Developmental Language DisorderNCT04531514
A Framework For Linking Sequential Pattern Rules in DLD: Perception in Toddlers
A study testing Sensitivity to phonological rules & referents OR: Toddlers and Sensitivity to phonological rules & referents FR: Toddlers in people with Developmental Language Disorder and Speech Sound Disorder, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial summary
This broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful… Read more about this study
- Who is it for?
- Ages 19 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder, Speech Sound Disorder, Specific Language Impairment
- What is being tested?
- Sensitivity to phonological rules & referents OR: Toddlers and Sensitivity to phonological rules & referents FR: Toddlers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 17 May 2025
- Phase
- Interventional
- 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 19 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Toddlers will, based on parent case history report, have
- normal hearing
- no medical or developmental concerns
- Language, speech, social, and motor development will be reported as within the expected range
- dominant exposure to English from infancy
- expressive vocabulary above the 10th percentile on the MacArthur-Bates Communicative Development Inventory (CDI; Fenson et al., 2006).
Who cannot join
- Participants will be excluded who have
- hearing impairment
- intellectual impairment
- autism
- significant motor impairment
- reported histories of developmental, speech, language, or hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Developmental Framework For Linking Phonological and Morphosyntactic Sequential Pattern Rules in Developmental Language Disorder
This broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful interventions for children with developmental language disorder (DLD; AKA specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.
Read the detailed description
The developmental approach taken here combines what we already know about morpho-syntactic deficits in DLD with recent developments in the fields of linguistics and language acquisition. First, it is possible to divide phonological and morphological patterns into three pattern types (Single Feature, OR/Disjunction, Family Resemblance/Prototype), with these types having a long history of study in visual pattern learning. Importantly, children with DLD appear to have maximum difficulty with morpho-syntactic patterns of the OR type (e.g., regular past tense; add a "t" if the final consonant is voiceless OR a "d" if the final consonant is voiced). In contrast, studies using artificial grammars show that infants who are typically developing are highly adept at learning Single Feature and OR pattern types; Family Resemblance patterns may be weaker. Family resemblance patterns relate to similarity, and may be more closely tied to the lexicon than to grammar (e.g., beagles and terriers are similar and they are both dogs; the words "goat" and "boat" are similar). Typical adults are adept at Single Feature and Family Resemblance patterns, but appear to be, at least superficially, more like children with DLD in their performance on the OR pattern.
With these intriguing findings as a starting point, the proposed research links phonological and morphological sequence learning in children with developmental language disorder (DLD). In the studies focused on children, we ask if 4- to 6-year-olds who are typically developing as well as those with DLD (both with and without co-occurring speech sound deficits) and speech sound disorder (SSD; without co-occurring morpho-syntactic deficits) are sensitive to input examples that fit one of these three patterns. Our hypothesis is that, consistent with their long-documented morpho-syntactic deficit, children with DLD will have particular difficulty with the OR pattern. Consistent with their intact morpho-syntactic skills, children with SSD should show no deficits in the OR pattern, revealing a link between OR pattern learning, phonology, and morpho-syntax. Our endpoint measure is that children with DLD (both with and without an accompanying SSD) do not show sensitivity to the OR pattern, as measured by sound pattern (e.g., phonetic accuracy, syllable sequence stability) and motor learning (e.g., articulatory and acoustic variability) measures.
This hypothesis is assessed by indexing the learning trajectory across the training period and during generalization to new nonwords that are consistent or inconsistent with the training pattern. In the generalization phase, children are asked to name new novel words that are either consistent (i.e., that fit the training rule) or inconsistent (i.e., that do not fit the training rule) nonwords. It is predicted that children with TD and SSD, who are still in a period of language learning plasticity (they can still learn the sound patterns and grammar of a second language) will be sensitive to all three patterns. However, children with DLD (both with and without accompanying SSD) are predicted to show sensitivity to the family resemblance and single feature patterns, but not to the critical OR pattern-the one associated with sound pattern and grammatical learning, This would reveal an important connection between sound pattern and grammatical learning, which could lead to earlier diagnosis (phonological patterns emerge earlier than grammar) and to more general intervention practices that focus on sequential pattern learning rather than specific language goals may be efficacious.
A second aim explores whether the inclusion of a semantic subcategory cue facilitates learning the OR pattern. The hypothesis is that children with DLD (as well as typical adults) who initially are predicted to have the most difficulty with the OR pattern, will show increases in sensitivity following the addition of a semantic category cue (e.g., animals for the voiced consonant rule OR tools for the voiceless consonant rule). This result would be especially important for learners with DLD, as it may provide a pathway for intervention of a core learning deficit.
Critically, these studies are developmental in nature. In the adult component of this research, we ask if adults are sensitive to input examples that fit one of these three patterns. Our hypothesis, based on previous findings from the Gerken lab, is that adults, like children with DLD, do not show sensitivity to the OR pattern. However, adults are sensitive to single feature and Family Resemblance patterns. Adults still learn words readily and are sensitive to family resemblance prototype relationships. For adults, perceptual measures index sensitivity. Similar to the children with typical development, DLD and SSD, we explore whether the inclusion of a semantic subcategory cue facilitates learning the OR pattern in adults. The hypothesis is that all learners, including adults, will show increases in sensitivity following the addition of a semantic category cue (e.g., animals for voiced rule OR tools for voiceless rule). The findings from adults contribute to a dynamic developmental framework. Because of the dramatic developmental changes in sensitivity to phonological sound patterns and the presumed linkage of such patterns to morpho-syntax, the data from adults are essential in identifying the underlying mechanism(s) of DLD and to suggesting possible intervention strategies, such as employing semantic cues to the OR pattern and strengthening lexical organization.
From previous work, we know that infants are sensitive to the OR rule. In the studies focused on toddlers, we ask if dependence on the associatively organized lexicon can account for the infant-to-adult developmental changes observed for the OR pattern (which is not associatively organized) and thereby explores the possibility that children with DLD rely on their lexicons to compensate for their sequential pattern learning deficit. The hypothesis is that 20-month-old children, who are just entering a period of rapid vocabulary learning, will show increased sensitivity (based on looking time to words that are consistent vs. inconsistent within the training set) in the family resemblance condition when a visual referent (i.e., semantic cue) is added, but decreased sensitivity in the OR condition when a visual referent is added. These results will also be related to vocabulary size as reported on the CDI, with the prediction that robust patterns are smaller for children who received referents or who have smaller vocabularies for the OR pattern and greater for children who received referents or who have larger vocabularies for the family resemblance pattern. The results from toddlers, who are just entering a period of rapid vocabulary learning, provide an essential framework for understanding how different types of phonological patterns apply to lexical and morpho-syntactic learning, The results of the proposed study provide a critical developmental framework for identifying the underlying mechanism(s) of DLD. These findings will also lead to the development of intervention strategies, such as strengthening lexical organization, to support problematic aspects of sequential pattern learning.
- Being tested
- Sensitivity to phonological rules & referents OR: Toddlers, Sensitivity to phonological rules & referents FR: Toddlers
- Medical subject headings
- Language Development Disorders, Speech Sound Disorder, Specific Language Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitivity to phonological rules & referents OR: ToddlersOther
Assess whether the inclusion of a semantic reference decreases OR phonological rule learning
Sensitivity to phonological rules & referents FR: ToddlersOther
Assess whether the inclusion of a semantic reference increases FR phonological rule learning
| Study group | Role | What they receive |
|---|---|---|
| Sensitivity to phonological rules & referents OR: Toddlers | Experimental | OR condition Receives: Other: Sensitivity to phonological rules & referents OR: Toddlers |
| Sensitivity to phonological rules & referents FR: Toddlers | Experimental | Family Resemblance condition Receives: Other: Sensitivity to phonological rules & referents FR: Toddlers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toddlers' ability to learn different types of sound patterns measured by listening times
Learning will be assessed during the generalization phase. First, each toddler will be given a difference score resulting from mean listening time for consistent minus mean listening time for inconsistent test trials. It is predicted that toddlers will show increased learning of the OR rule in the non-referential condition. Higher vocabulary on the CDI will correspond with weaker performance.
Measured: Generalization Phase which will last 3-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start3 Aug 2020
- Primary completion17 May 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Toddlers will be assigned randomly to one of four conditions: OR condition with a referent; OR condition without a referent; Family Resemblance condition with a referent; Family Resemblance condition without a referent.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Goffman, Father Flanagan's Boys' Home
- Investigators
- Lisa Goffman, PhD, Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531514
- Sponsor's protocol ID
- 2004574003R002 - Toddlers
- Status last verified
- Oct 2025
- First submitted
- 20 Aug 2020
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: These data are transferring from University of Arizona to Boys Town National Research Hospital following the death of Dr. LouAnn Gerken. If the IRB allows, de-identified data will be posted on open science framework.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Developmental Framework For Linking Phonological and Morphosyntactic Sequential Pattern Rules in Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT04531514
- Acronym / sponsor ID
- 2004574003R002 - Toddlers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 28 Aug 2020 (actual)
- 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.
This broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful interventions for children with developmental language disorder (DLD; AKA specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.
Detailed description
The developmental approach taken here combines what we already know about morpho-syntactic deficits in DLD with recent developments in the fields of linguistics and language acquisition. First, it is possible to divide phonological and morphological patterns into three pattern types (Single Feature, OR/Disjunction, Family Resemblance/Prototype), with these types having a long history of study in visual pattern learning. Importantly, children with DLD appear to have maximum difficulty with morpho-syntactic patterns of the OR type (e.g., regular past tense; add a "t" if the final consonant is voiceless OR a "d" if the final consonant is voiced). In contrast, studies using artificial grammars show that infants who are typically developing are highly adept at learning Single Feature and OR pattern types; Family Resemblance patterns may be weaker. Family resemblance patterns relate to similarity, and may be more closely tied to the lexicon than to grammar (e.g., beagles and terriers are similar and they are both dogs; the words "goat" and "boat" are similar). Typical adults are adept at Single Feature and Family Resemblance patterns, but appear to be, at least superficially, more like children with DLD in their performance on the OR pattern.
With these intriguing findings as a starting point, the proposed research links phonological and morphological sequence learning in children with developmental language disorder (DLD). In the studies focused on children, we ask if 4- to 6-year-olds who are typically developing as well as those with DLD (both with and without co-occurring speech sound deficits) and speech sound disorder (SSD; without co-occurring morpho-syntactic deficits) are sensitive to input examples that fit one of these three patterns. Our hypothesis is that, consistent with their long-documented morpho-syntactic deficit, children with DLD will have particular difficulty with the OR pattern. Consistent with their intact morpho-syntactic skills, children with SSD should show no deficits in the OR pattern, revealing a link between OR pattern learning, phonology, and morpho-syntax. Our endpoint measure is that children with DLD (both with and without an accompanying SSD) do not show sensitivity to the OR pattern, as measured by sound pattern (e.g., phonetic accuracy, syllable sequence stability) and motor learning (e.g., articulatory and acoustic variability) measures.
This hypothesis is assessed by indexing the learning trajectory across the training period and during generalization to new nonwords that are consistent or inconsistent with the training pattern. In the generalization phase, children are asked to name new novel words that are either consistent (i.e., that fit the training rule) or inconsistent (i.e., that do not fit the training rule) nonwords. It is predicted that children with TD and SSD, who are still in a period of language learning plasticity (they can still learn the sound patterns and grammar of a second language) will be sensitive to all three patterns. However, children with DLD (both with and without accompanying SSD) are predicted to show sensitivity to the family resemblance and single feature patterns, but not to the critical OR pattern-the one associated with sound pattern and grammatical learning, This would reveal an important connection between sound pattern and grammatical learning, which could lead to earlier diagnosis (phonological patterns emerge earlier than grammar) and to more general intervention practices that focus on sequential pattern learning rather than specific language goals may be efficacious.
A second aim explores whether the inclusion of a semantic subcategory cue facilitates learning the OR pattern. The hypothesis is that children with DLD (as well as typical adults) who initially are predicted to have the most difficulty with the OR pattern, will show increases in sensitivity following the addition of a semantic category cue (e.g., animals for the voiced consonant rule OR tools for the voiceless consonant rule). This result would be especially important for learners with DLD, as it may provide a pathway for intervention of a core learning deficit.
Critically, these studies are developmental in nature. In the adult component of this research, we ask if adults are sensitive to input examples that fit one of these three patterns. Our hypothesis, based on previous findings from the Gerken lab, is that adults, like children with DLD, do not show sensitivity to the OR pattern. However, adults are sensitive to single feature and Family Resemblance patterns. Adults still learn words readily and are sensitive to family resemblance prototype relationships. For adults, perceptual measures index sensitivity. Similar to the children with typical development, DLD and SSD, we explore whether the inclusion of a semantic subcategory cue facilitates learning the OR pattern in adults. The hypothesis is that all learners, including adults, will show increases in sensitivity following the addition of a semantic category cue (e.g., animals for voiced rule OR tools for voiceless rule). The findings from adults contribute to a dynamic developmental framework. Because of the dramatic developmental changes in sensitivity to phonological sound patterns and the presumed linkage of such patterns to morpho-syntax, the data from adults are essential in identifying the underlying mechanism(s) of DLD and to suggesting possible intervention strategies, such as employing semantic cues to the OR pattern and strengthening lexical organization.
From previous work, we know that infants are sensitive to the OR rule. In the studies focused on toddlers, we ask if dependence on the associatively organized lexicon can account for the infant-to-adult developmental changes observed for the OR pattern (which is not associatively organized) and thereby explores the possibility that children with DLD rely on their lexicons to compensate for their sequential pattern learning deficit. The hypothesis is that 20-month-old children, who are just entering a period of rapid vocabulary learning, will show increased sensitivity (based on looking time to words that are consistent vs. inconsistent within the training set) in the family resemblance condition when a visual referent (i.e., semantic cue) is added, but decreased sensitivity in the OR condition when a visual referent is added. These results will also be related to vocabulary size as reported on the CDI, with the prediction that robust patterns are smaller for children who received referents or who have smaller vocabularies for the OR pattern and greater for children who received referents or who have larger vocabularies for the family resemblance pattern. The results from toddlers, who are just entering a period of rapid vocabulary learning, provide an essential framework for understanding how different types of phonological patterns apply to lexical and morpho-syntactic learning, The results of the proposed study provide a critical developmental framework for identifying the underlying mechanism(s) of DLD. These findings will also lead to the development of intervention strategies, such as strengthening lexical organization, to support problematic aspects of sequential pattern learning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Toddlers will be assigned randomly to one of four conditions: OR condition with a referent; OR condition without a referent; Family Resemblance condition with a referent; Family Resemblance condition without a referent.
| Arm | Type | Receives |
|---|---|---|
| Sensitivity to phonological rules & referents OR: Toddlers | Experimental | Other: Sensitivity to phonological rules & referents OR: ToddlersOR condition |
| Sensitivity to phonological rules & referents FR: Toddlers | Experimental | Other: Sensitivity to phonological rules & referents FR: ToddlersFamily Resemblance condition |
Who may qualify
- Ages
- 19 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Toddlers will, based on parent case history report, have
- normal hearing
- no medical or developmental concerns
- Language, speech, social, and motor development will be reported as within the expected range
- dominant exposure to English from infancy
Key exclusion criteria (6 listed)
- Participants will be excluded who have
- hearing impairment
- intellectual impairment
- autism
- significant motor impairment
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 |
|---|---|---|
| Sensitivity to phonological rules & referents OR: ToddlersAssess whether the inclusion of a semantic reference decreases OR phonological rule learning | Other | Sensitivity to phonological rules & referents OR: Toddlers |
| Sensitivity to phonological rules & referents FR: ToddlersAssess whether the inclusion of a semantic reference increases FR phonological rule learning | Other | Sensitivity to phonological rules & referents FR: Toddlers |
Primary outcome
Toddlers' ability to learn different types of sound patterns measured by listening times
Time frame: Generalization Phase which will last 3-5 minutes
Learning will be assessed during the generalization phase. First, each toddler will be given a difference score resulting from mean listening time for consistent minus mean listening time for inconsistent test trials. It is predicted that toddlers will show increased learning of the OR rule in the non-referential condition. Higher vocabulary on the CDI will correspond with weaker performance.
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 27 Oct 2025.
- Individual participant dataSharing planned: Undecided. These data are transferring from University of Arizona to Boys Town National Research Hospital following the death of Dr. LouAnn Gerken. If the IRB allows, de-identified data will be posted on open science framework.
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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.
Lisa Goffman, PhD principal investigator
Father Flanagan's Boys' Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitivity to phonological rules & referents OR: Toddlers and Sensitivity to phonological rules & referents FR: Toddlers in people with Developmental Language Disorder and Speech Sound Disorder, run by Father Flanagan's Boys' Home at 1 site 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 6 inclusion and 6 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 27 Oct 2025. 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 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.
What does the primary outcome measure?
Toddlers' ability to learn different types of sound patterns measured by listening times (time frame: Generalization Phase which will last 3-5 minutes). 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 27 Oct 2025.