Cognitive Stimulation in Adolescents | NCT01948674

Studies
Cognitive Stimulation in Adolescents

NCT01948674

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Aug 24, 2016Estimated

Enrollment

87Actual

Phase

Phase 2

Conditions

Substance Use Disorders

Interventions

Computerized tasks

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
R21DA034942	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2016

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

Oct 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 17, 2013

First Submission Date that Met QC Criteria

Sep 19, 2013

First Posted Date

Sep 23, 2013Estimated

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

Aug 22, 2016

Last Update Posted Date

Aug 24, 2016Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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 see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks.

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

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
computerized tasks- adaptive	Experimental		Behavioral: Computerized tasks
computerized tasks - nonadaptive	Active Comparator		Behavioral: Computerized tasks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computerized tasks	Behavioral	The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
working memory (change from baseline)		expected within 2 weeks after intervention

Secondary Outcomes

Measure	Description	Time Frame
timeline follow back (change from baseline)		expected within 2 weeks after intervention
delay discounting (change from baseline)		expected within 2 weeks after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 14-21
Diagnosis of substance use disorder (SUD) by DSM-IV criteria with marijuana as primary substance of abuse
eligible for intensive outpatient treatment

Exclusion Criteria:

Untreated psychiatric disorder that might make participation hazardous
Any condition associated with severe cognitive impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew W Johnson, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mountain Manor Treatment Center		Baltimore	Maryland	21229	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