RECRUITING

Cannabis, Linked Emotions, and Adolescent Risk Study

Conditions

Cannabis Use Depression Suicidal Ideation Adolescent Behavior

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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 study is to disentangle relationships between acute cannabis use and withdrawal on proximal depression and suicide risk and recovery in adolescents ages 12-18 years by incorporating time-varying patterns of substance use, mood, and SI. This project aims to guide the development of scalable, individualized, accessible, and affordable interventions aimed to reduce depression and suicide risk among adolescents.

Official Title

Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation with Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment

Quick Facts

Study Start:2024-12

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06576076

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 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Ages 12-18; * Current daily or near daily cannabis use (i.e., use ≥ 4 days per week on average; Timeline Followback); * Score ≥ 5 on PHQ-9 (telephone screener) or current depressive episode (Mini International Neuropsychiatric Interview Kid 7.0.2); * Current or recent (past month) SI (passive or active), plan, or attempt (Self-Injurious Thoughts and Behaviors Interview) (Nock et al., 2007); * Access to an internet-capable smartphone (iOS or Android); * Provision of at least 1 collateral contact for risk monitoring; * Provision of informed assent (or consent if 18 years or older) and parent/guardian consent if \<age 18; * Greater than 60% response rate to EMA prompts during the first EMA phase; * No immediate plan to discontinue cannabis use in the next 3 months; * Positive toxicology result for cannabis on baseline urinalysis.	* Any factor that impairs ability to comprehend and effectively participate, including acute intoxication at time of consent; * Cannabis use \>4 times/day on average (to maximize likelihood of capturing mood and SI during non-use times); * Inability to speak/write English fluently; * Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease; * Current epilepsy diagnosis; * Individuals who are under the legal protection of the government or state (wards of the state); * Response of "No" to the knowledge check question regarding EMA suicidality response time; * Inability to wear Fitbit device.

Inclusion Criteria

Exclusion Criteria

* Ages 12-18;
* Current daily or near daily cannabis use (i.e., use ≥ 4 days per week on average; Timeline Followback);
* Score ≥ 5 on PHQ-9 (telephone screener) or current depressive episode (Mini International Neuropsychiatric Interview Kid 7.0.2);
* Current or recent (past month) SI (passive or active), plan, or attempt (Self-Injurious Thoughts and Behaviors Interview) (Nock et al., 2007);
* Access to an internet-capable smartphone (iOS or Android);
* Provision of at least 1 collateral contact for risk monitoring;
* Provision of informed assent (or consent if 18 years or older) and parent/guardian consent if \<age 18;
* Greater than 60% response rate to EMA prompts during the first EMA phase;
* No immediate plan to discontinue cannabis use in the next 3 months;
* Positive toxicology result for cannabis on baseline urinalysis.

* Any factor that impairs ability to comprehend and effectively participate, including acute intoxication at time of consent;
* Cannabis use \>4 times/day on average (to maximize likelihood of capturing mood and SI during non-use times);
* Inability to speak/write English fluently;
* Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
* Current epilepsy diagnosis;
* Individuals who are under the legal protection of the government or state (wards of the state);
* Response of "No" to the knowledge check question regarding EMA suicidality response time;
* Inability to wear Fitbit device.

Contacts and Locations

Study Contact

Randi M Schuster, PhD

CONTACT

617-643-6673

rschuster@mgh.harvard.edu

Julia Jashinski, MSW

CONTACT

617-643-1984

jjashinski@mgh.harvard.edu

Principal Investigator

Randi M Schuster, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hopsital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Randi M Schuster, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2024-12

Study Completion Date2028-12

Study Record Updates

Study Start Date2024-12

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Cannabis Use
Depression
Suicidal Ideation
Adolescent Behavior