Developmental Articulation DisorderNCT00001551
Characteristics of Idiopathic Familial Speech Disorders
An observational study of Developmental Articulation Disorder and Speech Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites in United States.
Trial summary
According to studies, speech disorders with unknown causes (idiopathic) affect approximately 5% of the population at some point in their life. Some of these disorders like, stuttering and cluttering, are known for being detected early, during speech development. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Developmental Articulation Disorder, Speech Disorder, Stuttering
- How many people
- 375 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 1996to 13 Nov 2009
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A family history of an autosomal dominant pattern of inheritance of the speech disorder over several generations with persistence into adulthood in some cases,
- Speech symptoms during conversational speech include: deletion of final consonants; syllable reduction and syllable deletion; deletion of grammatical markers such as copulas, auxiliaries, prepositions, connectives; poor ability to self-correct; poor awareness of errors; and consonant cluster reduction.
- Greater than 9% discourse errors during analysis of a sample of 300 syllables.
- A discrepancy of 30 points (1 and 1/2 Standard Deviations) between receptive (the higher score) and expressive percentile score on the PPVT III and Expressive Vocabulary Test.
- For subjects greater than 7 years of age, a phonological process rating of 3 or more for any phonological process on the Khan-Lewis Phonological Analysis. For subjects less than 7 years of age, a phonological process rating of 3 or more on 2 phonological processes on the Khan-Lewis Phonological Analysis. Finally, any subjects with a non developmental phonological process error will be identified as potentially having FPPD.
Who cannot join
- Anyone with a hearing loss will be excluded from participation during the diagnostic testing.
- Children with delayed language, more than 1 year delay from norms on receptive and expression language testing will be excluded.
- Language impairment: scores more than 2 standard deviations below the age appropriate score on the standardized language tests listed under the inclusion criteria.
- Cognitive impairment: scores more than 2 standard deviations below the age appropriate score on the standardized cognitive tests listed under the inclusion criteria.
- Bilingual non-native English speakers - Studies have demonstrated that brain organization for speech and language may differ in bilingual persons. It is hypothesized that this may alter speech motor learning and thus kinematic data from non-native English speakers would differ from native English speakers. Therefore, only native-American English speakers, with only one language spoken in the home, will be included.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, College Park
College Park, Maryland
University of Wisconsin
Madison, Wisconsin, 53792
About this study
According to studies, speech disorders with unknown causes (idiopathic) affect approximately 5% of the population at some point in their life. Some of these disorders like, stuttering and cluttering, are known for being detected early, during speech development.
Stuttering is characterized by sound and syllable repetitions and consonant/vowel prolongations. When stuttering is moderate to severe, it can interfere with a person's job and social activities.
Read more
Speech articulation disorders are characterized by omissions, or substitutions of speech sounds. The speech of a person who clutters is often difficult to understand. People are often unaware of the errors they make when speaking causing treatment of the condition to be very difficult.
The purpose of this research is to study an extended family whose members exhibit a pure form of speech articulation disorders
In addition, the study will use data and information gathered from the study and use it to develop guidelines (criteria) for defining and differentiating patients with speech disorders.
Read the detailed description
Objective:
Our objective is to determine which factors are involved in the development of stuttering and familial phonological processing disorder and are associated with a familial pattern of inheritance.
Study population: The study population is comprised of 8 groups:
- Children and adults with persistent developmental stuttering;
- Unaffected siblings of the individuals affected with developmental stuttering or recovered from stuttering
- Children and adults who have recovered from developmental stuttering;
- Children and adults with persistent familial phonological processing disorders (FPPD);
- Unaffected siblings of the individuals affected with FPPD or have recovered from FPPD
- Children and adults who have recovered from FPPD;
- Unaffected siblings of the individuals who have recovered from FPPD;
- Children and adults with normal speech and language development who will comprise the control groups.
Design: A Natural history design will be used to compare affected and unaffected family members with healthy volunteers with normal speech and language.
Outcome Measures: Genetic markers and pedigree analyses will be used to test familial inheritance patterns. Speech and language development will be compared using indices of speech perception, auditory perception, self monitoring of one's own speech, language complexity, motor complexity, speech learning, phonological processing and verbal/nonverbal memory.
- Keywords
- Stuttering, Linkage, Pedigree, Speech Articulation, Phonological Processing Disorders, Speech Disorder
- Medical subject headings
- Articulation Disorders, Speech Disorders, Stuttering
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start22 May 1996
- Primary completion13 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental Articulation DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 375 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001551
- Sponsor's protocol ID
- 960088
- Other IDs
- 96-N-0088
- Status last verified
- 13 Nov 2009
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Plomin R, Owen MJ, McGuffin P. The genetic basis of complex human behaviors. Science. 1994 Jun 17;264(5166):1733-9. doi: 10.1126/science.8209254.
PubMed 8209254Cox NJ, Seider RA, Kidd KK. Some environmental factors and hypotheses for stuttering in families with several stutterers. J Speech Hear Res. 1984 Dec;27(4):543-8. doi: 10.1044/jshr.2704.543.
PubMed 6521460Felsenfeld S, McGue M, Broen PA. Familial aggregation of phonological disorders: results from a 28-year follow-up. J Speech Hear Res. 1995 Oct;38(5):1091-107. doi: 10.1044/jshr.3805.1091.
PubMed 8558878
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Idiopathic Familial Speech Disorders
- ClinicalTrials.gov ID
- NCT00001551
- Acronym / sponsor ID
- 960088
- Keywords
- Stuttering, Linkage, Pedigree, Speech Articulation, Phonological Processing Disorders, Speech Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 22 May 1996
- Primary completion
- 13 Nov 2009 (actual)
- First posted
- 4 Nov 1999 (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.
According to studies, speech disorders with unknown causes (idiopathic) affect approximately 5% of the population at some point in their life. Some of these disorders like, stuttering and cluttering, are known for being detected early, during speech development.
Stuttering is characterized by sound and syllable repetitions and consonant/vowel prolongations. When stuttering is moderate to severe, it can interfere with a person's job and social activities.
Speech articulation disorders are characterized by omissions, or substitutions of speech sounds. The speech of a person who clutters is often difficult to understand. People are often unaware of the errors they make when speaking causing treatment of the condition to be very difficult.
The purpose of this research is to study an extended family whose members exhibit a pure form of speech articulation disorders
In addition, the study will use data and information gathered from the study and use it to develop guidelines (criteria) for defining and differentiating patients with speech disorders.
Detailed description
Objective:
Our objective is to determine which factors are involved in the development of stuttering and familial phonological processing disorder and are associated with a familial pattern of inheritance.
Study population: The study population is comprised of 8 groups:
- Children and adults with persistent developmental stuttering;
- Unaffected siblings of the individuals affected with developmental stuttering or recovered from stuttering
- Children and adults who have recovered from developmental stuttering;
- Children and adults with persistent familial phonological processing disorders (FPPD);
- Unaffected siblings of the individuals affected with FPPD or have recovered from FPPD
- Children and adults who have recovered from FPPD;
- Unaffected siblings of the individuals who have recovered from FPPD;
- Children and adults with normal speech and language development who will comprise the control groups.
Design: A Natural history design will be used to compare affected and unaffected family members with healthy volunteers with normal speech and language.
Outcome Measures: Genetic markers and pedigree analyses will be used to test familial inheritance patterns. Speech and language development will be compared using indices of speech perception, auditory perception, self monitoring of one's own speech, language complexity, motor complexity, speech learning, phonological processing and verbal/nonverbal memory.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A family history of an autosomal dominant pattern of inheritance of the speech disorder over several generations with persistence into adulthood in some cases,
- Speech symptoms during conversational speech include: deletion of final consonants; syllable reduction and syllable deletion; deletion of grammatical markers such as copulas, auxiliaries, prepositions, connectives; poor ability to self-correct; poor awareness of errors; and consonant cluster reduction.
- Greater than 9% discourse errors during analysis of a sample of 300 syllables.
- A discrepancy of 30 points (1 and 1/2 Standard Deviations) between receptive (the higher score) and expressive percentile score on the PPVT III and Expressive Vocabulary Test.
- For subjects greater than 7 years of age, a phonological process rating of 3 or more for any phonological process on the Khan-Lewis Phonological Analysis. For subjects less than 7 years of age, a phonological process rating of 3 or more on 2 phonological processes on the Khan-Lewis Phonological Analysis. Finally, any subjects with a non developmental phonological process error will be identified as potentially having FPPD.
Key exclusion criteria (5 listed)
- Anyone with a hearing loss will be excluded from participation during the diagnostic testing.
- Children with delayed language, more than 1 year delay from norms on receptive and expression language testing will be excluded.
- Language impairment: scores more than 2 standard deviations below the age appropriate score on the standardized language tests listed under the inclusion criteria.
- Cognitive impairment: scores more than 2 standard deviations below the age appropriate score on the standardized cognitive tests listed under the inclusion criteria.
- Bilingual non-native English speakers - Studies have demonstrated that brain organization for speech and language may differ in bilingual persons. It is hypothesized that this may alter speech motor learning and thus kinematic data from non-native English speakers would differ from native English speakers. Therefore, only native-American English speakers, with only one language spoken in the home, will be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8209254Plomin R, Owen MJ, McGuffin P. The genetic basis of complex human behaviors. Science. 1994 Jun 17;264(5166):1733-9. doi: 10.1126/science.8209254.
- Background: PubMed 6521460Cox NJ, Seider RA, Kidd KK. Some environmental factors and hypotheses for stuttering in families with several stutterers. J Speech Hear Res. 1984 Dec;27(4):543-8. doi: 10.1044/jshr.2704.543.
- Background: PubMed 8558878Felsenfeld S, McGue M, Broen PA. Familial aggregation of phonological disorders: results from a 28-year follow-up. J Speech Hear Res. 1995 Oct;38(5):1091-107. doi: 10.1044/jshr.3805.1091.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Articulation Disorder and Speech Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001551, which also lists 3 linked publications.
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 2 Jul 2017.