Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-03-19 @ 4:42 PM
Study NCT ID:
NCT02622451
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differential Sensitivity Markers in Youth Drug Abuse Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed Discounting Task', 'timeFrame': '4 months post-intervention', 'description': 'Youth Computer Task'}, {'measure': 'Iowa Gambling Task', 'timeFrame': '4 months post-intervention', 'description': 'Youth Computer Task'}, {'measure': 'Urinalysis', 'timeFrame': '4 months post-intervention', 'description': 'Adolescents will provide urine samples for urinalysis to test for recent drug usage.'}, {'measure': 'Peer Substance Use Test', 'timeFrame': '4 months post-intervention', 'description': 'Youth Report'}, {'measure': 'Peer Delinquency Scale', 'timeFrame': '4 months post-intervention', 'description': 'Youth Report'}, {'measure': 'Project Towards No Drug Abuse Survey', 'timeFrame': '4 months post-intervention', 'description': 'Youth Report'}, {'measure': 'Alcohol Expectancy Questionnaire', 'timeFrame': '4 months post-intervention', 'description': 'Youth Report'}, {'measure': 'Single-item self-efficacy Scale', 'timeFrame': '4 months post-intervention', 'description': 'Youth Report'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': '4 months post-intervention', 'description': 'Parent \\& Youth Report'}, {'measure': 'Highly Sensitive Person Scale', 'timeFrame': '4 months post-intervention', 'description': 'Parent \\& Youth Report'}, {'measure': 'Parental Monitoring Instrument', 'timeFrame': '4 months post-intervention', 'description': 'Parent \\& Youth Report'}, {'measure': 'Parenting Relationship Questionnaire (PRQ)', 'timeFrame': '4 months post-intervention', 'description': 'Parent Report'}, {'measure': 'Family Problem Solving Communication Index', 'timeFrame': '4 months post-intervention', 'description': 'Parent Report'}, {'measure': 'Parental Locus of Control Questionnaire', 'timeFrame': '4 months post-intervention', 'description': 'Parent Report'}, {'measure': 'Family Assessment Measure - III', 'timeFrame': '4 months post-intervention', 'description': 'Parent Report on family functioning .'}, {'measure': 'Conflict Behavior Questionnaire', 'timeFrame': '4 months post-intervention', 'description': 'Parent Report'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Substance Use']}, 'descriptionModule': {'briefSummary': 'This pilot study conducts feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework that seeks to preempt the progression from early drug use to more chronic abuse and dependency. The study will explore moderators representing two frameworks, risk severity and differential sensitivity. Moderators will be explored in their ability to influence the differential efficacy of two adolescent drug abuse interventions.', 'detailedDescription': 'This R34 pilot study proposes to conduct feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework for early stage adolescent drug users. The study will explore putative moderators representing two theoretically distinct frameworks and determine whether they are suitable candidates for a subsequent R01 study. One moderation framework is based on risk severity (RS) as reflected by individual differences in delay discounting (DD), a form of impulsive decision making that is positively associated with escalation to more serious levels of abuse and addiction. A second more exploratory framework is based on differential sensitivity (DS) theory. The DS framework stipulates that individuals, due to specific sensitivity factors, vary in their responsiveness to environmental influence such as the influence provided by an intervention. The study will explore DS markers associated with the reward motivational system, including dopaminergic genes, the post-auricular physiological reflex and a high sensory-processing sensitivity trait. An agency-university partnership will collaborate in providing services to 120 adolescents (ages 12-17) who were referred to a community counseling center because of a recent alcohol and/or marijuana incident. Recruitment will select mild/moderate drug users. Participants will be randomized to one of two evidence-based drug abuse interventions. The two interventions offer the same delivery dosage but differ in terms of their mechanism of therapeutic change (i.e., degree of environmental influence). The Teen Intervene program (TI; Winters \\& Leitten, 2007) is a youth-focused intervention that uses motivational interviewing, goal setting, and skills training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors. The Everyday Parenting program (EP; Dishion et al., 2003; 2010) is a family focused-intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives to drug use. The aims of this R34 are to (1) assess feasibility of recruiting, assessing, and following-up enrolled youth in an intervention trial, (2) assess the ability of staff to implement TI and EP with fidelity, and (3) obtain promising data on moderator and outcome variables that will help answer the question of "what intervention works best for which youth" in a subsequent R01 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth ages 12-17\n* Substance Use referral to community partner agency\n* Adolescent report of weekly-monthly use of one or more substances within the prior 6 months\n\nExclusion Criteria:\n\n* Current DSM-5 diagnosis of a severe substance use disorder (i.e. substance dependence)\n* Adolescent report of daily use of substance within prior 6 months\n* Current or past history of psychosis (including suicidal ideation)\n* Pervasive developmental disabilities'}, 'identificationModule': {'nctId': 'NCT02622451', 'briefTitle': 'Differential Sensitivity Markers in Youth Drug Abuse Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Differential Sensitivity Markers in Youth Drug Abuse Prevention', 'orgStudyIdInfo': {'id': '1504S69041'}, 'secondaryIdInfos': [{'id': 'R34DA037888', 'link': 'https://reporter.nih.gov/quickSearch/R34DA037888', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Youth Behavioral Intervention', 'description': 'Teen Intervene', 'interventionNames': ['Behavioral: Teen Intervene']}, {'type': 'OTHER', 'label': 'Parent Education', 'description': 'Everyday Parenting', 'interventionNames': ['Behavioral: Everyday Parenting']}], 'interventions': [{'name': 'Teen Intervene', 'type': 'BEHAVIORAL', 'description': 'Teen Intervene (TI) is an early intervention program for 12-19 year olds who display early stages of alcohol or drug use. TI uses motivational interviewing, goal setting, and skill training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors.', 'armGroupLabels': ['Youth Behavioral Intervention']}, {'name': 'Everyday Parenting', 'type': 'BEHAVIORAL', 'description': 'Everyday Parenting is a family-focused intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives.', 'armGroupLabels': ['Parent Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Center for Personalized Prevention Research in Children's Mental Health", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Gerald August, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Natalis Counseling Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}