Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
Study NCT ID:
NCT03921892
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2019-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Parenting Education Approaches for Adolescent Fathers
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': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Using a block randomization generator, participants will be randomized into either in-person or on-line parenting education that will take place over a two week period of time.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2019-04-14', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Measure 1', 'timeFrame': '12 months', 'description': 'Did recruitment numbers meet goals'}, {'measure': 'Feasibility Measure 2', 'timeFrame': '12 months', 'description': 'Attrition rate of participants'}, {'measure': 'Feasibility Measure 3', 'timeFrame': '12 months', 'description': 'Percent of data missing from data collection tools'}, {'measure': 'Acceptability Survey Measure 1 (Likert Scale)', 'timeFrame': '12 months', 'description': 'Acceptability of learning content to participants'}, {'measure': 'Acceptability Survey Measure 2 (Likert Scale)', 'timeFrame': '12 months', 'description': 'Acceptability of time burden to participants'}, {'measure': 'Acceptability Survey Measure 3 (Likert Scale)', 'timeFrame': '12 months', 'description': 'Acceptability of learning method to participants'}], 'secondaryOutcomes': [{'measure': 'What is the difference between in-person education as compared to on-line parenting education on parental self-efficacy of adolescent fathers as measured by the Parenting Sense of Competence Scale (PSOC)?', 'timeFrame': '12 months', 'description': 'Does providing parenting education to adolescent fathers, either in-person or on-line, change their levels of parenting self-efficacy'}, {'measure': 'What is the difference between in-person parenting education as compared to on-line parenting education on participation in parenting activities of adolescent fathers as measured by the Child Care Activities Scale (CCAS)?', 'timeFrame': '12 months', 'description': 'Does either in-person or on-line parenting education impact the participation in parenting activities of adolescent fathers?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent, Parenting']}, 'referencesModule': {'references': [{'pmid': '19857857', 'type': 'BACKGROUND', 'citation': 'Savio Beers LA, Hollo RE. Approaching the adolescent-headed family: a review of teen parenting. Curr Probl Pediatr Adolesc Health Care. 2009 Oct;39(9):216-33. doi: 10.1016/j.cppeds.2009.09.001.'}, {'type': 'BACKGROUND', 'citation': 'Kiselica, M. S., & Kiselica, A. M. (2014). The complicated worlds of adolescent fathers: Implications for clinical practice, public policy, and research. Psychology of Men & Masculinity, 15(3), 260-274. doi:10.1037/a0037043'}, {'pmid': '19645829', 'type': 'BACKGROUND', 'citation': 'Sevigny PR, Loutzenhiser L. Predictors of parenting self-efficacy in mothers and fathers of toddlers. Child Care Health Dev. 2010 Mar;36(2):179-89. doi: 10.1111/j.1365-2214.2009.00980.x. Epub 2009 Jul 23.'}, {'type': 'BACKGROUND', 'citation': "Seymour, M., Dunning, M., Cooklin, A., & Giallo, R. (2014). Socioecological factors associated with fathers' well-being difficulties in the early parenting period. Clinical Psychologist, 18(2), 63-73. doi:10.1111/cp.12016"}, {'pmid': '21645156', 'type': 'BACKGROUND', 'citation': "Wilkes L, Mannix J, Jackson D. 'I am going to be a dad': experiences and expectations of adolescent and young adult expectant fathers. J Clin Nurs. 2012 Jan;21(1-2):180-8. doi: 10.1111/j.1365-2702.2011.03715.x. Epub 2011 Jun 5."}, {'pmid': '27183189', 'type': 'BACKGROUND', 'citation': "Rominov H, Giallo R, Whelan TA. Fathers' postnatal distress, parenting self-efficacy, later parenting behavior, and children's emotional-behavioral functioning: A longitudinal study. J Fam Psychol. 2016 Dec;30(8):907-917. doi: 10.1037/fam0000216. Epub 2016 May 16."}, {'pmid': '26880281', 'type': 'BACKGROUND', 'citation': 'Love SM, Sanders MR, Turner KM, Maurange M, Knott T, Prinz R, Metzler C, Ainsworth AT. Social media and gamification: Engaging vulnerable parents in an online evidence-based parenting program. Child Abuse Negl. 2016 Mar;53:95-107. doi: 10.1016/j.chiabu.2015.10.031. Epub 2016 Feb 12.'}, {'pmid': '27773964', 'type': 'BACKGROUND', 'citation': 'Hall CM, Bierman KL. Technology-assisted Interventions for Parents of Young Children: Emerging Practices, Current Research, and Future Directions. Early Child Res Q. 2015 4th Quarter;33:21-32. doi: 10.1016/j.ecresq.2015.05.003. Epub 2015 May 23.'}, {'type': 'BACKGROUND', 'citation': "Fagan, J., Bernd, E., & Whiteman, V. (2007). Adolescent fathers' parenting stress, social support, and involvement with infants. Journal of Research on Adolescence, 17(1), 1-22. doi:10.1111/j.1532-7795.2007.00510.x"}, {'pmid': '3175054', 'type': 'RESULT', 'citation': 'Cronenwett LR, Sampselle CM, Wilson WR. The Child Care Activities Scale and Parental Role Preference Scale. Res Nurs Health. 1988 Oct;11(5):301-8. doi: 10.1002/nur.4770110505.'}, {'type': 'RESULT', 'citation': 'Johnston, C., & Mash, E. J., (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175'}]}, 'descriptionModule': {'briefSummary': 'This feasibility and acceptability study will compare in-person to web-based parenting education for adolescent fathers on the outcomes of parenting confidence and participation in parenting activities.', 'detailedDescription': "This is a randomized feasibility and acceptability study using a block generator for randomization of participants aged 15 to 21 into either in-person parenting education or on-line parenting. Outcome measures include parenting self-efficacy and participation in daily parenting activities. Participants will take part in approximately twelve hours of parenting education, whether in-person or on-line. Recruitment flyers will be placed in two primary care clinics and a large regional hospital's Labor \\& Delivery and Postpartum (Mother-Baby) Units. Participants will seek out the opportunity to participate by calling the phone number or sending an e-mail to the investigators to learn more about the study and their potential participation. If participants meet eligibility criteria and elect to participate, baseline measurements will be completed after enrollment, with follow-up measures at one month and two months."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Adolescent males aged 15 to 21', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 15 to 21,\n* be able to read and understand English (as determined by having the individual read a brief, eighth grade reading level paragraph),\n* able to begin the intervention within six weeks of their infant's birth,\n* be able to participate in an intervention over two weeks, requiring approximately a 12-hour time commitment: either in-person on two Saturdays for six hours each, or a self-paced content of videos and resource materials over two weeks,\n* own or have access to a device with internet access and\n* have a working e-mail address.\n\nExclusion Criteria:\n\n* Any condition that might prevent the father's infant from reaching normal developmental milestones will participation, including congenital malformations or prematurity requiring prolonged/ ongoing infant hospitalization."}, 'identificationModule': {'nctId': 'NCT03921892', 'briefTitle': 'A Comparison of Parenting Education Approaches for Adolescent Fathers', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, Kansas City'}, 'officialTitle': 'A Randomized Feasibility and Acceptability Study Comparing In-person to On-line Parenting Education for Adolescent Fathers', 'orgStudyIdInfo': {'id': '2019000019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'In-person parenting education', 'description': 'Participants will complete two six-hour in-person parenting education sessions on two consecutive Saturdays', 'interventionNames': ['Behavioral: Parenting Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On-line parenting education', 'description': 'Participants will complete on-line parenting education at the times and locations of their choice over a two-week period.', 'interventionNames': ['Behavioral: Parenting Education']}], 'interventions': [{'name': 'Parenting Education', 'type': 'BEHAVIORAL', 'description': 'Parenting education such as positive parenting interactions with their child, knowledge of developmental milestones and interactions with the child to support that development, as well as co-parenting skills will be provided either in-person or on-line to adolescent fathers', 'armGroupLabels': ['In-person parenting education', 'On-line parenting education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99503', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Anchorage Neighborhood Health Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Family Medicine Clinic', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rita Sue Lasiter', 'investigatorAffiliation': 'University of Missouri, Kansas City'}}}}