RECRUITING

Brain, Emotions, and Mind-Wandering

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

Mood lability is an important transdiagnostic problem that is associated with poor psychosocial function and suicidal thoughts, and is a predictor of mood disorder onset, especially in youth at familial risk. Thus, particularly in youth with a family history of mood disorder, an intervention to target mood lability during a key period of development could improve outcomes. This study will allow us to test neurobehavioral mechanisms of a mindfulness-based intervention to target mood lability in early adolescents at high risk for developing mood disorders. Through this randomized controlled trial, the investigators will better understand how and for whom mindfulness interventions work, which will lead to more targeted interventions to improve emotion regulation during this key developmental period.

Official Title

Neurobehavioral Targets of Mindfulness in Youth at Risk for Mood Disorders

Quick Facts

Study Start:2022-09-23
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05345392

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:11 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Males and females between the ages of 11-14 years
  2. * Parent or full biological sibling with major depressive disorder and/or bipolar I/II disorder
  3. * Elevated mood lability, which is defined as \>10 on the Children's Affective Lability Scale (averaging the child and parent score).
  1. * IQ\<70 or significant learning disability (which will make it difficult to participate in study procedures)
  2. * Current or previous diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or autism spectrum disorder
  3. * Current diagnosis of major depressive disorder
  4. * Contraindications to scanning, including metal in the body (e.g. has braces or planning to get braces within the next 8 months)
  5. * Suicidal or homicidal ideation within the past month
  6. * Changed medications or medication doses (including psychotropic medications and/or hormonal contraceptives), or have started a new therapy, within the past two months.

Contacts and Locations

Study Contact

Danella Hafeman, MD, PhD
CONTACT
412-246-5820
hafemand@upmc.edu
Jamie Feldman, BA
CONTACT
412-527-6231
feldmanj3@upmc.edu

Principal Investigator

Danella Hafeman, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Danella Hafeman, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2022-09-23
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-09-23
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • mindfulness-based intervention
  • early intervention
  • prevention
  • adolescent

Additional Relevant MeSH Terms

  • Mood Disorders