Validating Interventions for Diverse Adolescents | NCT01018654

Studies
Validating Interventions for Diverse Adolescents

NCT01018654

Sponsor

University of Utah

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

70Actual

Phase

Phase 2

Conditions

Substance-Related Disorders

Interventions

Standard Cognitive Behavioral Treatment
Culturally Adapted Cognitive-Behavioral Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K23DA019914	U.S. NIH Grant/Contract		View source
5K23DA19914-5

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Nov 23, 2009

First Submission Date that Met QC Criteria

Nov 23, 2009

First Posted Date

Nov 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2023

Last Update Posted Date

Apr 18, 2023Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Culturally Adapted Cognitive-Behavioral Treatment	Experimental	Culturally Adapted CBT for Substance Abuse	Behavioral: Culturally Adapted Cognitive-Behavioral Treatment
Standard Cognitive-Behavioral Treatment	Active Comparator	Standard Cognitive-Behavioral Treatment for Substance Abuse	Behavioral: Standard Cognitive Behavioral Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Cognitive Behavioral Treatment	Behavioral	Standard CBT for Substance Abuse	Standard Cognitive-Behavioral Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Substance Use Levels		Posttreatment, 3, 6, 12-month follow-ups

Secondary Outcomes

Measure	Description	Time Frame
Satisfaction with Treatment		Posttreatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah		Salt Lake City	Utah	84112	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided