Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT01751035
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2012-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2012-11-15', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in substance use problems (initiation/continuation, quantity, and abuse symptoms)', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'change in PTSD severity and symptoms', 'timeFrame': '18 months'}, {'measure': 'change in risky sexual behaviors', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PTSD', 'Alcohol Use Disorders', 'Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '32022827', 'type': 'DERIVED', 'citation': 'Danielson CK, Adams Z, McCart MR, Chapman JE, Sheidow AJ, Walker J, Smalling A, de Arellano MA. Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):574-586. doi: 10.1001/jamapsychiatry.2019.4803.'}]}, 'descriptionModule': {'briefSummary': "Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.", 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) 13-18 years old;\n* 2\\) Presenting to LCC/HH for evaluation or treatment;\n* 3\\) Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent\'s breasts or genitalia; or (d) respondents\' touching of another person\'s genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.\n* 4\\) Have a memory of the incident(s);\n* 5\\) Five or more DSM-IV PTSD symptoms;\n* 6\\) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.\n\nExclusion Criteria:\n\n* 1\\) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;\n* 2\\) Actively suicidal or homicidal;\n* 3\\) Reports active psychotic disorder'}, 'identificationModule': {'nctId': 'NCT01751035', 'acronym': 'RRFT', 'briefTitle': 'Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD', 'orgStudyIdInfo': {'id': 'Pro00009042'}, 'secondaryIdInfos': [{'id': 'R01DA031285-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DA031285-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment as Usual (TAU)', 'description': 'Treatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers. This could include individual and/or group therapy using a variety of treatment models.', 'interventionNames': ['Behavioral: Treatment as Usual']}, {'type': 'EXPERIMENTAL', 'label': 'RRFT', 'description': 'RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.', 'interventionNames': ['Behavioral: Risk Reduction through Family Therapy']}], 'interventions': [{'name': 'Risk Reduction through Family Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['RRFT'], 'description': 'RRFT is an integrative, ecologically-based approach to risk reduction and treatment. A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed. This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system. Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.', 'armGroupLabels': ['RRFT']}, {'name': 'Treatment as Usual', 'type': 'BEHAVIORAL', 'otherNames': ['TAU'], 'description': 'Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers. In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community. TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.', 'armGroupLabels': ['Treatment as Usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Carla K Danielson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}