Substance AbusePAITNCT01572441
Parent-Adolescent Interactions and Adolescent Development
An observational study of Substance Abuse, run by George Mason University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- How many people
- 245 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2013to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 12-14 year olds and their primary caregivers.
Who may be able to join
- Adolescent between ages 12-14 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
George Mason University
Fairfax, Virginia, 22030
Yale Stress Center
New Haven, Connecticut, 06520
About this study
Official title: Responses During Parent-child Interactions and Alcohol Use Behavior in Adolescents.
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.
Read the detailed description
The study examines parenting behaviors and adolescent emotional responses during parent-adolescent interactions and whether these predict youth's current and future substance use over a 3 year follow-up.
- Conditions
- Substance Abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 12-14 year olds | No intervention administered. This is a longitudinal observational study including observation of behaviors and physiological responses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study start8 Jan 2013
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tara M. Chaplin, Ph.D., George Mason University
- Investigators
- Tara Chaplin, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572441
- Sponsor's protocol ID
- 0909005677
- Other IDs
- R01DA033431
- Acronym
- PAIT
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2012
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 22341765Turpyn 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.
PubMed 25846016
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responses During Parent-child Interactions and Alcohol Use Behavior in Adolescents.
- ClinicalTrials.gov ID
- NCT01572441
- Acronym / sponsor ID
- PAIT / 0909005677
- Conditions
- Substance Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study examines parenting behaviors and adolescent emotional responses during parent-adolescent interactions and whether these predict youth's current and future substance use over a 3 year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12-14 year olds | – | –No intervention administered. This is a longitudinal observational study including observation of behaviors and physiological responses. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 12-14 year olds and their primary caregivers.
Key inclusion criteria (1 listed)
- Adolescent between ages 12-14 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Substance Use
Time frame: Baseline
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.
Substance Use
Time frame: 6 month follow-up
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.
Substance Use
Time frame: 1 year follow-up
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.
Substance Use
Time frame: 2 year follow-up
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.
Substance Use
Time frame: 3 year follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 22341765Chaplin 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.
- Results publication: PubMed 25846016Turpyn 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara Chaplin, Ph.D. principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse, run by George Mason University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance Use (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.