Alcohol AbusePhase 2/3NCT00484367
A Comparison of Adolescent Group Therapy and Transitional Family Therapy for Adolescent Alcohol and Drug Abusers
A Phase 2/3 study testing Adolescent group therapy and Transitional family therapy in people with Alcohol Abuse and Alcohol Dependence, run by The Morton Center, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two psychosocially-based, manual-driven, behavioral modalities. One of these is a standardized version of the established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational and therapeutic components. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence, Cannabis Abuse
- What is being tested?
- Adolescent group therapy and Transitional family therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Aug 2012
- Phase
- Phase 2/3
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female outpatients 13-17 years of age at intake.
- Participants had a current DSM-IV diagnosis of either alcohol abuse or alcohol dependence.
- Participants signed a witnessed informed consent.
- Parent or custodian of each (adolescent) participant signed a witnessed informed consent.
Who cannot join
- Participants who met current DSM-IV criteria for bipolar disorder, psychotic disorder, or eating disorder.
- Enrollment in a residential substance abuse treatment program within 2 months prior to intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family and Group Therapies for Adolescent Alcohol Abuse
The purpose of this study is to compare the effectiveness of two psychosocially-based, manual-driven, behavioral modalities. One of these is a standardized version of the established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational and therapeutic components. The other is a state-of-the-art family therapy approach, Transitional Family Therapy (TFT), which integrates management of the current problem with exploration of multigenerational issues. Both approaches have been developed to expressly target adolescent alcohol problems.
Read the detailed description
Despite well-founded societal concerns over the use of illicit drugs by youth, alcohol use has persisted for decades as the number one adolescent substance abuse problem in the U.S. Further, research has shown that the earlier the onset of alcohol use, the more likely is a person to develop alcohol dependence later, during adulthood. Consequently, the need is clear for interventions which will arrest this process at the earliest point possible. Hence, interventions that mobilize a youth's social systems to help that young person deal with the problem, i.e., the family and peer systems, would make sense from a number of standpoints. Two primary modalities developed to deal with such issues are those examined here: family therapy and group therapy.
The participants were males and females, ages 13-17 at intake, with a DSM-IV diagnosis of either alcohol abuse or alcohol dependence. Following random assignment to condition, basic treatment in both conditions was based on a 12-session model and took approximately 3-4 months, followed by 1-2 aftercare sessions over an additional 1-2 months. The treatment was provided by therapists who were already working within the community (as opposed, for instance, to graduate students). Follow-up assessments were obtained at 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment, thus allowing determination of the extent to which treatment effects "held up" to a degree not attained by most of the previous outcome studies within this domain.
Comparisons: AGT and TFT are being compared on the extent to which their participants used alcohol, as well as other substances, during the three post-treatment periods. Other comparisons include school performance (grade point average), family relations/functioning, and involvement with the legal system.
- Conditions
- Alcohol Abuse, Alcohol Dependence, Cannabis Abuse, Cannabis Dependence, Other Substance Abuse
- Being tested
- Adolescent group therapy, Transitional family therapy
- Keywords
- Alcohol abuse, Substance abuse, Cannabis abuse, Adolescents, Group therapy, Family therapy
- Medical subject headings
- Alcoholism, Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent group therapyBehavioural
Adolescent group therapy
Transitional family therapyBehavioural
Transitional family therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 AGT | Active comparator | Not described Receives: Behavioral: Adolescent group therapy |
| 2 TFT | Active comparator | Not described Receives: Behavioral: Transitional family therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use Cannabis use Other substance use
Measured: Baseline, 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJul 1999
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Morton Center, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Morris D. Stanton, PhD, Principal investigator, The Morton Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484367
- Sponsor's protocol ID
- NIAAA-STA12178
- Other IDs
- R01AA012178, NIH Grant R01 AA12178
- Status last verified
- Nov 2008
- First submitted
- 7 Jun 2007
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family and Group Therapies for Adolescent Alcohol Abuse
- ClinicalTrials.gov ID
- NCT00484367
- Acronym / sponsor ID
- NIAAA-STA12178
- Conditions
- Alcohol Abuse, Alcohol Dependence, Cannabis Abuse, Cannabis Dependence, Other Substance Abuse
- Keywords
- Alcohol abuse, Substance abuse, Cannabis abuse, Adolescents, Group therapy, Family therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Morton Center, Inc.University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 1999
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 8 Jun 2007 (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 compare the effectiveness of two psychosocially-based, manual-driven, behavioral modalities. One of these is a standardized version of the established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational and therapeutic components. The other is a state-of-the-art family therapy approach, Transitional Family Therapy (TFT), which integrates management of the current problem with exploration of multigenerational issues. Both approaches have been developed to expressly target adolescent alcohol problems.
Detailed description
Despite well-founded societal concerns over the use of illicit drugs by youth, alcohol use has persisted for decades as the number one adolescent substance abuse problem in the U.S. Further, research has shown that the earlier the onset of alcohol use, the more likely is a person to develop alcohol dependence later, during adulthood. Consequently, the need is clear for interventions which will arrest this process at the earliest point possible. Hence, interventions that mobilize a youth's social systems to help that young person deal with the problem, i.e., the family and peer systems, would make sense from a number of standpoints. Two primary modalities developed to deal with such issues are those examined here: family therapy and group therapy.
The participants were males and females, ages 13-17 at intake, with a DSM-IV diagnosis of either alcohol abuse or alcohol dependence. Following random assignment to condition, basic treatment in both conditions was based on a 12-session model and took approximately 3-4 months, followed by 1-2 aftercare sessions over an additional 1-2 months. The treatment was provided by therapists who were already working within the community (as opposed, for instance, to graduate students). Follow-up assessments were obtained at 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment, thus allowing determination of the extent to which treatment effects "held up" to a degree not attained by most of the previous outcome studies within this domain.
Comparisons: AGT and TFT are being compared on the extent to which their participants used alcohol, as well as other substances, during the three post-treatment periods. Other comparisons include school performance (grade point average), family relations/functioning, and involvement with the legal system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 AGT | Active comparator | Behavioral: Adolescent group therapy |
| 2 TFT | Active comparator | Behavioral: Transitional family therapy |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female outpatients 13-17 years of age at intake.
- Participants had a current DSM-IV diagnosis of either alcohol abuse or alcohol dependence.
- Participants signed a witnessed informed consent.
- Parent or custodian of each (adolescent) participant signed a witnessed informed consent.
Key exclusion criteria (2 listed)
- Participants who met current DSM-IV criteria for bipolar disorder, psychotic disorder, or eating disorder.
- Enrollment in a residential substance abuse treatment program within 2 months prior to intake.
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 |
|---|---|---|
| Adolescent group therapyAdolescent group therapy | Behavioural | 1 AGT |
| Transitional family therapyTransitional family therapy | Behavioural | 2 TFT |
Primary outcome
Alcohol use Cannabis use Other substance use
Time frame: Baseline, 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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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.
Morris D. Stanton, PhD principal investigator
The Morton Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adolescent group therapy and Transitional family therapy in people with Alcohol Abuse and Alcohol Dependence, run by The Morton Center, Inc. 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: status not confirmed, as of the sponsor's last update on 26 Aug 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Alcohol use Cannabis use Other substance use (time frame: Baseline, 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment). 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 26 Aug 2011.