Effectiveness of Early Parent-Based Language Intervention - Full Text View

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study

Official Title:	Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay

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
1: Experimental 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.
2: No Intervention 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

Responsible Party:	Department of Pediatric Neurology, Chidren´s Hospital, University of Heidelberg ( Prof. Joachim Pietz )
Study ID Numbers:	243/2002
First Received:	February 19, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00625261
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

Language delay

Speech and language disorders

Early language intervention

Parent-based language intervention

Study placed in the following topic categories:

Signs and Symptoms

Language Development Disorders

Neurologic Manifestations

Language Disorders

Neurobehavioral Manifestations

Communication Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00625261