Substance UseNCT01170026
Individual and Family Motivational Interviews for Substance Using Truant Teens
A study testing Family Check-up/ Individual MI and Individual and family psychoeducation in people with Substance Use, run by Brown University at 1 site in United States.
Trial summary
This application will provide a test of one potential model for adding substance use assessment and brief intervention into a truancy court program. The primary goal of this study is to determine whether a motivational intervention will reduce substance use among adolescents referred to truancy court for school… Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Family Check-up/ Individual MI and Individual and family psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between the ages of 13-16 at the start of the project and living at home with at least one parent/guardian,
- t- score of 70 or above on one of the diagnostic-oriented scales (internalizing or externalizing problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off),
- the child must report 6 or more incidences of substance use in the last 90 days,
- parental consent and child assent are obtained.
Who cannot join
- adolescent meets diagnostic criteria for substance dependence suggesting need for more intensive services,
- 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
This application will provide a test of one potential model for adding substance use assessment and brief intervention into a truancy court program. The primary goal of this study is to determine whether a motivational intervention will reduce substance use among adolescents referred to truancy court for school attendance problems. In this treatment development application, an open trial with 20 families referred by truancy court will first be conducted. This trial will be used to adapt an existing motivational intervention to include material relevant to school attendance and performance. Then 100 families participating in the Rhode Island Truancy Court Program with adolescents between the ages of 13-16 years who report using substances will be randomly assigned to receive the experimental intervention plus standard truancy court procedures or psychoeducation plus standard truancy court procedures. The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion \& Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance. Follow-up interviews will be conducted at 3 and 6 months.
- Conditions
- Substance Use
- Being tested
- Family Check-up/ Individual MI, Individual and family psychoeducation
- Keywords
- substance use, adolescents, intervention, truancy
- 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-up/ Individual MIBehavioural
Also called (Family Check-up)
The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion \& Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance.
Individual and family psychoeducationBehavioural
Also called (Psychoed)
Families in PE will return for the same number of visits as the IMI and FCU sessions of the IMI/FCU condition. An interventionist will review a set of educational materials with the parents regarding teen SU use, truancy and risk behaviors and parenting a teenager. A similar set of materials will be reviewed with the adolescent
| Study group | Role | What they receive |
|---|---|---|
| Family Check-up/Individual MI | Experimental | Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use plus 2 session Individual Motivational Intervention for the adolescent Receives: Behavioral: Family Check-up/ Individual MI |
| Psychoeducation | Active comparator | Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use Receives: Behavioral: Individual and family psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Use Days in Past 90 Days
Number of Days in which a Participant Responded "Yes" to Marijuana use in the Past 90 Days" range = 0 to 90; higher scores indicate more marijuana use
Measured: 3 Month Follow-Up and 6 month follow-up
Alcohol Use Days in Past 90 Days
If a Participant Responded "Yes" to Alcohol use in the Past 90 Days" ; yes /no
Measured: 3 and 6 Month Follow-Up
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 2010
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 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 Medicl School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170026
- Sponsor's protocol ID
- 1 R34 DA0029871
- Status last verified
- Nov 2024
- First submitted
- 22 Jul 2010
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Family Motivational Interviews for Substance Using Truant Teens
- ClinicalTrials.gov ID
- NCT01170026
- Acronym / sponsor ID
- 1 R34 DA0029871
- Conditions
- Substance Use
- Keywords
- substance use, adolescents, intervention, truancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This application will provide a test of one potential model for adding substance use assessment and brief intervention into a truancy court program. The primary goal of this study is to determine whether a motivational intervention will reduce substance use among adolescents referred to truancy court for school attendance problems. In this treatment development application, an open trial with 20 families referred by truancy court will first be conducted. This trial will be used to adapt an existing motivational intervention to include material relevant to school attendance and performance. Then 100 families participating in the Rhode Island Truancy Court Program with adolescents between the ages of 13-16 years who report using substances will be randomly assigned to receive the experimental intervention plus standard truancy court procedures or psychoeducation plus standard truancy court procedures. The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion \& Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance. Follow-up interviews will be conducted at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Check-up/Individual MI | Experimental | Behavioral: Family Check-up/ Individual MITwo session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use plus 2 session Individual Motivational Intervention for the adolescent |
| Psychoeducation | Active comparator | Behavioral: Individual and family psychoeducationTwo sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- between the ages of 13-16 at the start of the project and living at home with at least one parent/guardian,
- t- score of 70 or above on one of the diagnostic-oriented scales (internalizing or externalizing problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off),
- the child must report 6 or more incidences of substance use in the last 90 days,
- parental consent and child assent are obtained.
Key exclusion criteria (2 listed)
- adolescent meets diagnostic criteria for substance dependence suggesting need for more intensive services,
- 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-up/ Individual MIAlso: (Family Check-up)The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion \& Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance. | Behavioural | Family Check-up/Individual MI |
| Individual and family psychoeducationAlso: (Psychoed)Families in PE will return for the same number of visits as the IMI and FCU sessions of the IMI/FCU condition. An interventionist will review a set of educational materials with the parents regarding teen SU use, truancy and risk behaviors and parenting a teenager. A similar set of materials will be reviewed with the adolescent | Behavioural | Psychoeducation |
Primary outcome
Marijuana Use Days in Past 90 Days
Time frame: 3 Month Follow-Up and 6 month follow-up
Number of Days in which a Participant Responded "Yes" to Marijuana use in the Past 90 Days" range = 0 to 90; higher scores indicate more marijuana use
Alcohol Use Days in Past 90 Days
Time frame: 3 and 6 Month Follow-Up
If a Participant Responded "Yes" to Alcohol use in the Past 90 Days" ; yes /no
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Medicl School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-up/ Individual MI and Individual and family psychoeducation in people with 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 15 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Marijuana Use Days in Past 90 Days (time frame: 3 Month Follow-Up and 6 month follow-up). 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 15 Jan 2025.