Speech Sound DisorderARCNCT03663972
Age-related Correlates of Treatment for Late-acquired Sounds
A study testing articulation therapy and phonologic treatment in people with Speech Sound Disorder and Phonology Disorder, run by University of Wyoming at 1 site in United States.
Trial summary
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Sound Disorder, Phonology Disorder, Phonology Impairment
- What is being tested?
- articulation therapy and phonologic treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 30 Apr 2020
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusionary Criteria:
- Normal Hearing
- Typical Receptive Language
- Speech Sound Disorder
- No motor speech impairment
- Typical non-verbal intelligence
- Produces at least one late-acquired sound with <7% accuracy
- Monolingual English-speaking
- Typical in terms of motoric and neurological development
Exclusionary Criteria:
- Neurological disorder
- Hearing loss
- Nonverbal IQ < 16th percentile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age-related Correlates of Treatment Efficacy and Efficiency for Late-acquired Sounds
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes.
Read the detailed description
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. However, these sounds are often treated later in a child's life because they are not expected to be fully acquired until quite late--age 7-8 for some sounds. This practice places treatment in a time of the child's development in which they struggle to learn new sounds.The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes, and to examine treatment efficacy and efficiency for two methods of treatment.
- Conditions
- Speech Sound Disorder, Phonology Disorder, Phonology Impairment, Phonological Disorder, Articulation Disorders in Children, Developmental Phonological Disorder
- Being tested
- articulation therapy, phonologic treatment
- Keywords
- treatment, efficacy, efficiency, late-acquired sounds
- Medical subject headings
- Speech Sound Disorder, Articulation Disorders, Speech Disorders, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articulation therapyBehavioural
children receive instruction in producing new sounds at the isolation, syllable and word level.
phonologic treatmentBehavioural
children receive instruction in producing new sounds at the word level
| Study group | Role | What they receive |
|---|---|---|
| Motoric Arm | Active comparator | Children will participate in an intervention based on traditional articulation approaches to speech therapy. Receives: Behavioral: articulation therapy |
| Phonologic Arm | Active comparator | Children will receive intervention that targets the conceptual representation of sounds. Receives: Behavioral: phonologic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy: Number of correct productions of treated speech sounds in treatment words
Accurate Production of treatment sound at baseline and at posttest
Measured: baseline until accuracy criterion is met; up to 18 weeks after final baseline session
Treatment Efficiency: Number of sessions required to meet accuracy criteria
Number of treatment sessions required to meet accuracy criteria (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
Measured: baseline until accuracy criterion is met; up to 18 weeks after final baseline session
Session Length: Mean duration of sessions in minutes
Start and end time of session is recorded on scoresheet, then number of minutes for each session for each participant is found and the mean across all sessions is calculated.
Measured: First treatment session until final treatment session. Final treatment session occurs when accuracy of treatment sound is met (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
Secondary outcomes (1)
Accuracy of production of untreated sounds measured on pretest and posttest probes
Some children may generalize their skills learned through treatment to sounds that were not treated in the trial.
Measured: baseline and at posttest up to 18 weeks after final baseline session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start11 Jun 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Speech Sound 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Young children (age 4-5) and Old children (age 7-8) will be enrolled in either a Motoric behavioral treatment arm or phonological treatment arm.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breanna Irene Krueger, University of Wyoming
- Investigators
- Breanna I. Krueger, PhD, Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663972
- Sponsor's protocol ID
- 20180510BK01978
- Acronym
- ARC
- Status last verified
- Jun 2020
- First submitted
- 31 Aug 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krueger BI, Storkel HL. The impact of age on the treatment of late-acquired sounds in children with speech sound disorders. Clin Linguist Phon. 2023 Sep 2;37(9):783-801. doi: 10.1080/02699206.2022.2093130. Epub 2022 Jul 8.
PubMed 35801558
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Correlates of Treatment Efficacy and Efficiency for Late-acquired Sounds
- ClinicalTrials.gov ID
- NCT03663972
- Acronym / sponsor ID
- ARC / 20180510BK01978
- Conditions
- Speech Sound Disorder, Phonology Disorder, Phonology Impairment, Phonological Disorder, Articulation Disorders in Children, Developmental Phonological Disorder
- Keywords
- treatment, efficacy, efficiency, late-acquired sounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 10 Sep 2018 (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.
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes.
Detailed description
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. However, these sounds are often treated later in a child's life because they are not expected to be fully acquired until quite late--age 7-8 for some sounds. This practice places treatment in a time of the child's development in which they struggle to learn new sounds.The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes, and to examine treatment efficacy and efficiency for two methods of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Young children (age 4-5) and Old children (age 7-8) will be enrolled in either a Motoric behavioral treatment arm or phonological treatment arm.
| Arm | Type | Receives |
|---|---|---|
| Motoric Arm | Active comparator | Behavioral: articulation therapyChildren will participate in an intervention based on traditional articulation approaches to speech therapy. |
| Phonologic Arm | Active comparator | Behavioral: phonologic treatmentChildren will receive intervention that targets the conceptual representation of sounds. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| articulation therapychildren receive instruction in producing new sounds at the isolation, syllable and word level. | Behavioural | Motoric Arm |
| phonologic treatmentchildren receive instruction in producing new sounds at the word level | Behavioural | Phonologic Arm |
Primary outcome
Treatment Efficacy: Number of correct productions of treated speech sounds in treatment words
Time frame: baseline until accuracy criterion is met; up to 18 weeks after final baseline session
Accurate Production of treatment sound at baseline and at posttest
Treatment Efficiency: Number of sessions required to meet accuracy criteria
Time frame: baseline until accuracy criterion is met; up to 18 weeks after final baseline session
Number of treatment sessions required to meet accuracy criteria (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
Session Length: Mean duration of sessions in minutes
Time frame: First treatment session until final treatment session. Final treatment session occurs when accuracy of treatment sound is met (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
Start and end time of session is recorded on scoresheet, then number of minutes for each session for each participant is found and the mean across all sessions is calculated.
1 secondary outcome
Accuracy of production of untreated sounds measured on pretest and posttest probes
Time frame: baseline and at posttest up to 18 weeks after final baseline session
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 18 Jun 2020.
- Derived from this study: PubMed 35801558Krueger BI, Storkel HL. The impact of age on the treatment of late-acquired sounds in children with speech sound disorders. Clin Linguist Phon. 2023 Sep 2;37(9):783-801. doi: 10.1080/02699206.2022.2093130. Epub 2022 Jul 8.
- Individual participant dataSharing planned: No
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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.
Breanna I. Krueger, PhD principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing articulation therapy and phonologic treatment in people with Speech Sound Disorder and Phonology Disorder, run by University of Wyoming 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?
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 18 Jun 2020. 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?
Treatment Efficacy: Number of correct productions of treated speech sounds in treatment words (time frame: baseline until accuracy criterion is met; up to 18 weeks after final baseline session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663972, which also lists 1 linked publication.
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 18 Jun 2020.