Effectiveness of Early Parent-Based Language Intervention

February 19, 2008 updated by: Heidelberg University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Heidelberg, Germany, D-69120
        • Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
The mothers of the two-years old children in the intervention group took part at the 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 Names:
  • Early language intervention
No Intervention: 2
Waiting group, no intervention until children were three years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 2; 6, 3, 4, 5 and 8 years of age

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 2;6, 3, 4, 5 and 8 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anke Buschmann, MA, Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

February 1, 2008

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2008

Last Update Submitted That Met QC Criteria

February 19, 2008

Last Verified

August 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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