RECRUITING

Real-time Examination of Skills and Coping Use in Teen's Everyday Lives

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 compare two core intervention skills among adolescents with a history of engaging in at least 3 lifetime incidents of self-inflicted injury (SII), at least one of which was a suicide attempt of at least moderate lethality and moderate intent to die. The main questions it aims to answer are: Whether and when youth use skills in daily life, how quickly skill use declines after teaching, and whether exposure to life stress influences skill learning and retention. The Investigators also want to know whether brain-related, family-related, and physiology-related factors influence skills practice and any associated changes in self-harm/suicide risk and emotion dysregulation. Participants will complete surveys 5 times a day on their phones at baseline, and following each skill learning session. All participants will learn and practice the two skills with a parent while discussing topics they often argue about. During these discussions, participants will be hooked up to psychophysiological equipment to measure their cardiovascular functioning and their palm sweat. Participants' discussions will be coded for skill use and also for indices of family functioning. Approximately half of the participants will undergo two sets of fMRI scans to assess potential neural underpinnings of skill use.

Official Title

Examining Mechanisms of Change in Adolescent Self-Inflicted Injury

Quick Facts

Study Start:2024-07-29
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06720753

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:13 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 3+ incidents of self-inflicted injury (SII). At least one SII episode must score a minimum of "3" on lethality (moderate; e.g., overdose on 11-50 pills; deep cuts anywhere but neck) and "4" on intent (somewhat serious \[about dying\]) - even if aborted or interrupted. Adolescents with 3+ SIIs may also enroll if they have been hospitalized for suicide preparatory behavior.
  2. * English language proficiency
  3. * Access to a smart phone
  4. * Parent/caregiver/legal guardian to participate with the adolescent
  1. * Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis.
  2. * Those taking medications with well-documented effects on psychophysiological responding.

Contacts and Locations

Study Contact

Erin Kaufman, Ph.D.
CONTACT
8017819433
erin.kaufman@utah.edu

Principal Investigator

Erin Kaufman, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Erin Kaufman, Ph.D., PRINCIPAL_INVESTIGATOR, University of Utah

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 Date2024-07-29
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2024-07-29
Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

  • Self Injurious Behavior
  • Dialectical Behavior Therapy
  • Therapy mechanisms
  • Suicide
  • Adolescents
  • Families
  • fMRI
  • Psychophysiological measures

Additional Relevant MeSH Terms

  • Self Injurious Behavior
  • Suicide