Suspended

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

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What is being tested

Heidelberg Parent-based Language Intervention HPLI

Other
Who is being recruted

Behavior+9

+ Communication

+ Communication Disorders

From 24 to 27 Months
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorHeidelberg University
Last updated: January 27, 2026
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Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleEffectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay
NCT00625261
Principal SponsorHeidelberg University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 24 to 27 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorCommunicationCommunication DisordersLanguage Development DisordersLanguage DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsSpeechPathological Conditions, Signs and SymptomsVerbal BehaviorNeurobehavioral Manifestations

Criteria

1 inclusion criteria required to participate
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)
2 exclusion criteria prevent from participating
Children with visual impairments, genetic syndromes, metabolic diseases
Children with previous language intervention

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg

Heidelberg, GermanyOpen Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg in Google Maps
SuspendedOne Study Center