Adolescent Substance UsePhase 1tCheckupNCT01170013
Substance Use Prevention in Teen Psychiatric Patients
A Phase 1 study testing Family Check-up and Parent psychoeducation in people with Adolescent Substance Use, run by Brown University at 1 site in United States.
Trial summary
The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Adolescent Substance Use
- What is being tested?
- Family Check-up and Parent psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2011
- Phase
- Phase 1
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the target child is between the ages of 12-14 years old at the start of the project and living at home with at least one parent/guardian
- the target child must be receiving services at a mental health clinic and must screen in with a t- score of 70 or above on one of the DSM-oriented scales (ADHD, ODD, CD, anxiety problems, and affective problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off)
- the child must not report prior AOD use, and
- parental consent and child assent are obtained.
Who cannot join
- the target child is actively psychotic, and
- the family is not able to speak and understand English or Spanish well enough to complete study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substance Abuse Prevention for Preadolescents With Psychiatric Disorders
The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.
Read the detailed description
The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.
- Conditions
- Adolescent Substance Use
- Being tested
- Family Check-up, Parent psychoeducation
- Keywords
- substance use, adolescents, initiation
- 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.
Family Check-upBehavioural
Also called Parent Motivational Interviewing
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Parent psychoeducationBehavioural
Also called Family psychoeducation
Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use
| Study group | Role | What they receive |
|---|---|---|
| Family Check-up | Experimental | Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use Receives: Behavioral: Family Check-up |
| Psychoeducation | Active comparator | Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use Receives: Behavioral: Parent psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental monitoring/communication
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
Measured: 3 months
Parental monitoring/communication
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
Measured: 6 months
Secondary outcomes (4)
marijuana use
frequency and quantity of marijuana use in the prior 30 days
Measured: 3 months
marijuana use
frequency and quantity of marijuana use in the prior 30 days
Measured: 6 months
alcohol use
frequency and quantity of alcohol use in the prior 30 days
Measured: 3 months
alcohol use
frequency and quantity of alcohol use in the prior 30 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionDec 2011
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 Brown UniversityThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170013
- Sponsor's protocol ID
- 1R21DA024207
- Acronym
- tCheckup
- Status last verified
- Jul 2012
- First submitted
- 2 Jun 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Abuse Prevention for Preadolescents With Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT01170013
- Acronym / sponsor ID
- tCheckup / 1R21DA024207
- Conditions
- Adolescent Substance Use
- Keywords
- substance use, adolescents, initiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jul 2010 (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 earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.
Detailed description
The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Check-up | Experimental | Behavioral: Family Check-upTwo session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use |
| Psychoeducation | Active comparator | Behavioral: Parent psychoeducationTwo sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- the target child is between the ages of 12-14 years old at the start of the project and living at home with at least one parent/guardian
- the target child must be receiving services at a mental health clinic and must screen in with a t- score of 70 or above on one of the DSM-oriented scales (ADHD, ODD, CD, anxiety problems, and affective problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off)
- the child must not report prior AOD use, and
- parental consent and child assent are obtained.
Key exclusion criteria (2 listed)
- the target child is actively psychotic, and
- the family is not able to speak and understand English or Spanish well enough to complete study procedures.
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 |
|---|---|---|
| Family Check-upAlso: Parent Motivational InterviewingTwo session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use | Behavioural | Family Check-up |
| Parent psychoeducationAlso: Family psychoeducationTwo sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use | Behavioural | Psychoeducation |
Primary outcome
Parental monitoring/communication
Time frame: 3 months
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
Parental monitoring/communication
Time frame: 6 months
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
4 secondary outcomes
marijuana use
Time frame: 3 months
marijuana use
Time frame: 6 months
alcohol use
Time frame: 3 months
alcohol use
Time frame: 6 months
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 31 Jul 2012.
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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.
Anthony Spirito, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Family Check-up and Parent psychoeducation in people with Adolescent Substance Use, run by Brown University 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 4 inclusion and 2 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 31 Jul 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parental monitoring/communication (time frame: 3 months). The study lists 2 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 31 Jul 2012.