- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625261
Effectiveness of Early Parent-Based Language Intervention
Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
During the last few years various forms of early language intervention have been increasingly implemented in German speaking countries. However, they have not been evaluated.
Early parent-based intervention could be an economical way in prevention speech and language disorders.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Heidelberg, Germany, D-69120
- Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Children with visual impairments, genetic syndromes, metabolic diseases
- Children with previous language intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI
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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.
Other Names:
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No Intervention: 2
Waiting group, no intervention until children were three years of age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Receptive and expressive language abilities using standardized instruments (SETK-2, SETK 3-5, AWST, HVS, HASE, HSET)
Time Frame: at 2; 6, 3, 4, 5 and 8 years of age
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at 2; 6, 3, 4, 5 and 8 years of age
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Parent-report screening questionnaire ELFRA-2 (adoption of the MacArthur Communicative Development Inventories-CDI); cognitive and social-emotional development assessed by standardized instruments,
Time Frame: at 2;6, 3, 4, 5 and 8 years of age
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at 2;6, 3, 4, 5 and 8 years of age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anke Buschmann, MA, Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 243/2002
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