Effectiveness of Early Parent-Based Language Intervention

Language Delay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00625261
• Other study ID #: 243/2002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 19, 2008
• Last updated: February 19, 2008
• Start date: October 2003
• Est. completion date: October 2011

Study information

• Verified date: August 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 2011
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 27 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Developmental Language Disorders
• Language Delay
• Language Development Disorders
• Language Disorders

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receptive and expressive language abilities using standardized instruments (SETK-2, SETK 3-5, AWST, HVS, HASE, HSET)		at 2; 6, 3, 4, 5 and 8 years of age	Yes
Secondary	Parent-report screening questionnaire ELFRA-2 (adoption of the MacArthur Communicative Development Inventories-CDI); cognitive and social-emotional development assessed by standardized instruments,		at 2;6, 3, 4, 5 and 8 years of age	Yes