Substance AbuseJJMISCOPENCT03107117
Computer-Assisted Brief Intervention
A study testing Computer Counseling in people with Substance Abuse, run by Brown University at 1 site in United States.
Trial summary
Due to the "unmet needs" of substance abuse treatment among court involved but non-incarcerated (CINI) adolescents and their parents, reaching and engaging CINI adolescents in intervention programs addressing marijuana use is important given the significant risk that continued substance use poses for re-arrest and… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Computer Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 30 Dec 2022
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- teen age 14 to 17, inclusive, living at home with at least one parent/guardian
- teen report of history of marijuana use and a positive brief screen during intake procedures * parental consent/ child assent; and, 4) one parent willing to participate in intervention
Who cannot join
- developmental delay
- teen or parents are not able to adequately speak and understand English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Family Court
Providence, Rhode Island, 02903
About this study
Official title: Computer-Assisted Brief Intervention Protocol for Marijuana Using Juvenile Offenders
Due to the "unmet needs" of substance abuse treatment among court involved but non-incarcerated (CINI) adolescents and their parents, reaching and engaging CINI adolescents in intervention programs addressing marijuana use is important given the significant risk that continued substance use poses for re-arrest and detention. This study will examine the feasibility of implementing one potential model for increasing access to substance use interventions in a juvenile justice setting by using: 1) a computer- assisted intervention addressing marijuana use for adolescents, and 2) a computer program on strategies to improve management of teens who misuse drugs for parents.
Read the detailed description
Four out of five youth in the juvenile justice system show evidence of being under the influence during their offenses, and over half test positive for substances at the time of their arrest. Further, 92% of arrested juveniles who tested positive for drugs tested positive for marijuana. Although some treatment programs for juvenile offenders exist, most have focused on detained and incarcerated juveniles, who only represent one third of arrested youth. As a result, little is known about how to improve the continuum of care for the remaining two-thirds of this population, which consists of court involved but non-incarcerated youth (CINI). Court recommendations and referrals for CINI have mostly relied on outside community-based services, thus decreasing the likelihood CINI youth and their families will take the additional steps to seek intervention. Given that motivational interventions (MI) are brief, relatively easy to implement and have a greater reach than typical substance use treatment programs, researchers have recently directed their focus to interactive, computer-delivered MI protocols to further increase their reach as well as facilitate their implementation. Online interventions can be delivered at a lower cost, with less demand on staff time for training, and increased protocol fidelity, portability, and ease of use. While counselor-delivered MIs for adolescent substance use have been tested fairly widely, only a few studies have been published on the efficacy of computer-assisted MIs. Further, little research has focused on the efficacy of such interventions with marijuana using adolescents in general, and more specifically with CINI adolescents. In addition, combining such interventions for adolescents with brief parenting interventions is important but yet rarely implemented. Therefore, this application proposes to examine the feasibility and acceptability of integrating a computer-assisted,, brief intervention protocol into the juvenile intake procedures at the Rhode Island Family Court (RIFC) for marijuana using adolescents and their parents. Following an open trial of the brief protocol, , 80 adolescents who screen positive for marijuana use at juvenile intake will be recruited from the RIFC and randomly assigned to one of two conditions: 1) a computer-assisted adolescent MI plus an online parenting program ; or 2) usual care. Outcomes will be examined at 3 and 6-month follow-ups. This small trial will provide some initial evidence regarding utility of this protocol with CINI youth and whether a larger, fully powered trial is indicated in the future.
- Conditions
- Substance Abuse
- Being tested
- Computer Counseling, Standard Care
- 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.
Computer CounselingBehavioural
two computer counseling online programs for a teen and a parent
Standard CareBehavioural
A referral for substance use counseling
| Study group | Role | What they receive |
|---|---|---|
| Computer counseling | Experimental | a computer-assisted adolescent motivational intervention called e-toke plus an online parenting program - Parenting Wisely Receives: Behavioral: Computer Counseling |
| Standard care | Active comparator | Standard care is typically referral to counseling for substance use Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back Interview (TLFB)
The Timeline Follow-back Interview is a widely used research tool with good reliability and validity for various groups of individuals. Marijuana and alcohol consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when marijuana and alcohol were used. Data from the TLFB will be summarized to yield the total number of marijuana and alcohol use days.
Measured: 90 days
Secondary outcomes (1)
Marijuana and alcohol problems
Marijuana and alcohol use problems will be assessed using items from the Add Health longitudinal study on symptoms of abuse and dependence including problems at school, home; physical fights; and physical symptoms such as vomiting and "hang over."
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Oct 2017
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a computer-assisted adolescent motivational interview plus an online parenting program for substance abuse will be compared to usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 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
- NCT03107117
- Sponsor's protocol ID
- DA042247
- Acronym
- JJMISCOPE
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2017
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analysis files will be constructed from the stored electronic data and will be stripped of identifying information with the Safe Harbor method. Specifically, youth and their parents will be identified with a family identifier and person identifier number that is randomly generated and not related to any element of their personal identifying information. No names, addresses, telephone numbers, fax numbers, email addresses, social security numbers, medical records, etc. will be retained. Dates will contain only year and a randomly generated day-of-the-year. We will only share it with external investigators when a data use agreement (DUA) is executed between the Brown University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction. The data will be made available on April 1, 2021 by the PI
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Brief Intervention Protocol for Marijuana Using Juvenile Offenders
- ClinicalTrials.gov ID
- NCT03107117
- Acronym / sponsor ID
- JJMISCOPE / DA042247
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Apr 2017 (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.
Due to the "unmet needs" of substance abuse treatment among court involved but non-incarcerated (CINI) adolescents and their parents, reaching and engaging CINI adolescents in intervention programs addressing marijuana use is important given the significant risk that continued substance use poses for re-arrest and detention. This study will examine the feasibility of implementing one potential model for increasing access to substance use interventions in a juvenile justice setting by using: 1) a computer- assisted intervention addressing marijuana use for adolescents, and 2) a computer program on strategies to improve management of teens who misuse drugs for parents.
Detailed description
Four out of five youth in the juvenile justice system show evidence of being under the influence during their offenses, and over half test positive for substances at the time of their arrest. Further, 92% of arrested juveniles who tested positive for drugs tested positive for marijuana. Although some treatment programs for juvenile offenders exist, most have focused on detained and incarcerated juveniles, who only represent one third of arrested youth. As a result, little is known about how to improve the continuum of care for the remaining two-thirds of this population, which consists of court involved but non-incarcerated youth (CINI). Court recommendations and referrals for CINI have mostly relied on outside community-based services, thus decreasing the likelihood CINI youth and their families will take the additional steps to seek intervention. Given that motivational interventions (MI) are brief, relatively easy to implement and have a greater reach than typical substance use treatment programs, researchers have recently directed their focus to interactive, computer-delivered MI protocols to further increase their reach as well as facilitate their implementation. Online interventions can be delivered at a lower cost, with less demand on staff time for training, and increased protocol fidelity, portability, and ease of use. While counselor-delivered MIs for adolescent substance use have been tested fairly widely, only a few studies have been published on the efficacy of computer-assisted MIs. Further, little research has focused on the efficacy of such interventions with marijuana using adolescents in general, and more specifically with CINI adolescents. In addition, combining such interventions for adolescents with brief parenting interventions is important but yet rarely implemented. Therefore, this application proposes to examine the feasibility and acceptability of integrating a computer-assisted,, brief intervention protocol into the juvenile intake procedures at the Rhode Island Family Court (RIFC) for marijuana using adolescents and their parents. Following an open trial of the brief protocol, , 80 adolescents who screen positive for marijuana use at juvenile intake will be recruited from the RIFC and randomly assigned to one of two conditions: 1) a computer-assisted adolescent MI plus an online parenting program ; or 2) usual care. Outcomes will be examined at 3 and 6-month follow-ups. This small trial will provide some initial evidence regarding utility of this protocol with CINI youth and whether a larger, fully powered trial is indicated in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a computer-assisted adolescent motivational interview plus an online parenting program for substance abuse will be compared to usual care.
| Arm | Type | Receives |
|---|---|---|
| Computer counseling | Experimental | Behavioral: Computer Counselinga computer-assisted adolescent motivational intervention called e-toke plus an online parenting program - Parenting Wisely |
| Standard care | Active comparator | Behavioral: Standard CareStandard care is typically referral to counseling for substance use |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- teen age 14 to 17, inclusive, living at home with at least one parent/guardian
- teen report of history of marijuana use and a positive brief screen during intake procedures * parental consent/ child assent; and, 4) one parent willing to participate in intervention
Key exclusion criteria (2 listed)
- developmental delay
- teen or parents are not able to adequately speak and understand English or Spanish.
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 |
|---|---|---|
| Computer Counselingtwo computer counseling online programs for a teen and a parent | Behavioural | Computer counseling |
| Standard CareA referral for substance use counseling | Behavioural | Standard care |
Primary outcome
Time Line Follow Back Interview (TLFB)
Time frame: 90 days
The Timeline Follow-back Interview is a widely used research tool with good reliability and validity for various groups of individuals. Marijuana and alcohol consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when marijuana and alcohol were used. Data from the TLFB will be summarized to yield the total number of marijuana and alcohol use days.
1 secondary outcome
Marijuana and alcohol problems
Time frame: 90 days
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 Mar 2023.
- Individual participant dataSharing planned: Yes. Analysis files will be constructed from the stored electronic data and will be stripped of identifying information with the Safe Harbor method. Specifically, youth and their parents will be identified with a family identifier and person identifier number that is randomly generated and not related to any element of their personal identifying information. No names, addresses, telephone numbers, fax numbers, email addresses, social security numbers, medical records, etc. will be retained. Dates will contain only year and a randomly generated day-of-the-year. We will only share it with external investigators when a data use agreement (DUA) is executed between the Brown University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction. The data will be made available on April 1, 2021 by the PI
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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 study testing Computer Counseling in people with Substance Abuse, 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 2 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 7 Mar 2023. 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?
Time Line Follow Back Interview (TLFB) (time frame: 90 days). 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 7 Mar 2023.