Language DelayPhase 3NCT00625261
Effectiveness of Early Parent-Based Language Intervention
A Phase 3 study testing Heidelberg Parent-based Language Intervention HPLI in people with Language Delay and Developmental Language Disorders, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 24 to 27 months
- Conditions the study is for
- Language Delay, Developmental Language Disorders
- What is being tested?
- Heidelberg Parent-based Language Intervention HPLI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 27 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Children with visual impairments, genetic syndromes, metabolic diseases
- Children with previous language intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg
Heidelberg, D-69120
About this study
Official title: 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.
Read the 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.
- Conditions
- Language Delay, Developmental Language Disorders
- Being tested
- Heidelberg Parent-based Language Intervention HPLI
- Keywords
- Language delay, Speech and language disorders, Early language intervention, Parent-based language intervention
- Medical subject headings
- Language Development Disorders, Speech, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heidelberg Parent-based Language Intervention HPLIOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI Receives: Other: Heidelberg Parent-based Language Intervention HPLI |
| 2 | No intervention | Waiting group, no intervention until children were three years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptive and expressive language abilities using standardized instruments (SETK-2, SETK 3-5, AWST, HVS, HASE, HSET)
Measured: 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,
Measured: at 2;6, 3, 4, 5 and 8 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startOct 2003
- Primary completionFeb 2008
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Anke Buschmann, MA, Principal investigator, Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625261
- Sponsor's protocol ID
- 243/2002
- Status last verified
- Aug 2007
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay
- ClinicalTrials.gov ID
- NCT00625261
- Acronym / sponsor ID
- 243/2002
- Conditions
- Language Delay, Developmental Language Disorders
- Keywords
- Language delay, Speech and language disorders, Early language intervention, Parent-based language intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Oct 2011 (estimated)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Heidelberg Parent-based Language Intervention HPLIThe mothers of the two-years old children in the intervention group took part at the Heidelberg Parent-based Language Intervention HPLI |
| 2 | No intervention | –Waiting group, no intervention until children were three years of age |
Who may qualify
- Ages
- 24 to 27 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Children with visual impairments, genetic syndromes, metabolic diseases
- Children with previous language intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heidelberg Parent-based Language Intervention HPLIAlso: Early language interventionThe 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 | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anke Buschmann, MA principal investigator
Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heidelberg Parent-based Language Intervention HPLI in people with Language Delay and Developmental Language Disorders, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2008.