NCT06075303

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2012

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 3, 2023

Last Update Submit

October 3, 2023

Conditions

Keywords

phonology, delay, disorder, speech

Outcome Measures

Primary Outcomes (1)

  • 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).

    Prior to treatment, after four weeks of treatment, and again after eight weeks.

Secondary Outcomes (1)

  • Static Assessment of Single Words

    Prior to treatment, after four weeks of treatment, and again after eight weeks.

Study Arms (2)

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.

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.

Behavioral: Modified Cycles

Interventions

Modified CyclesBEHAVIORAL
Easier TargetsHarder Targets

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Speech Sound DisorderSpeech

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Study Officials

  • Amy M Glaspey, Ph.D.

    University of Montana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participating children will not be aware of the targets identified as "easier" or "harder"
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

October 4, 2011

Primary Completion

May 11, 2012

Study Completion

May 11, 2012

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share