Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary goal of this project is to develop a tailored screening, brief intervention and referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for delivery at point of care during a routine healthcare visit, through conducting a rigorous randomized control trial among adolescent patients with type 1 diabetes (TID) or rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of parents of these same adolescents, to explore links between parent beliefs and adolescent behavior around substance use.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Check Yourself v2.0

NCT02882919

Adolescent Behavior

COMPLETED NA

I-ACT With Check Yourself

NCT02764190

Adolescent Behavior

COMPLETED NA

Recovery Management Checkups for Primary Care Experiment

NCT03746756

Substance Use Disorders

COMPLETED NA

Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

NCT05834725

Pain, Chronic Pain Syndrome Psychological

ACTIVE_NOT_RECRUITING NA

Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico

NCT06208696

Long Covid19

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed project is a randomized control trial to assess the efficacy of an SBIRT model tailored to youth with chronic medical conditions. This trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. The first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. In the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief Intervention OR Treatment as Usual (TAU). In the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries.

At baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. The investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Those in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education on substance use. Content in the intervention will focus on health promotion and will deliver positive messages about health.

Group Type EXPERIMENTAL

Brief psycho-educational intervention

Intervention Type BEHAVIORAL

Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.

Control

Those in the control arm will receive treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief psycho-educational intervention

Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 14-17 year-old youth presenting for routine medical care in the Rheumatology clinic or Endocrinology clinic at Boston Children's Hospital (BCH)
* A diagnosis of type 1 diabetes for at least a year or a diagnosis of a Rheumatologic condition for at least a year.
* Able to read and understand English at a middle school level or greater
* Consent to participation in the study and consent to the 6 month and 12 month follow up assessments.

Exclusion Criteria

* Patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team
* Unable to speak/read English at a middle school reading level
* Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
* Do not consent to 6 month and 12 month re-assessment.
* Patients who are pregnant at baseline

Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No