NCT01572441

Brief Summary

The purpose of this study is to observe parent-adolescent interactions and to examine the parenting behaviors and adolescent emotional and physiological responses that are associated with youth's substance use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

January 8, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

5.9 years

First QC Date

April 3, 2012

Last Update Submit

August 6, 2019

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (5)

  • Substance Use

    Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results.

    Baseline

  • Substance Use

    Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results.

    6 month follow-up

  • Substance Use

    Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results.

    1 year follow-up

  • Substance Use

    Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results.

    2 year follow-up

  • Substance Use

    Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results.

    3 year follow-up

Study Arms (1)

12-14 year olds

No intervention administered. This is a longitudinal observational study including observation of behaviors and physiological responses.

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

12-14 year olds and their primary caregivers.

You may qualify if:

  • Adolescent between ages 12-14 years

You may not qualify if:

  • For adolescent, Intelligence Quotient (IQ) \< 70 on standardized test, for parent, evidence of inability to read or write.
  • Evidence of a psychotic disorder for parent or adolescent
  • Diagnosis of autism or pervasive developmental disorder for adolescent, as determined by parent report in the screening.
  • For adolescent, current need for acute treatment of a psychiatric disorder, as determined by parent report in the study screening.
  • For adolescent and parent, inadequate English proficiency to comprehend task instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Stress Center

New Haven, Connecticut, 06520, United States

Location

George Mason University

Fairfax, Virginia, 22030, United States

Location

Related Publications (2)

  • Chaplin TM, Sinha R, Simmons JA, Healy SM, Mayes LC, Hommer RE, Crowley MJ. Parent-adolescent conflict interactions and adolescent alcohol use. Addict Behav. 2012 May;37(5):605-12. doi: 10.1016/j.addbeh.2012.01.004. Epub 2012 Jan 13.

    PMID: 22341765BACKGROUND

  • Turpyn CC, Chaplin TM, Cook EC, Martelli AM. A person-centered approach to adolescent emotion regulation: Associations with psychopathology and parenting. J Exp Child Psychol. 2015 Aug;136:1-16. doi: 10.1016/j.jecp.2015.02.009. Epub 2015 Apr 4.

    PMID: 25846016RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Retain saliva sample.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Tara Chaplin, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 6, 2012

Study Start

January 8, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

We will make data from the proposed laboratory study available to other researchers, after de-identifying study data and after publishing the main manuscripts on the study.

Locations

US(2)