Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00267605
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2005-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2005-12-19', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.', 'timeFrame': 'baseline, 120, 240 and 365 day follow-up'}], 'secondaryOutcomes': [{'measure': 'Alabama Parenting Questionnaire', 'timeFrame': 'baseline, 120, 240 and 365 day follow-up'}, {'measure': 'Revised Disruptive Disorder Rating Scale', 'timeFrame': 'baseline, 120, 240 and 365 day follow-up'}, {'measure': 'Connors rating scale', 'timeFrame': 'baseline, 120, 240 and 365 day followup'}, {'measure': 'Disability Measure;', 'timeFrame': 'Weekly during treatment; baseline, 120, 240 and 365 day follow-up'}, {'measure': 'Child Health Questionnaire', 'timeFrame': 'baseline, 120, 240 and 365 day follow-up'}, {'measure': 'Economic Outcome assessment', 'timeFrame': 'baseline, 120, 240 and 365 day follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit/Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '17227604', 'type': 'BACKGROUND', 'citation': 'Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.'}, {'pmid': '19270846', 'type': 'BACKGROUND', 'citation': 'McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.'}, {'pmid': '18025870', 'type': 'BACKGROUND', 'citation': "Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25."}, {'pmid': '18632994', 'type': 'BACKGROUND', 'citation': 'Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.'}, {'pmid': '18632997', 'type': 'RESULT', 'citation': 'Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.'}, {'pmid': '22170209', 'type': 'RESULT', 'citation': 'Lingley-Pottie P, Janz T, McGrath PJ, Cunningham C, MacLean C. Outcome progress letter types: parent and physician preferences for letters from pediatric mental health services. Can Fam Physician. 2011 Dec;57(12):e473-81.'}, {'pmid': '22024004', 'type': 'RESULT', 'citation': 'McGrath PJ, Lingley-Pottie P, Thurston C, MacLean C, Cunningham C, Waschbusch DA, Watters C, Stewart S, Bagnell A, Santor D, Chaplin W. Telephone-based mental health interventions for child disruptive behavior or anxiety disorders: randomized trials and overall analysis. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1162-72. doi: 10.1016/j.jaac.2011.07.013. Epub 2011 Sep 3.'}], 'seeAlsoLinks': [{'url': 'http://www.bringinghealthhome.com/', 'label': 'Family Help Program'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate Attention Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.', 'detailedDescription': 'The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 60 children (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity Disorder will be randomized.\n\nThe intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.\n\nFifty percent of the eligible participants will receive Strongest Families (formerly Family Help Program): telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child 3 to 7 years of age\n* child had behavioural problems for 6 months or longer\n* access to a telephone in the home\n* speak and write english\n* mild to moderate attention deficit/hyperactivity symptomology\n\nExclusion Criteria:\n\n* severe attention deficit/hyperactivity symptomology\n* received similar intervention within past 6 months\n* Autism or Schizophrenia\n* child has intellectual impairment'}, 'identificationModule': {'nctId': 'NCT00267605', 'acronym': 'FHPADHD', 'briefTitle': 'Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'IWK Health Centre'}, 'officialTitle': 'Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Attention Deficit/Hyperactivity Disorder)', 'orgStudyIdInfo': {'id': '2234c'}, 'secondaryIdInfos': [{'id': 'CHIR CAHR-43273'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention', 'interventionNames': ['Behavioral: FHPADHD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'ADHD Standard Care 50% randomized to receive standard/usual care for ADHD', 'interventionNames': ['Behavioral: ADHD Standard Care']}], 'interventions': [{'name': 'FHPADHD', 'type': 'BEHAVIORAL', 'otherNames': ['Strongest Families (formerly Family Help Program):'], 'description': 'Evidence-based psychological and behavioural distance intervention', 'armGroupLabels': ['Treatment']}, {'name': 'ADHD Standard Care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Patrick J. McGrath, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IWK Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}