Dynamic Assessment of Phonological Disorders

October 3, 2023 updated by: University of Montana

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • will not exhibit the prime characteristics of developmental apraxia of speech and/or dysarthria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Easier Targets
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.
Behavioral: Modified Cycles
Experimental: Harder Targets
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.
Behavioral: Modified Cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Prior to treatment, after four weeks of treatment, and again after eight weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Static Assessment of Single Words
Time Frame: Prior to treatment, after four weeks of treatment, and again after eight weeks.
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.
Prior to treatment, after four weeks of treatment, and again after eight weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Montana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy M Glaspey, Ph.D., University of Montana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 186-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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