RECRUITING

SilverCloud as a School-Based Intervention for Vulnerable Youth

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 study is to test the efficacy and feasibility of a clinician-guided, app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental health intervention for vulnerable youth. An open trial of SilverCloud will be conducted to determine preliminary efficacy in this sample and inform program refinements by collecting outcome self-report assessments and conducting interviews on feasibility and acceptability. After the program and its implementation strategy are refined, we will conduct an randomized controlled trial. Adolescents who seek or are referred for mental health services through one of the study sites and screen positive for significant mental health symptoms will be randomized to receive SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome self-reports. Feasibility and acceptability feedback will again be collected from participants, SBHC staff, and community members.

Official Title

Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth

Quick Facts

Study Start:2024-02-08
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06004414

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 22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrolled in a high school
  2. * Score of 10+ on GAD-7 or PHQ-9
  3. * Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.
  4. * Enrolled in 9th through 11th grades.
  5. * Score of 10+ on GAD-7 or PHQ-9
  6. * Enrolled in one of the study sites
  7. * Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.
  1. * Does not use a smartphone
  2. * Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
  3. * Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated.
  4. * Current (within 1 month of enrollment) mental health treatment at one of the study sites
  5. * Does not use a smartphone
  6. * Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
  7. * Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred for crisis intervention through the site at which they were referred and will not be eligible until their suicidal thoughts have abated.

Contacts and Locations

Study Contact

Anna Van Meter, PhD
CONTACT
646-754-5085
anna.vanmeter@nyulangone.org
Erum Nadeem, PhD
CONTACT
Erum.nadeem@rutgers.edu

Principal Investigator

Anna Van Meter, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Erum Nadeem, PhD
PRINCIPAL_INVESTIGATOR
Rutgers University

Study Locations (Sites)

Rutgers University
New Brunswick, New Jersey, 08901
United States
NYU Langone Health
Brooklyn, New York, 11220
United States
Northwell Health School Mental Health Partnership sites
Glen Oaks, New York, 11004
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Anna Van Meter, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Erum Nadeem, PhD, PRINCIPAL_INVESTIGATOR, Rutgers 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 Date2024-02-08
Study Completion Date2027-01

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • depression
  • anxiety
  • behavioral therapy

Additional Relevant MeSH Terms

  • Depression
  • Anxiety