NCT02408952

Brief Summary

This study evaluates the implementation and effectiveness of two modalities of Screening, Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other drug (AOD) use in a large pediatrics clinic.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9,084

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
10.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

March 20, 2015

Last Update Submit

July 14, 2023

Conditions

Substance Related Disorders

Outcome Measures

Primary Outcomes (5)

  • Screening rate

    The proportion of patients who are screened with the Teen Well Check Questionnaire AOD use or Mood symptom questions, among all patients with Teen well-child visits.

    Initial screening rate - at index well-visit

  • Problem Identification rate

    The proportion of patients screened who answer "yes" to AOD use or Mood symptoms in past 12 months and "yes" to at least one non-car CRAFFT question. (Being in a car with someone using AOD may not be related to child's problem, but to having a parent/other adult who has driven while drinking/using).

    Initital problem identification rate - at index well-visit, following screening

  • Assessment rate

    Proportion of patients screening positive for alcohol or other drug, or mental health risk, who are assessed further using the CRAFFT tool.

    Within 2 weeks following index well-visit date

  • Brief Intervention rate

    The proportion of patients who receive an intervention within 14 days, among those who are identified with AOD risk (based on CRAFFT score). Documented in EHR by clinicians, using an ICD-9 Administrative V-code for substance use counseling or behavioral counseling.

    Within 14 days of assessment at index well visit

  • Referral to specialty treatment rate

    The proportion of patients who receive referrals to specialty behavioral health treatment, among those identified through the CRAFFT as needing such treatment. Documented in the EHR.

    Within 6 months of index well-visit

Secondary Outcomes (3)

  • Specialty Behavioral Health Treatment Initiation

    Within 2 years post-intervention

  • Alcohol and other drug use

    Use in past 6 months, at 1 and 2 years post-intervention

  • Substance Use-related outcomes

    in past 6 months, at 1 and 2 years post-intervention

Study Arms (3)

Primary Care Physician

EXPERIMENTAL

If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered is by the primary care physician

Behavioral: Primary Care Physician

Behavioral Medicine Specialist

EXPERIMENTAL

If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered by the behavioral medicine specialist

Behavioral: Behavioral Medicine Specialist

Usual Care

NO INTERVENTION

Care is administered as usual

Interventions

Primary Care PhysicianBEHAVIORAL

The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician

Primary Care Physician
Behavioral Medicine SpecialistBEHAVIORAL

The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.

Behavioral Medicine Specialist

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All adolescent primary care providers at the pediatric primary care clinic will be included.
  • All adolescent patient electronic records, ages 12-18, at the pediatric primary care will be examined.

You may not qualify if:

  • Any adolescent primary care providers not practicing at the pediatric primary care clinic research site will be excluded.
  • Adolescents electronic records who are not part of the research site pediatric clinic will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stacy A Sterling

Oakland, California, 94612, United States

Location

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  • Parthasarathy S, Kline-Simon AH, Jones A, Hartman L, Saba K, Weisner C, Sterling S. Three-Year Outcomes After Brief Treatment of Substance Use and Mood Symptoms. Pediatrics. 2021 Jan;147(1):e2020009191. doi: 10.1542/peds.2020-009191.

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  • Sterling S, Kline-Simon AH, Weisner C, Jones A, Satre DD. Pediatrician and Behavioral Clinician-Delivered Screening, Brief Intervention and Referral to Treatment: Substance Use and Depression Outcomes. J Adolesc Health. 2018 Apr;62(4):390-396. doi: 10.1016/j.jadohealth.2017.10.016. Epub 2018 Feb 1.

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  • Sterling S, Kline-Simon AH, Jones A, Satre DD, Parthasarathy S, Weisner C. Specialty addiction and psychiatry treatment initiation and engagement: Results from an SBIRT randomized trial in pediatrics. J Subst Abuse Treat. 2017 Nov;82:48-54. doi: 10.1016/j.jsat.2017.09.005. Epub 2017 Sep 10.

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  • Sterling S, Kline-Simon AH, Satre DD, Jones A, Mertens J, Wong A, Weisner C. Implementation of Screening, Brief Intervention, and Referral to Treatment for Adolescents in Pediatric Primary Care: A Cluster Randomized Trial. JAMA Pediatr. 2015 Nov;169(11):e153145. doi: 10.1001/jamapediatrics.2015.3145. Epub 2015 Nov 2.

    PMID: 26523821DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Physicians, Primary Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 6, 2015

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 31, 2025

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

US(1)