Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-28 @ 3:12 AM
Study NCT ID:
NCT00267618
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2005-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2005-12-19', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', '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': 'Symptomology frequency as evidenced by diary data;', 'timeFrame': 'daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization'}, {'measure': 'Evaluated according to IHS criteria', 'timeFrame': 'baseline, 120, 240 and 365 day follow-up'}, {'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'}, {'measure': 'Satisfaction measure, designed by the investigator', 'timeFrame': 'end of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pediatric Recurrent Headache & Abdominal Pain']}, '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': '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': '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': '18632997', 'type': 'BACKGROUND', '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.'}], '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 Recurrent Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.', 'detailedDescription': 'The purpose of the 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 106 children (9-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Recurrent Headache/Abdominal Pain 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 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 Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* child 9 to 16 years of age\n* child had recurrent headache and abdominal pain at least 3 times a month\n* child's physical examination normal\n* access to a telephone in the home\n* speak and write english\n* mild to moderate anxiety symptomology\n\nExclusion Criteria:\n\n* child's pain due to trauma, systemic disease or disorder\n* child received any psychological treatment for this or similar disorder in the past 6 months"}, 'identificationModule': {'nctId': 'NCT00267618', 'briefTitle': 'Family Help Program: Pediatric Recurrent Headache and Abdominal Pain', 'organization': {'class': 'OTHER', 'fullName': 'IWK Health Centre'}, 'officialTitle': 'Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)', 'orgStudyIdInfo': {'id': '2234d'}, 'secondaryIdInfos': [{'id': 'CHIR CAHR-43273'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '50% randomized to receive FHP Pain intervention', 'interventionNames': ['Behavioral: FHP Pain']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': '50% randomized to receive standard/usual care for recurrent headache/abdominal pain'}], 'interventions': [{'name': 'FHP Pain', 'type': 'BEHAVIORAL', 'description': 'Evidence-based psychological and behavioural Intervention', 'armGroupLabels': ['Treatment']}]}, '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'}}}}