Adolescent Substance AbuseCASALEAPNCT00985595
Learning Effective Approaches to Prevention
An observational study of Adolescent Substance Abuse, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
Trial summary
The objective of the study is to test the effectiveness, implementation quality, and cost effectiveness of family-based treatment services for adolescent substance abuse delivered in an agency setting. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Adolescent Substance Abuse
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2012
- Phase
- Observational
- 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
Study population: Adolescents screened for symptoms of substance abuse/dependence, and their families, will participate in the study. Participants will include 260 male and female adolescents who complete the enrollment process, meet eligibility criteria, and consent to be randomized into one of two study conditions. Youth will be referred primarily from two sources: juvenile justice agencies and local schools/community programs. Based on the demographics of adolescents currently participating in partner sites, youth are likely to be predominantly male (69%), Hispanic (68%), and African American (32%). Families are generally low income from disadvantaged neighborhoods, with high rates of family mental health and substance use problems.
Who may be able to join
- ages 13 and 17,
- have a caregiver willing to participate in treatment,
- meet ASAM criteria for outpatient or intensive outpatient substance abuse treatment,
- not receiving any other behavioral treatment, and
- have public or private health benefits that meet standard community clinic registration requirements.
Who cannot join
- mental retardation,
- pervasive developmental disorder,
- medical or psychiatric illness requiring hospitalization,
- current psychotic features, or
- current suicidality (Ideation + Plan + High Intention).
Trial locations and contacts
1 site in 1 country.
United States1 site
The National Center on Addiction and Substance Abuse at Columbia University
New York, New York, 10017
About this study
Official title: Quality Community Services for Adolescent Drug Abuse
The objective of the study is to test the effectiveness, implementation quality, and cost effectiveness of family-based treatment services for adolescent substance abuse delivered in an agency setting.
Read the detailed description
Despite the success of family-based ecological interventions (FBEI) in controlled trials, this highly promising services approach has not been tested under pure field conditions with ASA populations. Controlled effectiveness research invariably enhances training, supervision, and service delivery conditions in partnering sites in an effort to ensure treatment adherence and consistency. An alternative strategy for advancing dissemination science is rigorous naturalistic research on community clinics that already implement evidence-based practices in the course of routine care. The proposed study will follow this "bottom up" strategy by investigating the quality and impact of ASA services delivered by front-line therapists in a community-based mental health center that already features FBEI as the routine standard of care. The study will use a randomized design to compare naturalistic FBEI services to services as usual (SAU) for ASA. Participants (N = 260) will be recruited from local high schools, enrichment programs, and juvenile justice programs. Eligible adolescents will meet ASAM criteria for outpatient treatment. The SAU condition will contain the three most common service venues for ASA in urban communities: hospital-based ambulatory mental health clinics, drug counseling/addictions specialty clinics, and community mental health centers. The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI Stage II efficacy trial. The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU. A multitrait, multimethod assessment design will include adolescent and parent interviews at baseline and 3, 6, and 12 months follow-up. Cost and service utilization data will be collected from self report and from provider agencies in both conditions. The study will yield the first evidence on whether a widely endorsed treatment approach for ASA is potent and feasible in real-world conditions and superior to SAU in outcomes and cost-benefit. An important secondary yield will be increasing the scarce knowledge base on commonly practiced community approaches in the SAU condition.
- Conditions
- Adolescent Substance Abuse
- Keywords
- Adolescent, substance abuse
- Medical subject headings
- Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI efficacy trial.
Measured: 3, 6, 12 months after baseline
Secondary outcomes (1)
The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU.
Measured: 3, 6, 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startJan 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Hogue, The National Center on Addiction and Substance Abuse at Columbia University
- Investigators
- Aaron Hogue, Ph.D., Principal investigator, The National Center on Addiction and Substance Abuse at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985595
- Sponsor's protocol ID
- 165
- Other IDs
- 1R01DA019607-01
- Acronym
- CASALEAP
- Status last verified
- Aug 2015
- First submitted
- 25 Sep 2009
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mattos LA, Schmidt AT, Henderson CE, Hogue A. Therapeutic alliance and treatment outcome in the outpatient treatment of urban adolescents: The role of callous-unemotional traits. Psychotherapy (Chic). 2017 Jun;54(2):136-147. doi: 10.1037/pst0000093. Epub 2016 Nov 10.
PubMed 27831697
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Community Services for Adolescent Drug Abuse
- ClinicalTrials.gov ID
- NCT00985595
- Acronym / sponsor ID
- CASALEAP / 165
- Conditions
- Adolescent Substance Abuse
- Keywords
- Adolescent, substance abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Sep 2009 (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 objective of the study is to test the effectiveness, implementation quality, and cost effectiveness of family-based treatment services for adolescent substance abuse delivered in an agency setting.
Detailed description
Despite the success of family-based ecological interventions (FBEI) in controlled trials, this highly promising services approach has not been tested under pure field conditions with ASA populations. Controlled effectiveness research invariably enhances training, supervision, and service delivery conditions in partnering sites in an effort to ensure treatment adherence and consistency. An alternative strategy for advancing dissemination science is rigorous naturalistic research on community clinics that already implement evidence-based practices in the course of routine care. The proposed study will follow this "bottom up" strategy by investigating the quality and impact of ASA services delivered by front-line therapists in a community-based mental health center that already features FBEI as the routine standard of care. The study will use a randomized design to compare naturalistic FBEI services to services as usual (SAU) for ASA. Participants (N = 260) will be recruited from local high schools, enrichment programs, and juvenile justice programs. Eligible adolescents will meet ASAM criteria for outpatient treatment. The SAU condition will contain the three most common service venues for ASA in urban communities: hospital-based ambulatory mental health clinics, drug counseling/addictions specialty clinics, and community mental health centers. The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI Stage II efficacy trial. The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU. A multitrait, multimethod assessment design will include adolescent and parent interviews at baseline and 3, 6, and 12 months follow-up. Cost and service utilization data will be collected from self report and from provider agencies in both conditions. The study will yield the first evidence on whether a widely endorsed treatment approach for ASA is potent and feasible in real-world conditions and superior to SAU in outcomes and cost-benefit. An important secondary yield will be increasing the scarce knowledge base on commonly practiced community approaches in the SAU condition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescents screened for symptoms of substance abuse/dependence, and their families, will participate in the study. Participants will include 260 male and female adolescents who complete the enrollment process, meet eligibility criteria, and consent to be randomized into one of two study conditions. Youth will be referred primarily from two sources: juvenile justice agencies and local schools/community programs. Based on the demographics of adolescents currently participating in partner sites, youth are likely to be predominantly male (69%), Hispanic (68%), and African American (32%). Families are generally low income from disadvantaged neighborhoods, with high rates of family mental health and substance use problems.
Key inclusion criteria (5 listed)
- ages 13 and 17,
- have a caregiver willing to participate in treatment,
- meet ASAM criteria for outpatient or intensive outpatient substance abuse treatment,
- not receiving any other behavioral treatment, and
- have public or private health benefits that meet standard community clinic registration requirements.
Key exclusion criteria (5 listed)
- mental retardation,
- pervasive developmental disorder,
- medical or psychiatric illness requiring hospitalization,
- current psychotic features, or
- current suicidality (Ideation + Plan + High Intention).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI efficacy trial.
Time frame: 3, 6, 12 months after baseline
1 secondary outcome
The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU.
Time frame: 3, 6, 12 months after baseline
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 2015.
- Derived from this study: PubMed 27831697Mattos LA, Schmidt AT, Henderson CE, Hogue A. Therapeutic alliance and treatment outcome in the outpatient treatment of urban adolescents: The role of callous-unemotional traits. Psychotherapy (Chic). 2017 Jun;54(2):136-147. doi: 10.1037/pst0000093. Epub 2016 Nov 10.
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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.
Aaron Hogue, Ph.D. principal investigator
The National Center on Addiction and Substance Abuse at Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Substance Abuse, run by The National Center on Addiction and Substance Abuse at Columbia 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 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 2015. 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?
The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI efficacy trial. (time frame: 3, 6, 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985595, which also lists 1 linked publication.
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 2015; AzTrials last refreshed its copy on 28 Oct 2026.