EpilepsyARGOSNCT07676539
Adapting the STRW Intervention for Adolescents and Young Adults With Epilepsy (ARGOS)
A study testing Surviving and Thriving in the Real World in people with Epilepsy and Epilepsy in Youth, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Epilepsy, Epilepsy in Youth, Activities, Daily Living
- What is being tested?
- Surviving and Thriving in the Real World
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with epilepsy at least 1 year ago,
- enrolled in 9th-12th grade (i.e., 14-18 years old at time of enrollment)
- deficits in adaptive functioning per caregiver report (i.e., standard score below 90 on either the ABAS-3 Practical Domain or General Adaptive Composite [GAC]),
- not planning to wean off anti-seizure medication (ASM) within the intervention timeframe,
- and family's primary language is English.
Who cannot join
- Parent- or clinician-reported history in the adolescent/young adult of:
- history of developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ<70),
- severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months),
- currently on the ketogenic diet,
- and history of epilepsy surgery in the past year.
- Clinician-reported diagnosis in the adolescent/young adult of:
Show all 11Show fewer
- one or more episodes of status epilepticus within the 24 weeks prior to enrollment
- treatable causes of seizures (for example, identified etiologies including metabolic, neoplastic or active infectious origin),
- a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome),
- a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders),
- non-epileptic events/seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Adolescents With Epilepsy Reaching Goals Through Optimal Self-Management
The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. The main questions it aims to answer are:
- Is STRW an acceptable, feasible, and satisfactory intervention for teens/young adults and their caregivers?
- Does STRW improve daily living skills (e.g., cooking, laundry, money management) for teens and young adults with epilepsy?
Read more
This is a nonrandomized pilot trial and all participants who enroll will:
- Participate in weekly caregiver/teen dyads ( approximately 60 minutes) focused on improving daily living skills with a trained therapist for 15 weeks.
- Participate in weekly caregiver groups (approximately 90 minutes) focused on supporting caregivers in coaching their teens in daily living skills development led by 2 trained therapists for 14 of the 15 intervention weeks.
- Complete measures of adaptive functioning (to evaluate daily living skills; parent and teen-report) at the start of the study and post-intervention. Additional measures will also be collected.
- Have the option to complete post-intervention interviews to provide feedback on the intervention components.
Read the detailed description
Epilepsy is a common childhood neurological condition and disproportionately affects adolescents and young adults (AYAs) compared to younger children. An estimated 1.1 million AYAs with epilepsy will become adults and with this transition to adulthood, youth with epilepsy often have increased challenges, including social stigma, reduced health-related quality of life, and perceived lack of independence. Some of these challenges may be related to deficits in executive functioning (EF), and as many as 30-50% of AYAs with epilepsy demonstrate EF deficits. EF has also been shown to impact adaptive functioning. Daily living skills (DLS), a component of adaptive functioning, are essential for managing independent living into adulthood. Age-appropriate DLS are linked to better adult outcomes in youth, including finding and keeping a job, attending college, and living independently. However, research has shown that even with relatively normal cognitive abilities, youth with epilepsy have demonstrated poorer adaptive skills compared to same-age peers, and interventions targeting the acquisition of DLS may be an important mechanism for closing this gap. Surviving and Thriving in the Real World (STRW) is a 15-week evidence-based DLS intervention developed originally for adolescents with autism without an intellectual disability (ID; IQ>70) that has shown promising results for improving DLS. Given the overlap of deficits in adaptive and executive functioning, STRW may be a useful intervention for adolescents with epilepsy to improve DLS in a structured and supported program prior to their transition to adulthood. In the current study, the investigators will deliver STRW for adolescents with epilepsy and test the effectiveness of the virtual intervention with families recruited from Cincinnati Children's Hospital Medical Center (CCHMC). Given the emphasis on increasing DLS for adolescents with challenges in adaptive functioning, adolescents will be screened based on a parent measure of adaptive functioning skills called the Adaptive Behavior Assessment System, Third Edition (ABAS-3) prior to intervention enrollment. The aim is to assess the satisfaction and acceptability of the STRW intervention for caregivers and adolescents completing the intervention and to determine the impact on adaptive functioning from pre- to post-treatment. The intervention will enroll high schoolers (i.e., 9th-12th graders) to examine the impact of the intervention on youth prior to the transition to adulthood. The investigators expect that adolescents and caregivers will rate STRW as satisfactory and acceptable and youth who complete the STRW intervention will demonstrate improvements on the caregiver-reported primary DLS assessment (ABAS-3) from pre-to post-treatment. Adolescent-reported DLS will also be explored.
- Conditions
- Epilepsy, Epilepsy in Youth, Activities, Daily Living
- Being tested
- Surviving and Thriving in the Real World
- Keywords
- Surviving and Thriving in the Real World, STRW, ARGOS, Daily Living Skills
- Medical subject headings
- Epilepsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surviving and Thriving in the Real WorldBehavioural
Also called STRW
The Surviving and Thriving in the Real World (STRW) intervention consists of 15 weekly caregiver-teen dyad sessions and 14 concurrent weekly caregiver group sessions delivered via Microsoft Teams. Daily Living Skills (DLS) targeted in the intervention include: morning routine, laundry, kitchen/cooking, grocery shopping, and money management. Evidence-based strategies are utilized to facilitate acquisition, mastery, and generalization of specific DLS at home and in the community. During dyad sessions, teens work on DLS in their home environment and will receive coaching and instruction from both their caregiver and the therapist. During caregiver group sessions, the therapist will discuss the content of dyad sessions and engage in problem solving with each caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Surviving and Thriving in the Real World | Experimental | Participants in this single arm receive the study intervention (Surviving and Thriving in the Real World (STRW)). Receives: Behavioral: Surviving and Thriving in the Real World |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants.
Measured: Enrollment
Retention Rate
Retention will be calculated by dividing the number of participants who completed the study at post-treatment by the number of eligible participants enrolled.
Measured: From enrollment to 1-month post intervention (up to approximately 23 weeks)
Caregiver Satisfaction and Acceptability
The study-specific satisfaction and acceptability surveys will be sent to caregivers after each caregiver group and dyad session attended in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.
Measured: Weekly during the intervention (Up to 15 weeks)
Adolescent/Young Adult Satisfaction and Acceptability
The study-specific satisfaction and acceptability surveys will be sent to adolescent and young adult participants after each dyad session completed in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.
Measured: Weekly during the intervention (Up to 15 weeks)
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Other (Caregiver) Form, Practical Domain Standard Score
The ABAS-3 Adult-Other (Caregiver) Form, Practical Domain Standard Score will be used as a primary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.
Measured: Post-Intervention (Up to 4 weeks Post-Intervention)
Secondary outcomes (1)
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Self Form, Practical Domain Standard Score
The ABAS-3 Adult-Self Form, Practical Domain Standard Score will be used as a secondary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.
Measured: Post-Intervention (Up to 4 weeks Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start3 Dec 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed study will involve a single site nonrandomized pilot trial using pre-post design to assess the acceptability, feasibility, and satisfaction of the Surviving and Thriving in the Real World (STRW) intervention with teens and young adults with epilepsy and determine the impact of STRW on daily living skills.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Avani Modi, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676539
- Sponsor's protocol ID
- 2025-0579
- Other IDs
- 5T32HD068223-13
- Acronym
- ARGOS
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be made available. Given the very small sample size of this pilot study, there is a substantial risk of participant re-identification even after de-identification procedures, and therefore data sharing is not appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescents With Epilepsy Reaching Goals Through Optimal Self-Management
- ClinicalTrials.gov ID
- NCT07676539
- Acronym / sponsor ID
- ARGOS / 2025-0579
- Conditions
- Epilepsy, Epilepsy in Youth, Activities, Daily Living
- Keywords
- Surviving and Thriving in the Real World, STRW, ARGOS, Daily Living Skills
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 30 Jun 2026 (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.
The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. The main questions it aims to answer are:
- Is STRW an acceptable, feasible, and satisfactory intervention for teens/young adults and their caregivers?
- Does STRW improve daily living skills (e.g., cooking, laundry, money management) for teens and young adults with epilepsy?
This is a nonrandomized pilot trial and all participants who enroll will:
- Participate in weekly caregiver/teen dyads ( approximately 60 minutes) focused on improving daily living skills with a trained therapist for 15 weeks.
- Participate in weekly caregiver groups (approximately 90 minutes) focused on supporting caregivers in coaching their teens in daily living skills development led by 2 trained therapists for 14 of the 15 intervention weeks.
- Complete measures of adaptive functioning (to evaluate daily living skills; parent and teen-report) at the start of the study and post-intervention. Additional measures will also be collected.
- Have the option to complete post-intervention interviews to provide feedback on the intervention components.
Detailed description
Epilepsy is a common childhood neurological condition and disproportionately affects adolescents and young adults (AYAs) compared to younger children. An estimated 1.1 million AYAs with epilepsy will become adults and with this transition to adulthood, youth with epilepsy often have increased challenges, including social stigma, reduced health-related quality of life, and perceived lack of independence. Some of these challenges may be related to deficits in executive functioning (EF), and as many as 30-50% of AYAs with epilepsy demonstrate EF deficits. EF has also been shown to impact adaptive functioning. Daily living skills (DLS), a component of adaptive functioning, are essential for managing independent living into adulthood. Age-appropriate DLS are linked to better adult outcomes in youth, including finding and keeping a job, attending college, and living independently. However, research has shown that even with relatively normal cognitive abilities, youth with epilepsy have demonstrated poorer adaptive skills compared to same-age peers, and interventions targeting the acquisition of DLS may be an important mechanism for closing this gap. Surviving and Thriving in the Real World (STRW) is a 15-week evidence-based DLS intervention developed originally for adolescents with autism without an intellectual disability (ID; IQ>70) that has shown promising results for improving DLS. Given the overlap of deficits in adaptive and executive functioning, STRW may be a useful intervention for adolescents with epilepsy to improve DLS in a structured and supported program prior to their transition to adulthood. In the current study, the investigators will deliver STRW for adolescents with epilepsy and test the effectiveness of the virtual intervention with families recruited from Cincinnati Children's Hospital Medical Center (CCHMC). Given the emphasis on increasing DLS for adolescents with challenges in adaptive functioning, adolescents will be screened based on a parent measure of adaptive functioning skills called the Adaptive Behavior Assessment System, Third Edition (ABAS-3) prior to intervention enrollment. The aim is to assess the satisfaction and acceptability of the STRW intervention for caregivers and adolescents completing the intervention and to determine the impact on adaptive functioning from pre- to post-treatment. The intervention will enroll high schoolers (i.e., 9th-12th graders) to examine the impact of the intervention on youth prior to the transition to adulthood. The investigators expect that adolescents and caregivers will rate STRW as satisfactory and acceptable and youth who complete the STRW intervention will demonstrate improvements on the caregiver-reported primary DLS assessment (ABAS-3) from pre-to post-treatment. Adolescent-reported DLS will also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed study will involve a single site nonrandomized pilot trial using pre-post design to assess the acceptability, feasibility, and satisfaction of the Surviving and Thriving in the Real World (STRW) intervention with teens and young adults with epilepsy and determine the impact of STRW on daily living skills.
| Arm | Type | Receives |
|---|---|---|
| Surviving and Thriving in the Real World | Experimental | Behavioral: Surviving and Thriving in the Real WorldParticipants in this single arm receive the study intervention (Surviving and Thriving in the Real World (STRW)). |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- diagnosed with epilepsy at least 1 year ago,
- enrolled in 9th-12th grade (i.e., 14-18 years old at time of enrollment)
- deficits in adaptive functioning per caregiver report (i.e., standard score below 90 on either the ABAS-3 Practical Domain or General Adaptive Composite [GAC]),
- not planning to wean off anti-seizure medication (ASM) within the intervention timeframe,
- and family's primary language is English.
Key exclusion criteria (11 listed)
- Parent- or clinician-reported history in the adolescent/young adult of:
- Clinician-reported diagnosis in the adolescent/young adult of:
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 |
|---|---|---|
| Surviving and Thriving in the Real WorldAlso: STRWThe Surviving and Thriving in the Real World (STRW) intervention consists of 15 weekly caregiver-teen dyad sessions and 14 concurrent weekly caregiver group sessions delivered via Microsoft Teams. Daily Living Skills (DLS) targeted in the intervention include: morning routine, laundry, kitchen/cooking, grocery shopping, and money management. Evidence-based strategies are utilized to facilitate acquisition, mastery, and generalization of specific DLS at home and in the community. During dyad sessions, teens work on DLS in their home environment and will receive coaching and instruction from both their caregiver and the therapist. During caregiver group sessions, the therapist will discuss the content of dyad sessions and engage in problem solving with each caregiver. | Behavioural | Surviving and Thriving in the Real World |
Primary outcome
Enrollment Rate
Time frame: Enrollment
Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants.
Retention Rate
Time frame: From enrollment to 1-month post intervention (up to approximately 23 weeks)
Retention will be calculated by dividing the number of participants who completed the study at post-treatment by the number of eligible participants enrolled.
Caregiver Satisfaction and Acceptability
Time frame: Weekly during the intervention (Up to 15 weeks)
The study-specific satisfaction and acceptability surveys will be sent to caregivers after each caregiver group and dyad session attended in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.
Adolescent/Young Adult Satisfaction and Acceptability
Time frame: Weekly during the intervention (Up to 15 weeks)
The study-specific satisfaction and acceptability surveys will be sent to adolescent and young adult participants after each dyad session completed in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Other (Caregiver) Form, Practical Domain Standard Score
Time frame: Post-Intervention (Up to 4 weeks Post-Intervention)
The ABAS-3 Adult-Other (Caregiver) Form, Practical Domain Standard Score will be used as a primary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.
1 secondary outcome
Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Self Form, Practical Domain Standard Score
Time frame: Post-Intervention (Up to 4 weeks Post-Intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- STRW WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be made available. Given the very small sample size of this pilot study, there is a substantial risk of participant re-identification even after de-identification procedures, and therefore data sharing is not appropriate.
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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.
Avani Modi, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surviving and Thriving in the Real World in people with Epilepsy and Epilepsy in Youth, run by Children's Hospital Medical Center, Cincinnati 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 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Enrollment Rate (time frame: Enrollment). The study lists 5 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 8 Jul 2026.