RECRUITING

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth. Participants will attend 4 study visits: * A clinical and trauma assessment visit * A testing day that may include cognitive testing, surveys, and an MRI. * An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition * An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition

Official Title

Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder

Quick Facts

Study Start:2024-07-16

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06341413

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 15-18 years old, inclusive * Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures * Able to lie still on their back for up to 1 hour * Must not be pregnant * Must agree not to participate in any other interventional clinical trials during the duration of the study * Must be willing to comply with all study procedures * Agree to have study visits video and/or audio recorded, including consent visit, clinical assessments (for staff training) and in-laboratory sleep visits (recording deleted within one month of study visit). * A primary parent or guardian is willing participate in the study and to provide informed consent * Are fluent in or predominantly speaking and reading in English	* Caregiver or adolescent is unwilling or unable to give adequate informed consent. * Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation. * Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant. * Participation in the last 30 days in a clinical study involving an investigational drug * MRI contraindication * Claustrophobia or inability lie still in the scanner after practice MRI sessions. * Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not an exclusion. Would present a serious risk to others as established through clinical interview and contact with treating physician. * Neurodevelopmental disorders such as autism spectrum disorder * Intellectual Disability (IQ less than 70, per self-report) * Currently impaired by any medical condition that would prevent study participation * Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and/or impairments in concentration. * Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC/PTSD youth) * Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep. * Possible pregnancy * No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia. * Current diagnosis of a sleep disorder (self-report). * Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc.

Inclusion Criteria

Exclusion Criteria

* Aged 15-18 years old, inclusive
* Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures
* Able to lie still on their back for up to 1 hour
* Must not be pregnant
* Must agree not to participate in any other interventional clinical trials during the duration of the study
* Must be willing to comply with all study procedures
* Agree to have study visits video and/or audio recorded, including consent visit, clinical assessments (for staff training) and in-laboratory sleep visits (recording deleted within one month of study visit).
* A primary parent or guardian is willing participate in the study and to provide informed consent
* Are fluent in or predominantly speaking and reading in English

* Caregiver or adolescent is unwilling or unable to give adequate informed consent.
* Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation.
* Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant.
* Participation in the last 30 days in a clinical study involving an investigational drug
* MRI contraindication
* Claustrophobia or inability lie still in the scanner after practice MRI sessions.
* Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not an exclusion. Would present a serious risk to others as established through clinical interview and contact with treating physician.
* Neurodevelopmental disorders such as autism spectrum disorder
* Intellectual Disability (IQ less than 70, per self-report)
* Currently impaired by any medical condition that would prevent study participation
* Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and/or impairments in concentration.
* Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC/PTSD youth)
* Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep.
* Possible pregnancy
* No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia.
* Current diagnosis of a sleep disorder (self-report).
* Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc.

Contacts and Locations

Study Contact

Sara Heyn, JD, PhD

CONTACT

303-296-2116

sheyn@wisc.edu

Principal Investigator

Stephanie Jones, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Stephanie Jones, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16

Study Completion Date2028-10

Study Record Updates

Study Start Date2024-07-16

Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

Post Traumatic Stress Disorder