Effectiveness of Early Parent-Based Language Intervention

NCT00625261 | Unknown Phase 3 DMC

• 1 other identifier: 243/2002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Language Delay; Developmental Language Disorders

Keywords

Language delay; Speech and language disorders; Early language intervention; Parent-based language intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

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

2

NO INTERVENTION

Waiting group, no intervention until children were three years of age

Interventions

Heidelberg Parent-based Language Intervention HPLI OTHER

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.

Also known as: Early language intervention

1

Eligibility Criteria

• Age: 24 Months - 27 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Children with visual impairments, genetic syndromes, metabolic diseases
• Children with previous language intervention

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg

Heidelberg, D-69120, Germany

Location

MeSH Terms

Conditions

Language Development Disorders; Speech; Language Disorders

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Study Officials

• Anke Buschmann, MA

  Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: October 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: October 1, 2011
• Last Updated: February 28, 2008

Record last verified: 2007-08

Locations

DE (1)