Trial record 6 of 13 for:    "Language Development Disorders"

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 Heidelberg University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00625261
First received: February 19, 2008
Last updated: NA
Last verified: August 2007
History: No changes posted
  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 Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
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 Heidelberg University:
Language delay
Speech and language disorders
Early language intervention
Parent-based language intervention

Additional relevant MeSH terms:
Language Development Disorders
Language Disorders
Communication Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014