Speech Sound DisorderNCT06075303
Dynamic Assessment of Phonological Disorders
A study testing Modified Cycles in people with Speech Sound Disorder, run by University of Montana.
Trial summary
The goal of this clinical trial is to learn about (1) how speech skills can be measured and how various tests give speech therapists different types of information for children with speech sound disorder, and (2) whether changes occur in the amount of help children need when they work on easier sounds or harder sounds… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- Modified Cycles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2011to 11 May 2012
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- monolingual English speakers;
- scores in the mild to profound range for phonological disorder based on the Hodson Assessment of Phonological Patterns (Hodson, 2004);
- scores above 9th percentile on receptive language and cognitive abilities based on measures from the Preschool Language Scale-4 (PLS-4) (Zimmerman, Steiner, \& Pond, 2002) and the Peabody Picture Vocabulary Test (PPVT) (Dunn \& Dunn, 1997);
- perform adequately on a structural-functional examination adapted from the Oral and Speech Motor Control Protocol (Robbins \& Klee, 1987) and Motor Speech Examination (Strand \& McCauley, 1999);
- exhibit voice and fluency skills within normal limits,
- pass a hearing screening adequate for understanding speech.
Who cannot join
- will not exhibit the prime characteristics of developmental apraxia of speech and/or dysarthria
About this study
Official title: Dynamic Assessment of Phonological Disorders: Part 1 Assessment & Part 2 Treatment
The goal of this clinical trial is to learn about (1) how speech skills can be measured and how various tests give speech therapists different types of information for children with speech sound disorder, and (2) whether changes occur in the amount of help children need when they work on easier sounds or harder sounds during treatment. The main questions this study aims to answer are: (1) what does one type of test (dynamic assessment) tell us about speech skills compared to another type of test (static assessment), and (2) does practice of easier or harder sounds show differences in progress. Participants will complete 16 sessions of speech treatment called "modified cycles treatment", and will complete several speech and language tests before, during, and after treatment by pointing to pictures, and saying sounds, words, and sentences.
Read the detailed description
The Glaspey Dynamic Assessment of Phonology (GDAP) (Glaspey, 2006; Glaspey \& Stoel-Gammon, 2007) was initially developed because children with speech-sound delays make very slow progress in speech therapy and it is difficult to document change in short periods of time using traditional methods of assessment. The traditional methods rely on picture-naming tasks and the child is not given any assistance in speech productions. The lack of assistance often results in a floor effect in the documentation of change and progress. Without good documentation of change, speech-language pathologists are left uncertain about the efficacy of the treatment that they are administering. The GDAP is unique because it assesses change based on dynamic assessment; children are systematically given assistance in the production of speech sounds. When administering the GDAP, clinicians rate each sound on a 15-point ordinal scale that represents the number of cues and assistance that could be used to assist the child in sound production. Progress is documented as children need less support over time and their scores decrease. This study compares the GDAP with a traditional single-word measure. This study also has an extension to use the GDAP to select easier or harder targets during treatment, and monitor children's progress across measures over 8 weeks of modified cycles treatment. The treatment will include 16 sessions of therapy with two 50-minute sessions per week. The treatment approach that will be used is called "Cycles" and involves practicing a different speech sound each week (Rudolf \& Wendt, 2014). The sounds that are practiced will be individualized to each child's needs, with harder sounds taught during four of the weeks and easier sounds taught during four of the weeks. The order will be counter-balanced across participants.
- Conditions
- Speech Sound Disorder
- Being tested
- Modified Cycles
- Keywords
- phonology, delay, disorder, speech
- Medical subject headings
- Speech Sound Disorder, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified CyclesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Easier Targets | Experimental | All participants will participate in a modified Cycles approach where speech targets are worked on for a short period of time and switched within a cycle. During the Easier Targets arm, children will work on target sounds that are "easier" based on their pre-treatment scores of 8, 9, 10, or 11 on the Glaspey Dynamic Assessment of Phonology. Children will complete 8 sessions in this arm that are each 50-minutes long and occur two times per week with each target addressed for 2 sessions. Receives: Behavioral: Modified Cycles |
| Harder Targets | Experimental | All participants will participate in a modified Cycles approach where speech targets are worked on for a short period of time and switched within a cycle. During the Harder Targets arm, children will work on target sounds that are "harder" based on their pre-treatment scores of 15, 14, 13, or 12 on the Glaspey Dynamic Assessment of Phonology. Children will complete 8 sessions in this arm that are each 50-minutes long and occur two times per week with each target addressed for 2 sessions. Receives: Behavioral: Modified Cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glaspey Dynamic Assessment of Phonology (GDAP)
The GDAP is an evaluation of speech sounds when given help while talking about pictures.
The child is asked to say all sounds by themselves, in words, or in sentences. The child is given verbal modeling and instructions to help him/her say the sounds correctly to the highest level possible (i.e. sentences without any model).
Measured: Prior to treatment, after four weeks of treatment, and again after eight weeks.
Secondary outcomes (1)
Static Assessment of Single Words
Evaluation of speech sounds in words using pictures. The child will be shown 50-80 picture cards and asked to say the pictures. There pictures feature sounds that may be in error by the child.
Measured: Prior to treatment, after four weeks of treatment, and again after eight weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start4 Oct 2011
- Primary completion11 May 2012
- Study completion11 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Children will engage in 4 weeks of treatment on easier targets and 4 weeks of treatment on harder targets. The order (easier first or harder first) will be counterbalanced across participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy M Glaspey, Ph.D., Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075303
- Sponsor's protocol ID
- 186-11
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Assessment of Phonological Disorders: Part 1 Assessment & Part 2 Treatment
- ClinicalTrials.gov ID
- NCT06075303
- Acronym / sponsor ID
- 186-11
- Conditions
- Speech Sound Disorder
- Keywords
- phonology, delay, disorder, speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 4 Oct 2011 (actual)
- Primary completion
- 11 May 2012 (actual)
- Study completion
- 11 May 2012 (actual)
- First posted
- 10 Oct 2023 (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.
The goal of this clinical trial is to learn about (1) how speech skills can be measured and how various tests give speech therapists different types of information for children with speech sound disorder, and (2) whether changes occur in the amount of help children need when they work on easier sounds or harder sounds during treatment. The main questions this study aims to answer are: (1) what does one type of test (dynamic assessment) tell us about speech skills compared to another type of test (static assessment), and (2) does practice of easier or harder sounds show differences in progress. Participants will complete 16 sessions of speech treatment called "modified cycles treatment", and will complete several speech and language tests before, during, and after treatment by pointing to pictures, and saying sounds, words, and sentences.
Detailed description
The Glaspey Dynamic Assessment of Phonology (GDAP) (Glaspey, 2006; Glaspey \& Stoel-Gammon, 2007) was initially developed because children with speech-sound delays make very slow progress in speech therapy and it is difficult to document change in short periods of time using traditional methods of assessment. The traditional methods rely on picture-naming tasks and the child is not given any assistance in speech productions. The lack of assistance often results in a floor effect in the documentation of change and progress. Without good documentation of change, speech-language pathologists are left uncertain about the efficacy of the treatment that they are administering. The GDAP is unique because it assesses change based on dynamic assessment; children are systematically given assistance in the production of speech sounds. When administering the GDAP, clinicians rate each sound on a 15-point ordinal scale that represents the number of cues and assistance that could be used to assist the child in sound production. Progress is documented as children need less support over time and their scores decrease. This study compares the GDAP with a traditional single-word measure. This study also has an extension to use the GDAP to select easier or harder targets during treatment, and monitor children's progress across measures over 8 weeks of modified cycles treatment. The treatment will include 16 sessions of therapy with two 50-minute sessions per week. The treatment approach that will be used is called "Cycles" and involves practicing a different speech sound each week (Rudolf \& Wendt, 2014). The sounds that are practiced will be individualized to each child's needs, with harder sounds taught during four of the weeks and easier sounds taught during four of the weeks. The order will be counter-balanced across participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Children will engage in 4 weeks of treatment on easier targets and 4 weeks of treatment on harder targets. The order (easier first or harder first) will be counterbalanced across participants.
| Arm | Type | Receives |
|---|---|---|
| Easier Targets | Experimental | Behavioral: Modified CyclesAll participants will participate in a modified Cycles approach where speech targets are worked on for a short period of time and switched within a cycle. During the Easier Targets arm, children will work on target sounds that are "easier" based on their pre-treatment scores of 8, 9, 10, or 11 on the Glaspey Dynamic Assessment of Phonology. Children will complete 8 sessions in this arm that are each 50-minutes long and occur two times per week with each target addressed for 2 sessions. |
| Harder Targets | Experimental | Behavioral: Modified CyclesAll participants will participate in a modified Cycles approach where speech targets are worked on for a short period of time and switched within a cycle. During the Harder Targets arm, children will work on target sounds that are "harder" based on their pre-treatment scores of 15, 14, 13, or 12 on the Glaspey Dynamic Assessment of Phonology. Children will complete 8 sessions in this arm that are each 50-minutes long and occur two times per week with each target addressed for 2 sessions. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- monolingual English speakers;
- scores in the mild to profound range for phonological disorder based on the Hodson Assessment of Phonological Patterns (Hodson, 2004);
- scores above 9th percentile on receptive language and cognitive abilities based on measures from the Preschool Language Scale-4 (PLS-4) (Zimmerman, Steiner, \& Pond, 2002) and the Peabody Picture Vocabulary Test (PPVT) (Dunn \& Dunn, 1997);
- perform adequately on a structural-functional examination adapted from the Oral and Speech Motor Control Protocol (Robbins \& Klee, 1987) and Motor Speech Examination (Strand \& McCauley, 1999);
- exhibit voice and fluency skills within normal limits,
Key exclusion criteria (1 listed)
- will not exhibit the prime characteristics of developmental apraxia of speech and/or dysarthria
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 |
|---|---|---|
| Modified Cycles | Behavioural | Easier Targets, Harder Targets |
Primary outcome
Glaspey Dynamic Assessment of Phonology (GDAP)
Time frame: Prior to treatment, after four weeks of treatment, and again after eight weeks.
The GDAP is an evaluation of speech sounds when given help while talking about pictures. The child is asked to say all sounds by themselves, in words, or in sentences. The child is given verbal modeling and instructions to help him/her say the sounds correctly to the highest level possible (i.e. sentences without any model).
1 secondary outcome
Static Assessment of Single Words
Time frame: Prior to treatment, after four weeks of treatment, and again after eight weeks.
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 10 Oct 2023.
- 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.
Amy M Glaspey, Ph.D. principal investigator
University of Montana
Questions about this trial
What is this clinical trial studying?
A study testing Modified Cycles in people with Speech Sound Disorder, run by University of Montana.
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 1 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Glaspey Dynamic Assessment of Phonology (GDAP) (time frame: Prior to treatment, after four weeks of treatment, and again after eight weeks.). 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 10 Oct 2023.