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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803567
• Other study ID #: P00021649
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: November 26, 2019

Study information

• Verified date: July 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Conrad N. Hilton Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.	We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.	12 months post intervention
Secondary	Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.	We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.	12 months post intervention
Secondary	Perceived risk of harm of substance use	We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.	12 months post intervention
Secondary	Medication Adherence measured by self-report		12 months post intervention