Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT03495635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-19
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Big Brothers Big Sisters Mentoring for Prevention of Crime and Delinquency
Sponsor:
Organization:
Raw JSON
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Juvenile justice authorities providing arrest record information will be masked to study arm of participants as will all those on the research team who are involved in coding this information.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Enrolled participants will be assigned randomly to participate in the Big Brothers Big Sisters Community-Based Mentoring Program (treatment group) or to a wait-list control group that is not eligible to participate in the program for a period of 4 years.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1361}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrest', 'timeFrame': '4 years', 'description': '0/1 indicator based on official police/court/juvenile office records of any of the following types of offenses-person offense, property offense, drug law violation, public order offense, or status offense'}, {'measure': 'Arrest', 'timeFrame': '18 months', 'description': '0/1 indicator based on official police/court/juvenile office records of any of the following types of offenses-person offense, property offense, drug law violation, public order offense, or status offense'}, {'measure': 'Delinquency', 'timeFrame': '18 months', 'description': '0/1 indicator based on youth and parent report using 13 items from the Add Health Study (Bearman et al., 1997)'}, {'measure': 'Substance use', 'timeFrame': '18 months', 'description': '0/1 indicator based on youth report of alcohol use to point of drunkenness, tobacco, or illicit drug use'}], 'secondaryOutcomes': [{'measure': 'Truancy', 'timeFrame': '18 months', 'description': '3-item youth-report measure (2 items from Herrera et al., 2013)'}, {'measure': 'Association with deviant peers', 'timeFrame': '18 months', 'description': 'A single measure computed as the average of scores on continuous youth-report measure (Elliott et al., 1996) and one-item (0/1) parent-report indicator from Youth Risk Index (Herrera et al., 2013) after each score has been standardized to mean of 0 and standard deviation of 1.'}, {'measure': 'School suspensions', 'timeFrame': '18 months', 'description': 'One-item (0/1) parent-report indicator from Youth Risk Index (Herrera et al., 2013)'}, {'measure': 'Depressive symptoms', 'timeFrame': '18 months', 'description': 'Depressive Symptoms Pediatric Self-Report - Short Form from the Patient-Reported Outcomes Measurement Information System (PROMIS) (Irwin et al., 2010). Lower scores indicate a better outcome'}, {'measure': 'Impulsivity', 'timeFrame': '18 months', 'description': 'A single measure computed as the average of scores on continuous youth- and parent-report scales (Hay \\& Meldrum, 2010) after each score has been standardized to mean of 0 and standard deviation of 1.'}, {'measure': 'Conventional values', 'timeFrame': '18 months', 'description': 'Belief in the Moral Order scale of the Communities That Care Youth Survey (Arthur et al., 2002)'}, {'measure': 'Aggressive behavior', 'timeFrame': '18 months', 'description': "A single measure computed as the average of scores on youth-report Aggression Scale (Orpinas \\& Frankowski, 2001) and parent-report Parent's Checklist from the Fast Track Project: https://fasttrackproject.org/techrept/p/pcl/ after each score has been standardized to mean of 0 and standard deviation of 1."}, {'measure': 'Academic success', 'timeFrame': '18 months', 'description': '4-item measure of grades in core subjects (Herrera et al., 2013)'}, {'measure': 'Positive parenting', 'timeFrame': '18 months', 'description': 'Parent-report Positive Parenting subscale from the Alabama Parenting Questionnaire (Essau et al., 2006)'}, {'measure': 'Parent involvement', 'timeFrame': '18 months', 'description': 'Parent-report Involvement subscale from the Alabama Parenting Questionnaire (Essau et al., 2006)'}, {'measure': 'Parental monitoring and supervision', 'timeFrame': '18 months', 'description': 'Parent-report Poor Monitoring/Supervision subscale from the Alabama Parenting Questionnaire (Essau et al., 2006)'}, {'measure': 'Parental consistent discipline', 'timeFrame': '18 months', 'description': 'Parent-report Inconsistent Discipline subscale from the Alabama Parenting Questionnaire (Essau et al., 2006)'}, {'measure': 'Family relationships', 'timeFrame': '18 months', 'description': 'Parent-report General Functioning scale of the Family Assessment Device (Epstein et al., 1983)'}, {'measure': 'Perceived social support from family members', 'timeFrame': '18 months', 'description': 'Youth-report Multidimensional Scale of Perceived Social Support (Zimet et al., 1988): Family Members subscale'}, {'measure': 'Perceived social support from peers', 'timeFrame': '18 months', 'description': 'Youth-report Multidimensional Scale of Perceived Social Support (Zimet et al., 1988): Peers subscale'}, {'measure': 'Perceived social support from special person', 'timeFrame': '18 months', 'description': 'Youth-report Multidimensional Scale of Perceived Social Support (Zimet et al., 1988): Significant Others subscale'}, {'measure': 'School engagement', 'timeFrame': '18 months', 'description': 'Youth-report Behavioral Engagement subscale of the Engagement versus Disaffection with Learning Scale (Skinner et al., 2009)'}, {'measure': 'Goal-setting and pursuit', 'timeFrame': '18 months', 'description': 'Parent-report Goal Orientation scale from Child Trends: https://www.childtrends.org/research/research-by-topic/positive-indicators-project/goal-orientation/'}, {'measure': 'Involvement in out-of-school-time activities', 'timeFrame': '18 months', 'description': 'Parent-report (Herrera et al., 2007)'}, {'measure': 'Volunteering in the community', 'timeFrame': '18 months', 'description': 'Youth-report single-item (Herrera et al., 2013)'}, {'measure': 'Life satisfaction', 'timeFrame': '18 months', 'description': "Youth-report single-item measure from WHO's 2005-06 Health Behaviors in School Age Children Survey: http://filer.uib.no/psyfa/HEMIL-senteret/HBSC/2006\\_Mandatory\\_Questionnaire.pdf"}, {'measure': 'Self-esteem', 'timeFrame': '18 months', 'description': 'Youth-report Global Self-Esteem subscale of brief version of the Self-Esteem Questionnaire (DuBois et al., 1996; Silverthorn et al., 2017)'}, {'measure': 'Happiness', 'timeFrame': '18 months', 'description': 'Youth-report Positive Affect Pediatric Self-Report - Short Form from the Patient-Reported Outcomes Measurement Information System (PROMIS) (Forrest et al., 2017)'}, {'measure': 'Grit', 'timeFrame': '18 months', 'description': 'Youth-report Grit Scale for Children (Duckworth \\& Quinn, 2009)'}, {'measure': 'Social competence', 'timeFrame': '18 months', 'description': 'Social Competencies Scale of the Youth Outcome Measures Online Toolbox (Muris, 2001)'}, {'measure': 'Special interest development', 'timeFrame': '18 months', 'description': 'Youth-report (adapted from DuBois \\& Keller, 2017)'}, {'measure': 'Hopeful future expectations', 'timeFrame': '18 months', 'description': 'Youth-report abbreviated version of the Hopeful Future Expectations Scale (Bowers et al., 2012)'}, {'measure': 'Career exploration', 'timeFrame': '18 months', 'description': 'Youth-report 2 items (adapted from Herrera et al., 2011)'}, {'measure': 'College exploration', 'timeFrame': '18 months', 'description': 'Youth-report 1 item (adapted from Herrera et al., 2011)'}, {'measure': 'Self-advocacy', 'timeFrame': '18 months', 'description': 'Youth-report (Jarjoura et al., 2017)'}, {'measure': 'Coping efficacy', 'timeFrame': '18 months', 'description': 'Youth-report 1 item adapted from Coping Efficacy Scale (Sandler et al., 2000)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mentoring', 'prevention'], 'conditions': ['Crime', 'Juvenile Delinquency']}, 'referencesModule': {'availIpds': [{'id': 'osf.io/8ukfv', 'url': 'https://osf.io/', 'type': 'Individual Participant Data Set'}], 'references': [{'pmid': '12465571', 'type': 'BACKGROUND', 'citation': 'Arthur MW, Hawkins JD, Pollard JA, Catalano RF, Baglioni AJ Jr. Measuring risk and protective factors for substance use, delinquency, and other adolescent problem behaviors. The Communities That Care Youth Survey. Eval Rev. 2002 Dec;26(6):575-601. doi: 10.1177/0193841X0202600601.'}, {'pmid': '9293990', 'type': 'BACKGROUND', 'citation': 'Resnick MD, Bearman PS, Blum RW, Bauman KE, Harris KM, Jones J, Tabor J, Beuhring T, Sieving RE, Shew M, Ireland M, Bearinger LH, Udry JR. Protecting adolescents from harm. Findings from the National Longitudinal Study on Adolescent Health. JAMA. 1997 Sep 10;278(10):823-32. doi: 10.1001/jama.278.10.823.'}, {'type': 'BACKGROUND', 'citation': 'Bowers, E. P., Geldhof, G. J., Schmid, K. L., Napolitano, C. M., Minor, K., & Lerner, J. V. (2012). Relationships with important nonparental adults and positive youth development: An examination of youth self-regulatory strengths as mediators. Research in Human Development, 9, 298-316. http://dx.doi.org/10.1080/15427609.2012.729911'}, {'type': 'BACKGROUND', 'citation': 'DuBois, D. L., Felner, R. D., Brand, S., Phillips, R. S. C., & Lease, A. M. (1996). Early adolescent self-esteem: A developmental-ecological framework and assessment strategy. Journal of Research on Adolescence, 6, 543-579.'}, {'pmid': '28626886', 'type': 'BACKGROUND', 'citation': 'DuBois DL, Keller TE. Investigation of the Integration of Supports for Youth Thriving Into a Community-Based Mentoring Program. Child Dev. 2017 Sep;88(5):1480-1491. doi: 10.1111/cdev.12887. Epub 2017 Jun 19.'}, {'pmid': '19205937', 'type': 'BACKGROUND', 'citation': 'Duckworth AL, Quinn PD. Development and validation of the short grit scale (grit-s). J Pers Assess. 2009 Mar;91(2):166-74. doi: 10.1080/00223890802634290.'}, {'type': 'BACKGROUND', 'citation': 'Essau, C. A., Sasagawa, S., & Frick, P. J. (2006). Psychometric properties of the Alabama Parenting Questionnaire. Journal of Child and Family Studies, 15, 597-616.'}, {'type': 'BACKGROUND', 'citation': 'Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster Family Assessment Device. Journal of Marital and Family Therapy, 9, 171-180.'}, {'pmid': '21291446', 'type': 'BACKGROUND', 'citation': 'Herrera C, Grossman JB, Kauh TJ, McMaken J. Mentoring in schools: an impact study of big brothers big sisters school-based mentoring. Child Dev. 2011 Jan-Feb;82(1):346-61. doi: 10.1111/j.1467-8624.2010.01559.x.'}, {'type': 'BACKGROUND', 'citation': "Herrera, C., Linden, L. L., Arbreton, J. A. & Grossman, J. B. (2011). Testing the impact of Higher Achievement's year-round out-of-school-time program on academic outcomes. Philadelphia: Public/Private Ventures."}, {'pmid': '20213516', 'type': 'BACKGROUND', 'citation': 'Irwin DE, Stucky B, Langer MM, Thissen D, Dewitt EM, Lai JS, Varni JW, Yeatts K, DeWalt DA. An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Qual Life Res. 2010 May;19(4):595-607. doi: 10.1007/s11136-010-9619-3. Epub 2010 Mar 7.'}, {'type': 'BACKGROUND', 'citation': 'Jarjoura, G. R. et al. (2017). The Evaluation of The Mentoring Enhancement Demonstration Program. Washington, DC: American Institutes for Research. Manuscript in preparation.'}, {'type': 'BACKGROUND', 'citation': 'Muris, P. (2001). A brief questionnaire for measuring self-efficacy in youths. Journal of Psychopathology and Behavioral Assessment, 23, 145-149. http://dx.doi.org/10.1023/A:1010961119608'}, {'type': 'BACKGROUND', 'citation': 'Orpinas P, & Frankowski R. (2001). The aggression scale: a self-report measure of aggressive behavior for young adolescents. Journal of Early Adolescence, 21, 51-68.'}, {'pmid': '11016569', 'type': 'BACKGROUND', 'citation': 'Sandler IN, Tein JY, Mehta P, Wolchik S, Ayers T. Coping efficacy and psychological problems of children of divorce. Child Dev. 2000 Jul-Aug;71(4):1099-118. doi: 10.1111/1467-8624.00212.'}, {'pmid': '26781590', 'type': 'BACKGROUND', 'citation': 'Bavarian N, Lewis KM, Acock A, DuBois DL, Yan Z, Vuchinich S, Silverthorn N, Day J, Flay BR. Effects of a School-Based Social-Emotional and Character Development Program on Health Behaviors: A Matched-Pair, Cluster-Randomized Controlled Trial. J Prim Prev. 2016 Feb;37(1):87-105. doi: 10.1007/s10935-016-0417-8.'}, {'type': 'BACKGROUND', 'citation': "Skinner, E. A., Kindermann, T. A., & Furrer, C. J. (2009). A motivational perspective on engagement and disaffection: Conceptualization and assessment of children's behavioral and emotional participation in academic activities in the classroom. Educational and Psychological Measurement, 69, 493-525. http://dx.doi.org/10.1177/0013164408323233"}, {'type': 'BACKGROUND', 'citation': 'Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52, 30-41. http://dx.doi.org/10.1207/s15327752jpa5201_2'}, {'type': 'BACKGROUND', 'citation': 'Elliott, D. S., Wilson, W. J., Huizinga, D., Sampson, R. J., Elliott, A., & Rankin, B. (1996). The effects of neighborhood disadvantage on adolescent development. Journal of Research in Crime and Delinquency, 33, 389. doi:10.1177=0022427896033004002'}, {'pmid': '29760578', 'type': 'BACKGROUND', 'citation': 'Forrest CB, Ravens-Sieberer U, Devine J, Becker BD, Teneralli R, Moon J, Carle A, Tucker CA, Bevans KB. Development and Evaluation of the PROMIS(R) Pediatric Positive Affect Item Bank, Child-Report and Parent-Proxy Editions. J Happiness Stud. 2018 Mar;19(3):699-718. doi: 10.1007/s10902-016-9843-9. Epub 2017 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of the Big Brothers Big Sisters of America (BBBSA) community-based mentoring (CBM) program for prevention of crime and delinquency/conduct problems, including risk and protective factors for these outcomes. Approximately 2,500 youth ages 10-16 will be randomly assigned to either the CBM program or an untreated control group. Study outcomes will be assessed over a 4-year period via both youth- and parent-report surveys and official records of police/court contact (e.g., arrests).', 'detailedDescription': "The purpose of this study is to evaluate the effectiveness of the Big Brothers Big Sisters of America (BBBSA) community-based mentoring (CBM) program for prevention of crime and delinquency/conduct problems, including risk and protective factors for these outcomes. Participants will be recruited from 16 BBBSA affiliates, which are located in different regions of the U.S. and were invited to serve as sites for the study using a random selection process. The study sample will consist of approximately 2,500 youth ages 10-16 whose parents seek services from one of the participating BBBSA affiliates during the study enrollment period and for whom consent/assent to participate in the research is obtained. Enrolled youth will be randomly assigned to participate in the CBM program (treatment group) or to a control group (no BBBSA programming during the youth's 4-year period of study participation). Youth will be assigned in a 3:1 ratio to the treatment and control groups. Youth and parents will complete survey measures both at study enrollment, prior to notification of assignment to control or treatment group, and 18 months later. Official records of police/court contact (e.g., arrests), with separate parent/guardian consent as provided at study enrollment, will be obtained both for the period preceding each youth's enrollment in the study and for a 4-year period following enrollment.\n\nThe study has 4 specific aims:\n\n1. To determine the effects of participation in the Big Brothers Big Sisters CBM program on youth offending as measured by police/court records, i.e., person offense, property offense, drug law violation, public order offense, or status offense.\n2. To determine the effects of participation in the BBBS CBM program on the likelihood of youths' involvement in delinquent behavior/conduct problems as assessed by youth and parent reports.\n3. To determine the effects of BBBS CBM program participation on the likelihood of youths' involvement in substance use as assessed by self-reports of alcohol use to point of drunkenness, tobacco, or illicit drug use.\n4. To determine the effects of BBBS CBM program participation on both risk and protective factors for delinquent/criminal behavior, such as aggression, depressive symptoms, association with deviant peers, self-control, and school connectedness, as assessed by youth and/or parent reports, and to explore the role of these effects in mediating effects of program participation on offending, delinquent behavior, and substance use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* youth is 10 years of age or older\n* youth is likely to be eligible for the Big Brothers Big Sisters Community-Based Mentoring program as determined by initial assessment of program staff\n\nExclusion criteria:\n\n* youth has a severe learning, cognitive or other intellectual disability as reported by the parent\n* parent does not both speak and read either English or Spanish\n* youth does not have a sibling who is already a study participant\n* youth has been matched with a Big Brother/Sister through one of the affiliate's programs in the past\n* youth has a sibling currently receiving services from the affiliate for whom services were initiated (i.e., inquiry was made) prior to start of the study\n* youth belongs to a group that the affiliate is excluding from study participation based on previous agreement with the research team\n* youth is designated as an exception case by affiliate staff (each affiliate will have the opportunity to exclude up to 4% of study-eligible youth from the research prior to consent and random assignment for any reason deemed appropriate (e.g., perceived high need of the youth))"}, 'identificationModule': {'nctId': 'NCT03495635', 'briefTitle': 'Randomized Controlled Trial of Big Brothers Big Sisters Mentoring for Prevention of Crime and Delinquency', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Randomized Controlled Trial of the Big Brothers Big Sisters Community-Based Mentoring Program for Prevention of Crime and Juvenile Delinquency', 'orgStudyIdInfo': {'id': '2017-0291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BBBS Community-Based Mentoring', 'description': 'Big Brothers Big Sisters Community-Based Mentoring Program', 'interventionNames': ['Behavioral: Big Brothers Big Sisters Community-Based Mentoring Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Not eligible to participate in a Big Brothers Big Sisters mentoring program, but may participate in other mentoring programs.'}], 'interventions': [{'name': 'Big Brothers Big Sisters Community-Based Mentoring Program', 'type': 'BEHAVIORAL', 'description': 'One-to-one mentoring provided by an adult volunteer with training and ongoing monitoring and support from program staff.', 'armGroupLabels': ['BBBS Community-Based Mentoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David L DuBois, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}, {'name': 'Carla Herrera, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herrera Consulting Group, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/8ukfv/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available August 2024 and will be permanently available thereafter', 'ipdSharing': 'YES', 'description': "At the study's conclusion, all individual participant data will be de-identified and made publicly available on the Open Science Framework website along with survey instruments and any code used to clean and analyze the data.", 'accessCriteria': "Requests to access the IPD will be made in writing to the Principal Investigator and approved so long as there is a valid scientific rationale and appropriate IRB approval. The mechanism for sharing the data, all of which will be de-identified, will be secure and encrypted FTP and subject to approval of the PI's institutional IRB. Supporting information (see above list) will be available on the Open Science Framework at the web address below."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laura and John Arnold Foundation', 'class': 'OTHER'}, {'name': 'Herrera Consulting Group, LLC', 'class': 'UNKNOWN'}, {'name': 'Big Brothers Big Sisters of America', 'class': 'UNKNOWN'}, {'name': 'National Council of Juvenile and Family Court Judges', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Community Health Sciences', 'investigatorFullName': 'David DuBois', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}