Adolescent Substance UseNCT02622451
Differential Sensitivity Markers in Youth Drug Abuse Prevention
A study testing Teen Intervene and Everyday Parenting in people with Adolescent Substance Use, run by University of Minnesota at 1 site in United States.
Trial summary
This pilot study conducts feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework that seeks to preempt the progression from early drug use to more chronic abuse and dependency. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Substance Use
- What is being tested?
- Teen Intervene and Everyday Parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 8 Mar 2020
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth ages 12-17
- Substance Use referral to community partner agency
- Adolescent report of weekly-monthly use of one or more substances within the prior 6 months
Who cannot join
- Current DSM-5 diagnosis of a severe substance use disorder (i.e. substance dependence)
- Adolescent report of daily use of substance within prior 6 months
- Current or past history of psychosis (including suicidal ideation)
- Pervasive developmental disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Personalized Prevention Research in Children's Mental Health
Minneapolis, Minnesota, 55415
About this study
This pilot study conducts feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework that seeks to preempt the progression from early drug use to more chronic abuse and dependency. The study will explore moderators representing two frameworks, risk severity and differential sensitivity. Moderators will be explored in their ability to influence the differential efficacy of two adolescent drug abuse interventions.
Read the detailed description
This R34 pilot study proposes to conduct feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework for early stage adolescent drug users. The study will explore putative moderators representing two theoretically distinct frameworks and determine whether they are suitable candidates for a subsequent R01 study. One moderation framework is based on risk severity (RS) as reflected by individual differences in delay discounting (DD), a form of impulsive decision making that is positively associated with escalation to more serious levels of abuse and addiction. A second more exploratory framework is based on differential sensitivity (DS) theory. The DS framework stipulates that individuals, due to specific sensitivity factors, vary in their responsiveness to environmental influence such as the influence provided by an intervention. The study will explore DS markers associated with the reward motivational system, including dopaminergic genes, the post-auricular physiological reflex and a high sensory-processing sensitivity trait. An agency-university partnership will collaborate in providing services to 120 adolescents (ages 12-17) who were referred to a community counseling center because of a recent alcohol and/or marijuana incident. Recruitment will select mild/moderate drug users. Participants will be randomized to one of two evidence-based drug abuse interventions. The two interventions offer the same delivery dosage but differ in terms of their mechanism of therapeutic change (i.e., degree of environmental influence). The Teen Intervene program (TI; Winters \& Leitten, 2007) is a youth-focused intervention that uses motivational interviewing, goal setting, and skills training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors. The Everyday Parenting program (EP; Dishion et al., 2003; 2010) is a family focused-intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives to drug use. The aims of this R34 are to (1) assess feasibility of recruiting, assessing, and following-up enrolled youth in an intervention trial, (2) assess the ability of staff to implement TI and EP with fidelity, and (3) obtain promising data on moderator and outcome variables that will help answer the question of "what intervention works best for which youth" in a subsequent R01 study.
- Conditions
- Adolescent Substance Use
- Being tested
- Teen Intervene, Everyday Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen InterveneBehavioural
Teen Intervene (TI) is an early intervention program for 12-19 year olds who display early stages of alcohol or drug use. TI uses motivational interviewing, goal setting, and skill training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors.
Everyday ParentingBehavioural
Everyday Parenting is a family-focused intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives.
| Study group | Role | What they receive |
|---|---|---|
| Youth Behavioral Intervention | Other | Teen Intervene Receives: Behavioral: Teen Intervene |
| Parent Education | Other | Everyday Parenting Receives: Behavioral: Everyday Parenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Discounting Task
Youth Computer Task
Measured: 4 months post-intervention
Iowa Gambling Task
Youth Computer Task
Measured: 4 months post-intervention
Urinalysis
Adolescents will provide urine samples for urinalysis to test for recent drug usage.
Measured: 4 months post-intervention
Peer Substance Use Test
Youth Report
Measured: 4 months post-intervention
Peer Delinquency Scale
Youth Report
Measured: 4 months post-intervention
Project Towards No Drug Abuse Survey
Youth Report
Measured: 4 months post-intervention
Alcohol Expectancy Questionnaire
Youth Report
Measured: 4 months post-intervention
Single-item self-efficacy Scale
Youth Report
Measured: 4 months post-intervention
Client Satisfaction Questionnaire
Parent \& Youth Report
Measured: 4 months post-intervention
Highly Sensitive Person Scale
Parent \& Youth Report
Measured: 4 months post-intervention
Parental Monitoring Instrument
Parent \& Youth Report
Measured: 4 months post-intervention
Parenting Relationship Questionnaire (PRQ)
Parent Report
Measured: 4 months post-intervention
Family Problem Solving Communication Index
Parent Report
Measured: 4 months post-intervention
Parental Locus of Control Questionnaire
Parent Report
Measured: 4 months post-intervention
Family Assessment Measure - III
Parent Report on family functioning .
Measured: 4 months post-intervention
Conflict Behavior Questionnaire
Parent Report
Measured: 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start1 Dec 2015
- Primary completion8 Mar 2020
- Study completion8 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Substance UseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Natalis Counseling Center
- Responsible party
- Sponsor
- Investigators
- Gerald August, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622451
- Sponsor's protocol ID
- 1504S69041
- Other IDs
- R34DA037888
- Status last verified
- Sep 2020
- First submitted
- 2 Dec 2015
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Sensitivity Markers in Youth Drug Abuse Prevention
- ClinicalTrials.gov ID
- NCT02622451
- Acronym / sponsor ID
- 1504S69041
- Conditions
- Adolescent Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Natalis Counseling Center
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 8 Mar 2020 (actual)
- Study completion
- 8 Mar 2020 (actual)
- First posted
- 4 Dec 2015 (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.
This pilot study conducts feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework that seeks to preempt the progression from early drug use to more chronic abuse and dependency. The study will explore moderators representing two frameworks, risk severity and differential sensitivity. Moderators will be explored in their ability to influence the differential efficacy of two adolescent drug abuse interventions.
Detailed description
This R34 pilot study proposes to conduct feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework for early stage adolescent drug users. The study will explore putative moderators representing two theoretically distinct frameworks and determine whether they are suitable candidates for a subsequent R01 study. One moderation framework is based on risk severity (RS) as reflected by individual differences in delay discounting (DD), a form of impulsive decision making that is positively associated with escalation to more serious levels of abuse and addiction. A second more exploratory framework is based on differential sensitivity (DS) theory. The DS framework stipulates that individuals, due to specific sensitivity factors, vary in their responsiveness to environmental influence such as the influence provided by an intervention. The study will explore DS markers associated with the reward motivational system, including dopaminergic genes, the post-auricular physiological reflex and a high sensory-processing sensitivity trait. An agency-university partnership will collaborate in providing services to 120 adolescents (ages 12-17) who were referred to a community counseling center because of a recent alcohol and/or marijuana incident. Recruitment will select mild/moderate drug users. Participants will be randomized to one of two evidence-based drug abuse interventions. The two interventions offer the same delivery dosage but differ in terms of their mechanism of therapeutic change (i.e., degree of environmental influence). The Teen Intervene program (TI; Winters \& Leitten, 2007) is a youth-focused intervention that uses motivational interviewing, goal setting, and skills training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors. The Everyday Parenting program (EP; Dishion et al., 2003; 2010) is a family focused-intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives to drug use. The aims of this R34 are to (1) assess feasibility of recruiting, assessing, and following-up enrolled youth in an intervention trial, (2) assess the ability of staff to implement TI and EP with fidelity, and (3) obtain promising data on moderator and outcome variables that will help answer the question of "what intervention works best for which youth" in a subsequent R01 study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youth Behavioral Intervention | Other | Behavioral: Teen InterveneTeen Intervene |
| Parent Education | Other | Behavioral: Everyday ParentingEveryday Parenting |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth ages 12-17
- Substance Use referral to community partner agency
- Adolescent report of weekly-monthly use of one or more substances within the prior 6 months
Key exclusion criteria (4 listed)
- Current DSM-5 diagnosis of a severe substance use disorder (i.e. substance dependence)
- Adolescent report of daily use of substance within prior 6 months
- Current or past history of psychosis (including suicidal ideation)
- Pervasive developmental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teen InterveneTeen Intervene (TI) is an early intervention program for 12-19 year olds who display early stages of alcohol or drug use. TI uses motivational interviewing, goal setting, and skill training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors. | Behavioural | Youth Behavioral Intervention |
| Everyday ParentingEveryday Parenting is a family-focused intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives. | Behavioural | Parent Education |
Primary outcome
Delayed Discounting Task
Time frame: 4 months post-intervention
Youth Computer Task
Iowa Gambling Task
Time frame: 4 months post-intervention
Youth Computer Task
Urinalysis
Time frame: 4 months post-intervention
Adolescents will provide urine samples for urinalysis to test for recent drug usage.
Peer Substance Use Test
Time frame: 4 months post-intervention
Youth Report
Peer Delinquency Scale
Time frame: 4 months post-intervention
Youth Report
Project Towards No Drug Abuse Survey
Time frame: 4 months post-intervention
Youth Report
Alcohol Expectancy Questionnaire
Time frame: 4 months post-intervention
Youth Report
Single-item self-efficacy Scale
Time frame: 4 months post-intervention
Youth Report
Client Satisfaction Questionnaire
Time frame: 4 months post-intervention
Parent \& Youth Report
Highly Sensitive Person Scale
Time frame: 4 months post-intervention
Parent \& Youth Report
Parental Monitoring Instrument
Time frame: 4 months post-intervention
Parent \& Youth Report
Parenting Relationship Questionnaire (PRQ)
Time frame: 4 months post-intervention
Parent Report
Family Problem Solving Communication Index
Time frame: 4 months post-intervention
Parent Report
Parental Locus of Control Questionnaire
Time frame: 4 months post-intervention
Parent Report
Family Assessment Measure - III
Time frame: 4 months post-intervention
Parent Report on family functioning .
Conflict Behavior Questionnaire
Time frame: 4 months post-intervention
Parent Report
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 21 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Gerald August, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Intervene and Everyday Parenting in people with Adolescent Substance Use, run by University of Minnesota at 1 site 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 3 inclusion and 4 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Delayed Discounting Task (time frame: 4 months post-intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2020.