Adolescent Problem BehaviorGOALSNCT03655574
Substance Use Interventions for Truant Adolescents
A study testing Motivational + Family Check-up (MET+FCU) and Psychoeducation in people with Adolescent Problem Behavior and Truancy; Unsocialized, run by Brown University at 2 sites in United States.
Trial summary
This study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. It is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Problem Behavior, Truancy; Unsocialized, Marijuana Abuse
- What is being tested?
- Motivational + Family Check-up (MET+FCU) and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2019to 30 Apr 2024
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- the target child is in 6th-10th grade at the start of the project and living at home with at least one parent/guardian,
- the teen must report 6 or more incidences of marijuana use in the last 90 days (an approximation of biweekly use)
- by law, the teen must have at least 20 unexcused absences in an academic year to be in truancy court, and (4) parental consent and teen assent are obtained.
Who cannot join
- the family is not able to speak and understand English or Spanish well enough to complete study procedures
- developmental delay, as determined by school placements outside the regular classroom, that would affect comprehension of the intervention.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Family Court
Providence, Rhode Island, 02903
Brown Univerity
Providence, Rhode Island, 02912
About this study
Official title: Brief Individual and Parent Interventions for Substance Use in Truant Adolescents
This study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. It is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention.
Read the detailed description
Adolescents who use marijuana and are truant from school are a high-risk population with increased likelihood of substance use disorders, criminal justice involvement, and long-term impairments in vocational, family, and peer domains.
This study will test a theory-driven intervention for early adolescent marijuana using, truant youth identified through Rhode Island Truancy and Family Courts. Adolescents will be randomly assigned to one of the 2 conditions: a motivational interview versus psychoeducation.
- Conditions
- Adolescent Problem Behavior, Truancy; Unsocialized, Marijuana Abuse, Truancy; Socialized, Substance Abuse, Alcohol Abuse
- Being tested
- Motivational + Family Check-up (MET+FCU), Psychoeducation
- Keywords
- Brief intervention, Behavioral intervention, Juvenile justice, Motivational enhancement
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational + Family Check-up (MET+FCU)Behavioural
In the MET session, motivational strategies of individualized normative feedback, examining decisional balance, and providing information/advice will be used to support goals for behavior change and to examine barriers to changes. There are four specific phases of the FCU session: (1) Self-assessment: Parents are asked if they learned anything about their family from participating in the assessment. (2) Support and clarification: The interviewer supports the parent's self-assessment efforts, assesses their level of understanding, and clarifies issues within the family. (3) Feedback: A summary form of the assessment is reviewed. (4) Action Plan: Throughout the session, the counselor works with the parent to develop a brief, written Action Plan about communication and monitoring.
PsychoeducationOther
Psychoeducation about substances is provided to teens and parents.
| Study group | Role | What they receive |
|---|---|---|
| Motivational + Family Check-up (MET+FCU) | Experimental | The MET individual session covers three constructs; 1) intentions to use marijuana; 2) normative beliefs about peer substance use; and 3) attitudes towards peer substance use. These same three constructs are also addressed with respect to truancy. In addition, motivation to abstain from substance use is discussed.
The FCU session with teens and parents/caregivers begins by collecting self-report measures and conducting a videotaped Family Assessment Task (FAsTask) to assess parent-teen interactions. The FAsTask is the basis of FCU feedback. There are four specific phases of the feedback session: 1) Self-assessment, 2) Support and clarification, 3) Feedback, and, 4) Action plan. Receives: Behavioral: Motivational + Family Check-up (MET+FCU) |
| Psychoeducation | Placebo comparator | An interventionist will review a set of educational materials with the parents regarding teen marijuana use, effects of marijuana on the brain, body and behavior, risks associated with marijuana use, how to tell if a teen is engaging in marijuana use or truancy, and parenting skills. A comparable set of materials will be reviewed with the adolescent. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Marijuana Use
Total number of marijuana use days .
Measured: Last 90 days at baseline, and 3, 6, and 12 months
Change in Quantity of Marijuana Use per Occasion of Use
Average quantity of marijuana use per day
Measured: Last 90 days at baseline and 3, 6, and 12 months
Secondary outcomes (2)
Change in Days truant from school
School attendance based on objective school records
Measured: Last 90 days at baseline, and 3, 6, and 12 months
Change in Days truant from school, self-report
School attendance based on self-report
Measured: Last 90 days at baseline, and 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jan 2019
- Primary completion30 Oct 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Problem BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Anthony Spirito, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655574
- Sponsor's protocol ID
- 1802001993
- Other IDs
- 1R01DA045396-01A1
- Acronym
- GOALS
- Status last verified
- May 2024
- First submitted
- 1 Aug 2018
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final study protocol will contain the information necessary to reproduce the findings in other populations. The protocol will include a copy of this grant application including Specific Aims and study population; recruitment and enrollment information; the measures collected and coding of the measures and subscales; the clinician intervention procedures; data analyses; syntax for data summary, and data analysis plans
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Individual and Parent Interventions for Substance Use in Truant Adolescents
- ClinicalTrials.gov ID
- NCT03655574
- Acronym / sponsor ID
- GOALS / 1802001993
- Conditions
- Adolescent Problem Behavior, Truancy; Unsocialized, Marijuana Abuse, Truancy; Socialized, Substance Abuse, Alcohol Abuse
- Keywords
- Brief intervention, Behavioral intervention, Juvenile justice, Motivational enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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 study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. It is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention.
Detailed description
Adolescents who use marijuana and are truant from school are a high-risk population with increased likelihood of substance use disorders, criminal justice involvement, and long-term impairments in vocational, family, and peer domains.
This study will test a theory-driven intervention for early adolescent marijuana using, truant youth identified through Rhode Island Truancy and Family Courts. Adolescents will be randomly assigned to one of the 2 conditions: a motivational interview versus psychoeducation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Motivational + Family Check-up (MET+FCU) | Experimental | Behavioral: Motivational + Family Check-up (MET+FCU)The MET individual session covers three constructs; 1) intentions to use marijuana; 2) normative beliefs about peer substance use; and 3) attitudes towards peer substance use. These same three constructs are also addressed with respect to truancy. In addition, motivation to abstain from substance use is discussed. The FCU session with teens and parents/caregivers begins by collecting self-report measures and conducting a videotaped Family Assessment Task (FAsTask) to assess parent-teen interactions. The FAsTask is the basis of FCU feedback. There are four specific phases of the feedback session: 1) Self-assessment, 2) Support and clarification, 3) Feedback, and, 4) Action plan. |
| Psychoeducation | Placebo comparator | Other: PsychoeducationAn interventionist will review a set of educational materials with the parents regarding teen marijuana use, effects of marijuana on the brain, body and behavior, risks associated with marijuana use, how to tell if a teen is engaging in marijuana use or truancy, and parenting skills. A comparable set of materials will be reviewed with the adolescent. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- the target child is in 6th-10th grade at the start of the project and living at home with at least one parent/guardian,
- the teen must report 6 or more incidences of marijuana use in the last 90 days (an approximation of biweekly use)
- by law, the teen must have at least 20 unexcused absences in an academic year to be in truancy court, and (4) parental consent and teen assent are obtained.
Key exclusion criteria (2 listed)
- the family is not able to speak and understand English or Spanish well enough to complete study procedures
- developmental delay, as determined by school placements outside the regular classroom, that would affect comprehension of the intervention.
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 |
|---|---|---|
| Motivational + Family Check-up (MET+FCU)In the MET session, motivational strategies of individualized normative feedback, examining decisional balance, and providing information/advice will be used to support goals for behavior change and to examine barriers to changes. There are four specific phases of the FCU session: (1) Self-assessment: Parents are asked if they learned anything about their family from participating in the assessment. (2) Support and clarification: The interviewer supports the parent's self-assessment efforts, assesses their level of understanding, and clarifies issues within the family. (3) Feedback: A summary form of the assessment is reviewed. (4) Action Plan: Throughout the session, the counselor works with the parent to develop a brief, written Action Plan about communication and monitoring. | Behavioural | Motivational + Family Check-up (MET+FCU) |
| PsychoeducationPsychoeducation about substances is provided to teens and parents. | Other | Psychoeducation |
Primary outcome
Change in Frequency of Marijuana Use
Time frame: Last 90 days at baseline, and 3, 6, and 12 months
Total number of marijuana use days .
Change in Quantity of Marijuana Use per Occasion of Use
Time frame: Last 90 days at baseline and 3, 6, and 12 months
Average quantity of marijuana use per day
2 secondary outcomes
Change in Days truant from school
Time frame: Last 90 days at baseline, and 3, 6, and 12 months
Change in Days truant from school, self-report
Time frame: Last 90 days at baseline, and 3, 6, and 12 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 3 Jun 2024.
- Individual participant dataSharing planned: Yes. The final study protocol will contain the information necessary to reproduce the findings in other populations. The protocol will include a copy of this grant application including Specific Aims and study population; recruitment and enrollment information; the measures collected and coding of the measures and subscales; the clinician intervention procedures; data analyses; syntax for data summary, and data analysis plans
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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, Ph.D. principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational + Family Check-up (MET+FCU) and Psychoeducation in people with Adolescent Problem Behavior and Truancy; Unsocialized, run by Brown 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 3 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 3 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Change in Frequency of Marijuana Use (time frame: Last 90 days at baseline, and 3, 6, and 12 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 3 Jun 2024.