RECRUITING

A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).

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 randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up. The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.

Official Title

Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems (R33)

Quick Facts

Study Start:2024-04-01
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06526052

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:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Ages 12, 13, 14, 15, 16, 17
  2. * Parental Consent
  3. * Participant Assent
  4. * Live in Illinois, California, or Tennessee
  1. * current diagnosis of an anxiety or depressive disorder with significant clinical impairment
  2. * current alcohol or substance use disorder
  3. * current serious suicidal ideation or behavior
  4. * lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
  5. * reading level below 4th grade
  6. * not English speaking at a level that would allow them to participate in the intervention and assessments

Contacts and Locations

Study Contact

Judith A Garber, PhD
CONTACT
6153305605
jgarber.vanderbilt@gmail.com
Steven D Hollon, PhD
CONTACT
6153305604
steven.d.hollon@vanderbilt.edu

Principal Investigator

Megan M Saylor, PhD
STUDY_CHAIR
Vanderbilt University

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States
Northwestern University
Evanston, Illinois, 60208
United States
Vanderbilt University
Nashville, Tennessee, 37203-5721
United States

Collaborators and Investigators

Sponsor: Vanderbilt University

  • Megan M Saylor, PhD, STUDY_CHAIR, Vanderbilt University

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 Date2024-04-01
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Adolescents
  • Mindfulness
  • Internalizing

Additional Relevant MeSH Terms

  • Prevention
  • Control