Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-08 @ 5:17 PM
Study NCT ID:
NCT00625261
Status:
UNKNOWN
Last Update Posted:
2008-02-28
First Post:
2008-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Early Parent-Based Language Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007805', 'term': 'Language Development Disorders'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D007806', 'term': 'Language Disorders'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-02-19', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Receptive and expressive language abilities using standardized instruments (SETK-2, SETK 3-5, AWST, HVS, HASE, HSET)', 'timeFrame': 'at 2; 6, 3, 4, 5 and 8 years of age'}], 'secondaryOutcomes': [{'measure': 'Parent-report screening questionnaire ELFRA-2 (adoption of the MacArthur Communicative Development Inventories-CDI); cognitive and social-emotional development assessed by standardized instruments,', 'timeFrame': 'at 2;6, 3, 4, 5 and 8 years of age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Language delay', 'Speech and language disorders', 'Early language intervention', 'Parent-based language intervention'], 'conditions': ['Language Delay', 'Developmental Language Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effectiveness of a highly-structured parent-based language intervention group program for two-year-old children with language delay.', 'detailedDescription': 'Language delay in toddlers is a prevalent problem for pediatric practitioners. As there are no clear guidelines to deal with this problem, in German speaking countries the "wait-and-see"approach is widely chosen, although longitudinal studies have found that children with language delay are at risc for cognitive, behavioral and social-emotional problems.\n\nDuring the last few years various forms of early language intervention have been increasingly implemented in German speaking countries. However, they have not been evaluated.\n\nEarly parent-based intervention could be an economical way in prevention speech and language disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '27 Months', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with receptive and/or expressive language abilities below norm range measured by the standardized and norm-referenced German developmental language test SETK-2 (Grimm, 2000)\n\nExclusion Criteria:\n\n* Children with visual impairments, genetic syndromes, metabolic diseases\n* Children with previous language intervention'}, 'identificationModule': {'nctId': 'NCT00625261', 'briefTitle': 'Effectiveness of Early Parent-Based Language Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay', 'orgStudyIdInfo': {'id': '243/2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI', 'interventionNames': ['Other: Heidelberg Parent-based Language Intervention HPLI']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Waiting group, no intervention until children were three years of age'}], 'interventions': [{'name': 'Heidelberg Parent-based Language Intervention HPLI', 'type': 'OTHER', 'otherNames': ['Early language intervention'], 'description': 'The HPLI is a group program for parents of young children with language delay. This 12-14week program includes seven two-our sessions and one three-our session six months later. It is designed for 5 to 10 people and based of an interactive model of language intervention, wich presumes that optimized parental input will provide better language-learning opportunities.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Anke Buschmann, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Joachim Pietz', 'oldOrganization': 'Department of Pediatric Neurology, Chidren´s Hospital, University of Heidelberg'}}}}