Back to resultsEffectiveness of Early Parent-Based Language Intervention
Primary Purpose
Language Delay, Developmental Language Disorders
Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Heidelberg Parent-based Language Intervention HPLI
Sponsored by
About this trial
This is an interventional prevention trial for Language Delay focused on measuring Language delay, Speech and language disorders, Early language intervention, Parent-based language intervention
Eligibility Criteria
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
Sites / Locations
- Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI
Waiting group, no intervention until children were three years of age
Outcomes
Primary Outcome Measures
Receptive and expressive language abilities using standardized instruments (SETK-2, SETK 3-5, AWST, HVS, HASE, HSET)
Secondary Outcome Measures
Parent-report screening questionnaire ELFRA-2 (adoption of the MacArthur Communicative Development Inventories-CDI); cognitive and social-emotional development assessed by standardized instruments,
Full Information
NCT ID
NCT00625261
First Posted
February 19, 2008
Last Updated
February 19, 2008
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT00625261
Brief Title
Effectiveness of Early Parent-Based Language Intervention
Official Title
Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Delay, Developmental Language Disorders
Keywords
Language delay, Speech and language disorders, Early language intervention, Parent-based language intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI
Arm Title
2
Arm Type
No Intervention
Arm Description
Waiting group, no intervention until children were three years of age
Intervention Type
Other
Intervention Name(s)
Heidelberg Parent-based Language Intervention HPLI
Other Intervention Name(s)
Early language intervention
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
27 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Buschmann, MA
Organizational Affiliation
Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Early Parent-Based Language Intervention
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