Viewing Study NCT02629068


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Study NCT ID: NCT02629068
Status: WITHDRAWN
Last Update Posted: 2019-04-22
First Post: 2015-11-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: PURPOSE: A Social Media Intervention for Parent Support
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants were enrolled in the pilot phase of the study due to lack of interest from parents. Completion dates reflect the end of funding for the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adolescent Treatment History and Parental Engagement Questionnaire', 'timeFrame': '8 weeks', 'description': "Parental report of child's treatment status, including enrollment date, primary reason for seeking treatment, and type of facility. All parents will also report on number of informal parent/family support groups (e.g., AlAnon) and formal treatment sessions they have attended (baseline and follow-up)."}], 'secondaryOutcomes': [{'measure': 'Perceived Stigma of Addiction Scale', 'timeFrame': '8 weeks', 'description': 'The PSAS is an 8-item self-report questionnaire designed to assess perceptions of the prevalence of stigmatizing beliefs towards individuals with substance use diagnoses and treatment histories (baseline and follow-up)'}, {'measure': 'Parental Monitoring Questionnaire', 'timeFrame': '8 weeks', 'description': "Relationship and disclosure constructs will be used from Stattin and Kerr's (2000) questionnaire of parental monitoring (baseline and follow-up)"}, {'measure': 'Satisfaction and Usability Questionnaire', 'timeFrame': '8 weeks', 'description': 'Participants will report overall satisfaction and degree to which information provided was deemed applicable and helpful. Likert-scale reports of satisfaction as well as responses to open-ended questions will be collected (PURPOSE intervention parents only and follow-up only).'}, {'measure': 'K-10 Scale of Psychological Distress', 'timeFrame': '8 weeks', 'description': 'The U.S. National Health Survey K-10 is a 10-item screening scale used to assess the degree of non-specific psychological distress over the past 30 days (baseline and follow-up)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent', 'Social Support', 'Social Media', 'Parents', 'Shame', 'Stigma'], 'conditions': ['Substance Use Disorders', 'Parenting']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to develop and test a social media-based (Facebook) intervention that provides support and skills to parents with adolescent children in treatment for substance abuse. The Facebook intervention, PURPOSE, will be 8 weeks long and led by other parents (peer leaders). Peer leaders will go through 2 2-3-hour training sessions and be assessed at the end to confirm their understanding of study protocol and procedures. The study PI will lead 2 short (2-weeks) trial tests of various segments of the intervention to test out content and procedures. Then, a pilot trial with 80 parents, 40 randomized to PURPOSE and 40 randomized to treatment as usual (TAU), will be done to test how useful PURPOSE can be in promoting parents' engagement in their child's treatment and recovery while reducing their own distress and feelings of shame/stigma. Parents will do a phone interview at the start of PURPOSE and again at the end of the 8 weeks.", 'detailedDescription': "This study will take advantage of established peer training techniques to train parents of adolescents who are more experienced to help other parents better engage in services for their adolescent child. This pilot study marks the beginning of our long-term program of research focused on adapting intervention tools for delivery via e-technology platforms as a means for optimizing treatment effectiveness for youth. Thus, the proposed study will contribute to the scientific literature on the role of parental support in adolescent recovery as well as respond to NIDA's call for increased understanding of the feasibility and utility of social media as an option expanding the traditional treatment and face-to-face self-help groups. The proposed study has the following aims:\n\nAim 1: To develop PURPOSE, a social-media based intervention that provides information and coping tools for parents/guardians of adolescent children with a SUD. The theoretically grounded intervention will be peer-led, and will be developed and refined with feedback from experts, providers, parents, and adolescents.\n\nAim 2: To determine the feasibility and acceptability of PURPOSE that uses online peer-led intervention delivery. Trial testing will be conducted to iteratively refine content and procedures in order to optimize the engagement and usefulness of the intervention for parents.\n\nAim 3: To conduct a pilot control trial to provide preliminary data on this intervention so as to determine if social media-based parent support group involvement positively impacts parent outcomes (reduced stigma and distress, improved parent monitoring, and increased engagement in adolescent treatment) and adolescent outcomes (treatment retention and abstinence)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be the parent/guardian of an adolescent (under age 18) currently receiving out-patient treatment for SUD\n* Have an active Facebook and email account\n* Be able to read and write English\n\nExclusion Criteria:\n\n* Any medical and/or psychiatric conditions which would require immediate or ongoing treatment that would make study participation difficult or harmful\n* Already participating in an online support group for parents of teens in treatment'}, 'identificationModule': {'nctId': 'NCT02629068', 'briefTitle': 'PURPOSE: A Social Media Intervention for Parent Support', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Parents United With Responsive Parents for Online Support and Education PURPOSE: A Social Media Intervention for Parent Support', 'orgStudyIdInfo': {'id': 'R21DA039459', 'link': 'https://reporter.nih.gov/quickSearch/R21DA039459', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21DA039459', 'link': 'https://reporter.nih.gov/quickSearch/R21DA039459', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PURPOSE', 'description': 'Parents in the PURPOSE group will join a "secret" Facebook group for 2 months. Groups will be lead by 2 peer leaders and include 20 parent participants.', 'interventionNames': ['Behavioral: PURPOSE']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual (TAU)', 'description': 'Treatment as Usual parents will be contacted after 8 weeks to complete follow-up interview. Will not receive PURPOSE intervention.'}], 'interventions': [{'name': 'PURPOSE', 'type': 'BEHAVIORAL', 'description': 'The first week of the intervention will focus on welcoming everyone to the facebook group and laying down the ground rules for participation. Each additional week of the intervention will focus on a specific topic to promote discussion and learning of each particular skill; however, questions and discussions on other relevant topics are always welcome and encouraged.\n\nWeek 1: Welcome Week Week 2: SUD Basics Week 3: Problem of Stigma Week 4: Communication Skills Week 5: Parental Monitoring Week 6: Stress Management Week 7: Family and Valued Directions Week 8: Putting It All Together', 'armGroupLabels': ['PURPOSE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Integrated Substance Abuse Programs', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Marya Schulte, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Marya Schulte', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}