Substance AbusePhase 1TransitionsNCT00680381
Transitional Treatment of Adolescents in Family Therapy
A Phase 1 study testing MTI, Minimal Transitional Intervention, GTI, Group Transitional Intervention and STI, Systems Transitions Intervention in people with Substance Abuse, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. Adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- MTI, Minimal Transitional Intervention, GTI, Group Transitional Intervention and STI, Systems Transitions Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jul 2014
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- At least one parent, step-parent, or surrogate parent willing to participate in the study
- 13 to 18 years if age
- meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
- Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND
- Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).
Who cannot join
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
- Adolescent deemed dangerous to self or others during evaluation
- Services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification)
- Adolescent already has participated in treatment project at CFAR; AND
- A sibling is already participating in project.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)
Albuquerque, New Mexico, 87102
About this study
The purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. Adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week follow-up treatments: phone calls from a project therapist, group therapy, or a customized schedule of therapist visits with the adolescent, the adolescent's family and teachers, coaches, probation officers and others who can help the adolescent reach or maintain abstinence. Families are assessed using questionnaires and interviews before, during and after treatment, to provide information about family functioning, the adolescent's drug use, the adolescent's peers and other factors that may contribute to treatment success or failure. Adolescents also provide urine specimens for drug screening at assessment visits. Study investigators expect the study will show that a functional family environment and insulating adolescents from the influence of peers who use drugs will help prevent relapse for adolescents who have received family therapy.
- Conditions
- Substance Abuse
- Being tested
- MTI, Minimal Transitional Intervention, GTI, Group Transitional Intervention, STI, Systems Transitions Intervention
- Keywords
- adolescent substance abuse
- 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.
MTI, Minimal Transitional InterventionBehavioural
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.
GTI, Group Transitional InterventionBehavioural
Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.
STI, Systems Transitions InterventionBehavioural
Following 12 weeks of FFT, an individualized eight-week series of therapist meetings with the adolescent, family, police, teachers, coaches and others who can support the adolescent's reduced drug use.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Following 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks. Receives: Behavioral: MTI, Minimal Transitional Intervention |
| 2 | Active comparator | Following 12 weeks of FFT, weekly one-hour group therapy for eight weeks Receives: Behavioral: GTI, Group Transitional Intervention |
| 3 | Active comparator | Following 12 weeks of FFT, an eight-week, customized series of therapist visits with the adolescent, family, teachers, coaches and others who can support the adolescent's reduced level of drug use. Receives: Behavioral: STI, Systems Transitions Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens
Measured: pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJan 2004
- Primary completionJul 2014
- Study completionJul 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly B. Waldron, Ph.D., Principal investigator, Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680381
- Sponsor's protocol ID
- DA15762
- Other IDs
- R01DA015762
- Acronym
- Transitions
- Status last verified
- Aug 2014
- First submitted
- 16 May 2008
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Treatment of Adolescents in Family Therapy
- ClinicalTrials.gov ID
- NCT00680381
- Acronym / sponsor ID
- Transitions / DA15762
- Conditions
- Substance Abuse
- Keywords
- adolescent substance abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 May 2008 (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 purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. Adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week follow-up treatments: phone calls from a project therapist, group therapy, or a customized schedule of therapist visits with the adolescent, the adolescent's family and teachers, coaches, probation officers and others who can help the adolescent reach or maintain abstinence. Families are assessed using questionnaires and interviews before, during and after treatment, to provide information about family functioning, the adolescent's drug use, the adolescent's peers and other factors that may contribute to treatment success or failure. Adolescents also provide urine specimens for drug screening at assessment visits. Study investigators expect the study will show that a functional family environment and insulating adolescents from the influence of peers who use drugs will help prevent relapse for adolescents who have received family therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: MTI, Minimal Transitional InterventionFollowing 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks. |
| 2 | Active comparator | Behavioral: GTI, Group Transitional InterventionFollowing 12 weeks of FFT, weekly one-hour group therapy for eight weeks |
| 3 | Active comparator | Behavioral: STI, Systems Transitions InterventionFollowing 12 weeks of FFT, an eight-week, customized series of therapist visits with the adolescent, family, teachers, coaches and others who can support the adolescent's reduced level of drug use. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- At least one parent, step-parent, or surrogate parent willing to participate in the study
- 13 to 18 years if age
- meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
- Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND
- Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).
Key exclusion criteria (5 listed)
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
- Adolescent deemed dangerous to self or others during evaluation
- Services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification)
- Adolescent already has participated in treatment project at CFAR; AND
- A sibling is already participating in project.
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 |
|---|---|---|
| MTI, Minimal Transitional InterventionFollowing 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks. | Behavioural | 1 |
| GTI, Group Transitional InterventionFollowing 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks. | Behavioural | 2 |
| STI, Systems Transitions InterventionFollowing 12 weeks of FFT, an individualized eight-week series of therapist meetings with the adolescent, family, police, teachers, coaches and others who can support the adolescent's reduced drug use. | Behavioural | 3 |
Primary outcome
Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens
Time frame: pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session
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 5 Aug 2014.
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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.
Holly B. Waldron, Ph.D. principal investigator
Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
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 MTI, Minimal Transitional Intervention, GTI, Group Transitional Intervention and STI, Systems Transitions Intervention in people with Substance Abuse, run by Oregon Research Institute 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 5 inclusion and 5 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 5 Aug 2014. 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?
Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens (time frame: pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session). 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 5 Aug 2014.