Substance-Related DisordersPhase 2VIDANCT01018654
Validating Interventions for Diverse Adolescents
A Phase 2 study testing Standard Cognitive Behavioral Treatment and Culturally Adapted Cognitive-Behavioral Treatment in people with Substance-Related Disorders, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Standard Cognitive Behavioral Treatment and Culturally Adapted Cognitive-Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Feb 2013
- Phase
- Phase 2
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent between 13-18 years of age
- Parental consent
- Adolescent speaks English and Spanish
- Adolescent assent to participate in treatment and assessments
- Adolescent meets either DSM-IV diagnostic criteria for substance abuse or dependence
- Adolescent identifies as Hispanic
Who cannot join
- Adolescent younger than 13 or older than 18 years of age
- Adolescent requires higher level of care than what is provided in study
- Adolescent speaks only English or Spanish
- Parental consent not obtainable
- Adolescent does not assent to study
- Adolescent is overtly psychotic, severely depressed/suicidal, and/or presents with other mental disorder that will limit participation in group treatment
- Adolescent has completed substance abuse treatment elsewhere in the past 90 days
- Adolescent does not identify as Hispanic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Group Treatment for Hispanic Adolescents - RCT
The purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents.
- Conditions
- Substance-Related Disorders
- Being tested
- Standard Cognitive Behavioral Treatment, Culturally Adapted Cognitive-Behavioral Treatment
- Keywords
- Substance Abuse, Substance Addiction
- 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.
Standard Cognitive Behavioral TreatmentBehavioural
Standard CBT for Substance Abuse
Culturally Adapted Cognitive-Behavioral TreatmentBehavioural
Culturally Adapted CBT for Substance Abuse
| Study group | Role | What they receive |
|---|---|---|
| Culturally Adapted Cognitive-Behavioral Treatment | Experimental | Culturally Adapted CBT for Substance Abuse Receives: Behavioral: Culturally Adapted Cognitive-Behavioral Treatment |
| Standard Cognitive-Behavioral Treatment | Active comparator | Standard Cognitive-Behavioral Treatment for Substance Abuse Receives: Behavioral: Standard Cognitive Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use Levels
Measured: Posttreatment, 3, 6, 12-month follow-ups
Secondary outcomes (1)
Satisfaction with Treatment
Measured: Posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJun 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018654
- Sponsor's protocol ID
- IRB_00041220
- Other IDs
- K23DA019914, 5K23DA19914-5
- Acronym
- VIDA
- Status last verified
- Apr 2013
- First submitted
- 23 Nov 2009
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Group Treatment for Hispanic Adolescents - RCT
- ClinicalTrials.gov ID
- NCT01018654
- Acronym / sponsor ID
- VIDA / IRB_00041220
- Conditions
- Substance-Related Disorders
- Keywords
- Substance Abuse, Substance Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Nov 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 purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Adapted Cognitive-Behavioral Treatment | Experimental | Behavioral: Culturally Adapted Cognitive-Behavioral TreatmentCulturally Adapted CBT for Substance Abuse |
| Standard Cognitive-Behavioral Treatment | Active comparator | Behavioral: Standard Cognitive Behavioral TreatmentStandard Cognitive-Behavioral Treatment for Substance Abuse |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adolescent between 13-18 years of age
- Parental consent
- Adolescent speaks English and Spanish
- Adolescent assent to participate in treatment and assessments
- Adolescent meets either DSM-IV diagnostic criteria for substance abuse or dependence
Key exclusion criteria (8 listed)
- Adolescent younger than 13 or older than 18 years of age
- Adolescent requires higher level of care than what is provided in study
- Adolescent speaks only English or Spanish
- Parental consent not obtainable
- Adolescent does not assent to study
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 |
|---|---|---|
| Standard Cognitive Behavioral TreatmentStandard CBT for Substance Abuse | Behavioural | Standard Cognitive-Behavioral Treatment |
| Culturally Adapted Cognitive-Behavioral TreatmentCulturally Adapted CBT for Substance Abuse | Behavioural | Culturally Adapted Cognitive-Behavioral Treatment |
Primary outcome
Substance Use Levels
Time frame: Posttreatment, 3, 6, 12-month follow-ups
1 secondary outcome
Satisfaction with Treatment
Time frame: Posttreatment
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 18 Apr 2023.
Related trials for Substance-Related Disorders
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Cognitive Behavioral Treatment and Culturally Adapted Cognitive-Behavioral Treatment in people with Substance-Related Disorders, run by University of Utah 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 6 inclusion and 8 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 18 Apr 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.
What does this 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.
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?
Substance Use Levels (time frame: Posttreatment, 3, 6, 12-month follow-ups). 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 18 Apr 2023.