NCT00925340

Brief Summary

A two group randomized design will be used to test the primary hypothesis that the experimental intervention will reduce alcohol consumption and alcohol-related negative consequences significantly more than a comparison family-based psychoeducation condition in both an identified alcohol-using adolescent (12- 18 years old) and his/her teenage sibling (the sibling can be 3 years older or younger than teen with the sibling's age between 12-21 years old). The experimental condition consists of the Family Check-up, while the comparison condition is a less intense parenting psychoeducation program. Time points will include follow-ups at 3, 6, and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

5.8 years

First QC Date

June 19, 2009

Last Update Submit

July 28, 2014

Conditions

Alcohol Abuse

Keywords

AlcoholSubstance AbuseAdolescentFamily functioning

Outcome Measures

Primary Outcomes (3)

  • Teen and sibling alcohol use

    drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)

    3 months

  • Teen and sibling alcohol use

    drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion

    6 months

  • Teen and sibling alcohol use

    drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion

    12 months

Secondary Outcomes (3)

  • Teen and sibling marijuana use

    3 months

  • Teen and sibling marijuana use

    6 months

  • Teen and siblings marijuana use

    12 months

Study Arms (2)

1 - Family Check Up

EXPERIMENTAL

Brief family intervention that employs Motivational Interviewing.

Behavioral: Family Check Up

2 - Psychoeducation

ACTIVE COMPARATOR
Behavioral: Psychoeducation

Interventions

Family Check UpBEHAVIORAL

The Family Check-Up provides a thorough assessment of individual family strengths and weaknesses and utilizes principles of motivational interviewing to encourage families to change.

1 - Family Check Up
PsychoeducationBEHAVIORAL

Psychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs.

2 - Psychoeducation

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants will be 12 to 18 years old, inclusive, living at home with at least one parent or guardian.
  • Participants will have a teenage sibling within 3 years of age of the identified adolescent patient. Siblings can be either biological or unrelated siblings in blended families, as long as they live in the same home as the parents targeted in the intervention conditions. The adolescent must have experienced a recent (within 1 month) alcohol-related event (ED admission, school disciplinary action, grounding by parents, legal action). The adolescent must also screen in by reaching the clinical cutoff score on the Adolescent Drinking Index.

You may not qualify if:

  • Alcohol positive adolescents with substance dependence diagnosis requiring a higher level of care; 18 year olds living on their own.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Spirito A, Hernandez L, Marceau K, Cancilliere MK, Barnett NP, Graves HR, Rodriguez AM, Knopik VS. Effects of a brief, parent-focused intervention for substance using adolescents and their sibling. J Subst Abuse Treat. 2017 Jun;77:156-165. doi: 10.1016/j.jsat.2017.02.002. Epub 2017 Mar 2.

    PMID: 28259500DERIVED

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anthony Spirito, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)