academic and social activities, emotional distress due to the unpredictability of seizures, profound social isolation, and fragmented learning experiences.

The study, which involved interviews with 49 participants aged 7-18, highlights the need for targeted clinical interventions and community programs to address these challenges and improve the overall quality of life for these youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I just want to be normal: a qualitative study exploring how children and adolescents view the impact of intractable epilepsy on their quality of life. Elliott, IM., Lach, L., Smith, ML.[2022]

The child-centered, family-focused educational program significantly improved knowledge and skills related to seizure management among children with epilepsy (n = 123) compared to a control group (n = 113) after 5 months.

Children in the experimental group also reported increased self-perceptions of social competency and better behavior, indicating positive psychosocial effects from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a program to enhance the competencies of children with epilepsy. Lewis, MA., Salas, I., de la Sota, A., et al.[2019]

In a study of children aged 4 to 18 with medically refractory epilepsy, factors such as the age of epilepsy onset, fewer antiepileptic drugs, and having unilobar epileptogenic foci were associated with higher IQ scores.

Family demands were found to moderate the relationship between the extent of epileptogenic foci and IQ, indicating that children with multilobar foci had lower IQ scores as family demands increased, while those with unilobar foci did not show this decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of family factors on IQ in pediatric medically refractory epilepsy. Puka, K., Smith, ML., Widjaja, E.[2019]

In a study of 13 children and adolescents with drug-resistant epilepsy, significant improvements in emotional and behavioral symptoms were observed after epilepsy surgery, with follow-ups extending up to 8.5 years.

The results indicated a sustained reduction in psychosocial impairment, suggesting that epilepsy surgery can lead to long-term benefits in the emotional well-being of young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of epilepsy surgery on emotions, behavior, and psychosocial impairment in children and adolescents with drug-resistant epilepsy: a prospective study. Hannan, S., Cross, JH., Scott, RC., et al.[2015]

In a study of 506 children aged 8 to 14 with epilepsy, it was found that their quality of life (QOL) is strongly influenced by their mental health and social support rather than the frequency of seizures.

The research highlights that while managing seizures is important, focusing on mental health and peer support is crucial for improving the overall perception of life quality in children with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children's perspective of quality of life in epilepsy. Fayed, N., Davis, AM., Streiner, DL., et al.[2023]

In a survey of 100 pediatric patients aged 6-18 on anticonvulsant treatment, 40% expressed fears about potential harm from their medication, particularly concerning neurological and psychiatric symptoms.

Among those who experienced adverse drug events, 82% reported feeling bothered by them, with significant emotional burdens and restrictions in school performance and leisure activities, highlighting the impact of these side effects on children's lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do pediatric patients perceive adverse drug events of anticonvulsant drugs? A survey. Neininger, MP., Woltermann, S., Jeschke, S., et al.[2021]

The selection of antiepileptic drugs for children with epilepsy is influenced by factors such as drug efficacy, formulation availability, dosing ease, and tolerability, particularly regarding behavioral side effects.

The review highlights that phenobarbital is associated with significant behavioral adverse events and should generally be avoided as a first or second treatment option for pediatric epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and psychiatric adverse events associated with antiepileptic drugs commonly used in pediatric patients. Glauser, TA.[2017]

In a study of 108 children aged 5 to 18 with epilepsy, 22.2% exhibited moderate to severe behavioral or emotional problems, highlighting the need for psychosocial support in their treatment.

Specific medical factors, such as the type of epilepsy and the use of multiple anticonvulsant medications, were linked to higher behavioral issues, particularly in social problems and aggression, indicating that these factors may influence the emotional well-being of children with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and emotional problems in children with epilepsy. Freilinger, M., Reisel, B., Reiter, E., et al.[2017]

A study involving 36 children with epilepsy and 35 healthy controls revealed that both groups attributed more shame to incompetence related to epilepsy compared to other illnesses, indicating a unique emotional response to epilepsy.

Despite similar patterns of shame and guilt attribution between children with epilepsy and healthy peers, the findings suggest that the emotional challenges faced by children with epilepsy are not solely due to excessive feelings of shame and guilt, highlighting the distinct psychological impact of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative emotions in children with newly diagnosed epilepsy. Oostrom, KJ., Schouten, A., Olthof, T., et al.[2019]

The systematic review analyzed 45 studies on social competence in children with epilepsy, revealing that social competence was not clearly defined across the research, indicating a gap in understanding this important area.

Most studies focused on social adjustment issues, highlighting the need for more research on specific social skills and socio-cognitive abilities to better understand the developmental pathways and protective factors for children with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social competence in children with epilepsy--a review. Rantanen, K., Eriksson, K., Nieminen, P.[2022]

Out of 38 trainees with epilepsy who completed social skills training, 39% were employed or in training at the time of follow-up, indicating some success in improving job readiness.

Despite 66% of participants feeling that the training boosted their self-confidence and social skills, 50% reported experiencing discrimination due to their epilepsy, highlighting the need for more targeted support and job placement programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Employment among young people with epilepsy. Carroll, D.[2019]

Over half (53%) of children and young people with epilepsy screened using the Strengths and Difficulties Questionnaire were found to have previously unrecognized mental health difficulties, highlighting the importance of early identification.

The PAVES pathway for early intervention received positive feedback from young people, parents, and clinicians, suggesting it is a feasible and acceptable approach that could improve long-term psychosocial outcomes for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot project of psychological services integrated into a pediatric epilepsy clinic: Psychology Adding Value - Epilepsy Screening (PAVES). George, C., Felix, SA., McLellan, A., et al.[2021]

Youth with epilepsy face challenges in social participation and autonomy, with parents often having different beliefs about managing daily life and medication, which can limit the youth's independence.

The Skills for Growing Up (SGU-Epilepsy) communication tool was found to be feasible for facilitating discussions about development and empowerment, but it did not show short-term benefits in enhancing autonomy or empowerment compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills for Growing Up-Epilepsy: An exploratory mixed methods study into a communication tool to promote autonomy and empowerment of youth with epilepsy. Hilberink, SR., van Ool, M., van der Stege, HA., et al.[2019]

In a study of 182 children with epilepsy aged 9-14, learning disability was identified as a significant predictor of lower academic self-concept, indicating that these children may struggle more with self-perception in their academic abilities compared to their peers without learning disabilities.

Children with epilepsy who also have learning disabilities reported a significantly lower quality of life, particularly in intrapersonal and interpersonal areas, highlighting the need for targeted support and educational interventions for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of learning disabilities on academic self-concept in children with epilepsy and on their quality of life. Brabcová, D., Zárubová, J., Kohout, J., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

I just want to be normal: a qualitative study exploring how children and adolescents view the impact of intractable epilepsy on their quality of life. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of a program to enhance the competencies of children with epilepsy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of family factors on IQ in pediatric medically refractory epilepsy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The effects of epilepsy surgery on emotions, behavior, and psychosocial impairment in children and adolescents with drug-resistant epilepsy: a prospective study. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Children's perspective of quality of life in epilepsy. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

How do pediatric patients perceive adverse drug events of anticonvulsant drugs? A survey. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Behavioral and psychiatric adverse events associated with antiepileptic drugs commonly used in pediatric patients. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Behavioral and emotional problems in children with epilepsy. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Negative emotions in children with newly diagnosed epilepsy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Social competence in children with epilepsy--a review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Employment among young people with epilepsy. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Pilot project of psychological services integrated into a pediatric epilepsy clinic: Psychology Adding Value - Epilepsy Screening (PAVES). [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Skills for Growing Up-Epilepsy: An exploratory mixed methods study into a communication tool to promote autonomy and empowerment of youth with epilepsy. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Effect of learning disabilities on academic self-concept in children with epilepsy and on their quality of life. [2019]