Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT02236650
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2014-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Care Stepping Stones Triple P for Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C472024', 'term': '(tris(diphenylphosphinomethyl)phenylborate)(p-tolylnitrido)iron(I)'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measure conduct problem behavior in children between the ages of 2 and 16 years.'}, {'measure': 'Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'General scale of resilience in adult populations with a bias towards coping with stress and adversity.'}, {'measure': 'Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress:\n\n1. Parental Distress,\n2. Parent-Child Dysfunctional Interaction,\n3. Difficult Child, and\n4. Total Stress.'}, {'measure': 'Change from Baseline in Family Assessment Device score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Assesses family functioning on six different dimensions:\n\n1. Problem Solving (ability to resolve problems),\n2. Communication (exchange of clear and direct verbal information),\n3. Roles (division of responsibility for completing family tasks),\n4. Affective Responsiveness (ability to respond with appropriate emotion),\n5. Affective Involvement (degree to which family members are involved and interested in one another), and\n6. Behavior Control (manner used to express and maintain standards of behavior).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Assesses behavior problems in individuals with developmental disabilities across 5 domains:\n\n1. Irritability and Agitation (15 items)\n2. Lethargy and Social Withdrawal (16 items)\n3. Stereotypic Behavior (7 items)\n4. Hyperactivity and Noncompliance (16 items) and\n5. Inappropriate Speech (4 items).'}, {'measure': 'Change from Baseline in The Parenting Scale Score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measures dysfunctional discipline styles in parents by asking about the probability with which the parent uses particular discipline strategies. It yields four scores:\n\n1. Total score,\n2. Laxness (permissive, inconsistent discipline);\n3. Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and\n4. Verbosity/Hostility (use of verbal or physical force).'}, {'measure': 'Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': "Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parental Resilience', 'Parental Stress', 'Family Adaptation', 'Autistic Disorder', 'Behavior', 'Child Behavior', 'Child Development Disorders', 'Pervasive Developmental Disabilities', 'Caregivers', 'Parents', 'Parenting', 'Primary Health Care'], 'conditions': ['Autism']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Turner K, Markie-Dadds C, Sanders M. Practitioner's manual for primary care tripleP. Brisbane, QLD, Australia: Triple P International Pty. Ltd.; 2010."}, {'type': 'BACKGROUND', 'citation': 'Mazzucchelli T, Sanders M. Stepping Stones Triple P: A Population Approach to the Promotion of Competent Parenting of Children with Disability. Brisbane, Queensland, Australia,: The University of Queensland;2012.'}, {'pmid': '19160053', 'type': 'BACKGROUND', 'citation': 'Prinz RJ, Sanders MR, Shapiro CJ, Whitaker DJ, Lutzker JR. Population-based prevention of child maltreatment: the U.S. Triple p system population trial. Prev Sci. 2009 Mar;10(1):1-12. doi: 10.1007/s11121-009-0123-3.'}, {'type': 'BACKGROUND', 'citation': 'Sanders M, Morawska A. Can changing parental knowledge, dysfunctional expectations and attributions, and emotion regulation improve outcomes for children? In: Tremblay R, Boivin M, Peters R, eds. Encyclopedia on Early Childhood Development [online]. 2nd ed. Montreal, Quebec: Centre of Excellence for Early Childhood Development 2008:1-12.'}, {'pmid': '10965638', 'type': 'BACKGROUND', 'citation': 'Sanders MR, Markie-Dadds C, Tully LA, Bor W. The triple P-positive parenting program: a comparison of enhanced, standard, and self-directed behavioral family intervention for parents of children with early onset conduct problems. J Consult Clin Psychol. 2000 Aug;68(4):624-40.'}, {'type': 'BACKGROUND', 'citation': 'Sanders, Mazzucchelli T, Studman L. Stepping Stones Triple P: The theoretical basis and development of an evidence-based positive parenting program for families with a child who has a disability. Journal of Intellectual & Developmental Disability. 2004 2004;29(3):265-283.'}, {'pmid': '23475006', 'type': 'BACKGROUND', 'citation': 'Tellegen CL, Sanders MR. Stepping Stones Triple P-Positive Parenting Program for children with disability: a systematic review and meta-analysis. Res Dev Disabil. 2013 May;34(5):1556-71. doi: 10.1016/j.ridd.2013.01.022. Epub 2013 Mar 6.'}, {'pmid': '19023654', 'type': 'BACKGROUND', 'citation': 'Whittingham K, Sofronoff K, Sheffield J, Sanders MR. Stepping Stones Triple P: an RCT of a parenting program with parents of a child diagnosed with an autism spectrum disorder. J Abnorm Child Psychol. 2009 May;37(4):469-80. doi: 10.1007/s10802-008-9285-x.'}, {'type': 'BACKGROUND', 'citation': 'Becvar D. Handbook of family resilience. New York, NY: Springer; 2012.'}, {'pmid': '16597214', 'type': 'BACKGROUND', 'citation': 'Roberts C, Mazzucchelli T, Studman L, Sanders MR. Behavioral family intervention for children with developmental disabilities and behavioral problems. J Clin Child Adolesc Psychol. 2006 Jun;35(2):180-93. doi: 10.1207/s15374424jccp3502_2.'}, {'type': 'BACKGROUND', 'citation': 'Eyberg S, Pincus D. Eyberg Child Behavior Inventory and Sutter-Eyberg Student Behaviour Inventory- Revised: Professional manual. Odessa, FL: Psychological Assessment Resources; 1999.'}, {'pmid': '3993694', 'type': 'BACKGROUND', 'citation': 'Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.'}, {'pmid': '18600444', 'type': 'BACKGROUND', 'citation': 'Karabekiroglu K, Aman MG. Validity of the aberrant behavior checklist in a clinical sample of toddlers. Child Psychiatry Hum Dev. 2009 Mar;40(1):99-110. doi: 10.1007/s10578-008-0108-7. Epub 2008 Jul 4.'}, {'type': 'BACKGROUND', 'citation': 'Guy WR, 1976. M. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration; 1976.'}, {'type': 'BACKGROUND', 'citation': "Arnold D, O'Leary S, Wolff S, Acher M. The Parenting Scale: A measure of dysfunctional parenting in discipline situations. Psychological Assessment. 1993 1993;5:137-144."}, {'type': 'BACKGROUND', 'citation': 'Johnston C, Mash E. A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology. 1989 1989;18:167-175.'}, {'pmid': '18157881', 'type': 'BACKGROUND', 'citation': 'Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.'}, {'pmid': '12964174', 'type': 'BACKGROUND', 'citation': 'Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.'}, {'pmid': '11824981', 'type': 'BACKGROUND', 'citation': 'Andrews G, Slade T. Interpreting scores on the Kessler Psychological Distress Scale (K10). Aust N Z J Public Health. 2001 Dec;25(6):494-7. doi: 10.1111/j.1467-842x.2001.tb00310.x.'}, {'pmid': '12578436', 'type': 'BACKGROUND', 'citation': 'Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184.'}, {'type': 'BACKGROUND', 'citation': 'Abidin R. Parent Stress Index-Short Form. Florida: Psychological Assessment Resources Incorporated; 1995.'}, {'pmid': '20546082', 'type': 'BACKGROUND', 'citation': 'Zaidman-Zait A, Mirenda P, Zumbo BD, Wellington S, Dua V, Kalynchuk K. An item response theory analysis of the Parenting Stress Index-Short Form with parents of children with autism spectrum disorders. J Child Psychol Psychiatry. 2010 Nov;51(11):1269-77. doi: 10.1111/j.1469-7610.2010.02266.x.'}, {'pmid': '17372817', 'type': 'BACKGROUND', 'citation': 'Thomas KC, Ellis AR, McLaurin C, Daniels J, Morrissey JP. Access to care for autism-related services. J Autism Dev Disord. 2007 Nov;37(10):1902-12. doi: 10.1007/s10803-006-0323-7. Epub 2007 Mar 19.'}, {'pmid': '14984070', 'type': 'BACKGROUND', 'citation': 'Aitken L, Gallagher R, Madronio C. Principles of recruitment and retention in clinical trials. Int J Nurs Pract. 2003 Dec;9(6):338-46. doi: 10.1046/j.1440-172x.2003.00449.x.'}, {'pmid': '9257072', 'type': 'BACKGROUND', 'citation': 'Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997 Aug;18(4):328-52. doi: 10.1016/s0197-2456(96)00236-x.'}, {'type': 'BACKGROUND', 'citation': 'Meneses K, Roche C. Recruitment and retention in clinical research. 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Prevalence of Autism Spectrum Disorders Autism and Developmental Disabilities Monitoring Network, 14 Sites in the United States. Atlanta, GA: Centers for Disease Control,; 2002.'}, {'pmid': '12503976', 'type': 'BACKGROUND', 'citation': 'Yeargin-Allsopp M, Rice C, Karapurkar T, Doernberg N, Boyle C, Murphy C. Prevalence of autism in a US metropolitan area. JAMA. 2003 Jan 1;289(1):49-55. doi: 10.1001/jama.289.1.49.'}, {'pmid': '12541005', 'type': 'BACKGROUND', 'citation': 'Drew A, Baird G, Baron-Cohen S, Cox A, Slonims V, Wheelwright S, Swettenham J, Berry B, Charman T. A pilot randomised control trial of a parent training intervention for pre-school children with autism. Preliminary findings and methodological challenges. Eur Child Adolesc Psychiatry. 2002 Dec;11(6):266-72. doi: 10.1007/s00787-002-0299-6.'}, {'pmid': '20102651', 'type': 'BACKGROUND', 'citation': 'Blandon AY, Calkins SD, Keane SP. Predicting emotional and social competence during early childhood from toddler risk and maternal behavior. Dev Psychopathol. 2010 Winter;22(1):119-32. doi: 10.1017/S0954579409990307.'}, {'pmid': '17286734', 'type': 'BACKGROUND', 'citation': 'McConachie H, Diggle T. Parent implemented early intervention for young children with autism spectrum disorder: a systematic review. J Eval Clin Pract. 2007 Feb;13(1):120-9. doi: 10.1111/j.1365-2753.2006.00674.x.'}, {'pmid': '20440639', 'type': 'BACKGROUND', 'citation': 'Oosterling I, Visser J, Swinkels S, Rommelse N, Donders R, Woudenberg T, Roos S, van der Gaag RJ, Buitelaar J. Randomized controlled trial of the focus parent training for toddlers with autism: 1-year outcome. J Autism Dev Disord. 2010 Dec;40(12):1447-58. doi: 10.1007/s10803-010-1004-0.'}, {'pmid': '11433077', 'type': 'BACKGROUND', 'citation': 'Developmental surveillance and screening of infants and young children. Pediatrics. 2001 Jul;108(1):192-6. doi: 10.1542/peds.108.1.192.'}], 'seeAlsoLinks': [{'url': 'https://sites.google.com/a/slu.edu/debra-h-zand-ph-d/parent-child-intervention-research-team-p-chirt', 'label': 'Family Research Collaborative - Autism \\& Parenting Resilience'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease parental stress.', 'detailedDescription': "Research literature exists on best practices for screening and diagnosing children with Autism. However, less is known about how to intervene with the child's parent. Across studies, relative to parents of children without disabilities, parents of children with Autism have reported higher levels of stress and lower levels of parenting competence. Such stress places children at risk for adverse developmental outcomes\n\nThe proposed study aims to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease parental stress.\n\nThe specific hypotheses include:\n\n1. Children whose parents receive PC-SS Triple P will demonstrate significantly greater improvements in their behavioral functioning than children of parents receiving Wait-list Control (WLC) at service closure.\n2. At service closure, parents receiving the PC-SS Triple P intervention will be more resilient and demonstrate lower levels of stress than parents in the Wait-List Control (WLC) condition.\n3. Parenting resilience and levels of parental stress will be positively associated with improvements in child behavior.\n\nSeventy-six parents of children newly diagnosed with Autism will be randomized into one of two conditions: a) PC-SS Triple P (N=38) or b) Wait List Control (WLC; N=38). Study data will be collected with the assistance of a data collector appropriately trained in human subject rights protections.\n\nIt is anticipated that the present project will assist in the development and use of evidence-based practices for working with parents of children newly diagnosed with Autism within pediatric settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParent inclusion criteria:\n\n* being at least 18 years of age\n\nIndex child inclusion criteria:\n\n* receives a Diagnostic and Statistical Manual V (DSM-V) diagnosis of Autism with mild or moderate severity within 12 months of study onset.\n* age is \\> or equal to 24 months (2 years, 0 months) and \\< or equal to 155 months old (12 years, 11 months).\n\nExclusion Criteria:\n\nParent exclusion criteria:\n\n* inability to provide informed consent.\n* being non-English speaking.\n\nIndex child exclusion criteria:\n\n* being a ward of the State of Missouri.\n* being a sibling of another study participant.'}, 'identificationModule': {'nctId': 'NCT02236650', 'briefTitle': 'Primary Care Stepping Stones Triple P for Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism', 'orgStudyIdInfo': {'id': 'SLUBM_24272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary Care Stepping Stones Triple P', 'description': 'Primary Care Stepping Stones Triple P program (PC-SS Triple P) - a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.', 'interventionNames': ['Behavioral: Primary Care Stepping Stones Triple P (PC-SS Triple P)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wait List Control (WLC)', 'description': 'Wait List Control - Participants who will have access to treatment as usual services during the 4 weeks between baseline and 4 week assessment time points and then will have the opportunity to receive PC-SS Triple P.', 'interventionNames': ['Other: Treatment as Usual']}], 'interventions': [{'name': 'Primary Care Stepping Stones Triple P (PC-SS Triple P)', 'type': 'BEHAVIORAL', 'otherNames': ['Postive Parenting Program', 'Triple P', 'Stepping Stones Triple P', 'Stepping Stones Positive Parenting Program'], 'description': 'PC-SS Triple P is a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.', 'armGroupLabels': ['Primary Care Stepping Stones Triple P']}, {'name': 'Treatment as Usual', 'type': 'OTHER', 'otherNames': ['Service as Usual'], 'description': 'Treatment as Usual for 4 weeks', 'armGroupLabels': ['Wait List Control (WLC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University, Knights of Columbus Developmental Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Debra H. Zand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Debra H. Zand, Ph.D.', 'investigatorAffiliation': 'St. Louis University'}}}}