Overview

This trial is active, not recruiting.

Conditions language delay, developmental language disorders
Treatment heidelberg parent-based language intervention hpli
Phase phase 3
Sponsor Heidelberg University
Start date October 2003
End date February 2008
Trial size 150 participants
Trial identifier NCT00625261, 243/2002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Experimental)
The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI
heidelberg parent-based language intervention hpli Early language intervention
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.
(No Intervention)
Waiting group, no intervention until children were three years of age

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 24 months up to 27 months old.

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

Additional Information

Official title Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay
Principal investigator Anke Buschmann, MA
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Heidelberg University.