Effectiveness of Early Parent-Based Language Intervention
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University of Heidelberg.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00625261
First received: February 19, 2008
Last updated: NA
Last verified: August 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Language Delay Developmental Language Disorders |
Other: Heidelberg Parent-based Language Intervention HPLI |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay |
Resource links provided by NLM:
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
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, [ Time Frame: at 2;6, 3, 4, 5 and 8 years of age ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | October 2011 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI
|
Other: Heidelberg Parent-based Language Intervention HPLI
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 Name: Early language intervention
|
|
No Intervention: 2
Waiting group, no intervention until children were three years of age
|
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.
Eligibility| Ages Eligible for Study: | 24 Months to 27 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625261
Locations
| Germany | |
| Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg | |
| Heidelberg, Germany, D-69120 | |
Sponsors and Collaborators
University of Heidelberg
Investigators
| Principal Investigator: | Anke Buschmann, MA | Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg |
More Information
No publications provided
| Responsible Party: | Prof. Joachim Pietz, Department of Pediatric Neurology, Chidren´s Hospital, University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00625261 History of Changes |
| Other Study ID Numbers: | 243/2002 |
| Study First Received: | February 19, 2008 |
| Last Updated: | February 19, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Heidelberg:
|
Language delay Speech and language disorders Early language intervention Parent-based language intervention |
Additional relevant MeSH terms:
|
Language Development Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013