Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 12:53 PM
Study NCT ID:
NCT00055068
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2003-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2003-02-19', 'studyFirstSubmitQcDate': '2003-02-19', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '18356758', 'type': 'DERIVED', 'citation': 'Freeman JB, Garcia AM, Coyne L, Ale C, Przeworski A, Himle M, Compton S, Leonard HL. Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. J Am Acad Child Adolesc Psychiatry. 2008 May;47(5):593-602. doi: 10.1097/CHI.0b013e31816765f9.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate a treatment program for young children with Obsessive Compulsive Disorder (OCD) and their families.', 'detailedDescription': 'Childhood onset OCD is a serious condition that may be a predictor of illness in adulthood. To date, no OCD psychotherapy trials have specifically focused on early childhood. Development of interventions for childhood onset OCD that address both developmental considerations and familial relationships is necessary.\n\nParticipants are randomly assigned to receive 12 sessions of either Cognitive Behavioral Therapy (CBT) or Relaxation Training (RT) over the course of 14 weeks. The CBT treatment is designed to lessen anxiety by addressing specific OCD symptoms. The relaxation intervention addresses generalized feelings of anxiety with the expectation that OCD symptoms may benefit indirectly. The clarity, completeness, acceptability, and feasibility of both interventions is assessed. A 3-month post-treatment follow-up is also conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obsessive Compulsive Disorder (OCD)'}, 'identificationModule': {'nctId': 'NCT00055068', 'briefTitle': 'Family Based Treatment of Early Childhood Obsessive Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Family Based Treatment of Early Childhood OCD', 'orgStudyIdInfo': {'id': 'R21MH060669', 'link': 'https://reporter.nih.gov/quickSearch/R21MH060669', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21MH060669', 'link': 'https://reporter.nih.gov/quickSearch/R21MH060669', 'type': 'NIH'}, {'id': 'DSIR CT-S'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL'}, {'name': 'Relaxation Training', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital/Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}]}}}