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Behavioral Intervention
ASSIST for Childhood Apraxia of Speech (ASSIST Trial)
Phase 1
Recruiting
Led By Edwin Maas, Ph.D.
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 4;0 and 9;11 (years;months) at enrollment, based on parent report.
Age between 4;0 and 9;11 (years;months) at enrollment, based on parent report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week post treatment
Awards & highlights
ASSIST Trial Summary
This trial is testing a new treatment for childhood apraxia of speech, which is a disorder that impairs the ability to speak clearly. The treatment, called ASSIST, is given in three different doses to see what is most effective. The goal is to improve the child's speech so that they can be more intelligible and participate in communication more.
Who is the study for?
This trial is for English-speaking children aged between 4 and 9 years with Childhood Apraxia of Speech (CAS). They must have a speech sound disorder, be able to speak at least 50 words, show communicative intent, and have normal hearing. Children with significant oral impairments, unrelated health issues that could affect participation, or a primary diagnosis other than CAS are not eligible.Check my eligibility
What is being tested?
The ASSIST program is being tested in this study. It's an intensive speech therapy designed specifically for kids with CAS. The research looks into how effective the treatment is when given over different lengths of time (2 vs. 4 weeks) and using various types of speech targets like simple versus complex sounds or real words against nonwords.See study design
What are the potential side effects?
Since ASSIST is a type of speech therapy intervention rather than a medication, it does not have side effects in the traditional sense. However, participants may experience fatigue from intensive practice or frustration if progress feels slow.
ASSIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 9 years old, according to my parent.
Select...
I am between 4 and 9 years old, according to my parent.
Select...
My speech test scores indicate I have a speech sound disorder.
ASSIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Speech Accuracy of Treated Items
Secondary outcome measures
FOCUS-34 Total Score
ICS Average Score
Speech Accuracy of Untreated Generalization Items
+1 moreASSIST Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Massed ASSISTExperimental Treatment1 Intervention
Study 3
Group II: Distributed ASSISTExperimental Treatment1 Intervention
Study 3
Group III: ASSISTExperimental Treatment1 Intervention
Study 1 and 2
Group IV: Delayed ControlActive Control1 Intervention
Study 1 and 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASSIST
2016
N/A
~20
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Temple UniversityLead Sponsor
297 Previous Clinical Trials
82,553 Total Patients Enrolled
Edwin Maas, Ph.D.Principal InvestigatorTemple University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Three speech experts will watch videos of children speaking and rate if they have certain speech difficulties. If the average rating is above 1, the child will not be included in the study.The main speech issue is Childhood Apraxia of Speech (CAS), determined by specific criteria.You have difficulty sustaining vowel and fricative sounds or repeating syllables quickly during a specific test.Three speech experts will rate if a child has a speech disorder called Childhood Apraxia of Speech based on how they talk and sound. They will use a scale from 0 to 2 to make their judgment.I have been diagnosed with speech difficulties by a speech therapist.You have average nonverbal thinking skills based on a specific test score.You can't hold out sounds or repeat syllables as part of a specific test.You have difficulty speaking clearly, as shown by specific assessment tests.I am between 4 and 9 years old, according to my parent.English is the primary language spoken in my home.The ability to speak at least 50 words and communicate with others, as determined by the clinician and parents.English is the primary language spoken in my home.You have significant problems with the structure of your mouth, as determined by a speech therapist during a mouth exam.I am between 4 and 9 years old, according to my parent.My speech test scores indicate I have a speech sound disorder.I need help with going to the bathroom or can't be away from my parent all day.You can speak at least 50 words and show that you want to communicate, as noticed by the doctor and what your parents say.You have vision problems that might make it hard for you to see and understand the treatment.I have been diagnosed with a condition that affects my communication or social skills.You can hear normally, as reported by your parents or confirmed by a hearing test at different pitches.
Research Study Groups:
This trial has the following groups:- Group 1: ASSIST
- Group 2: Delayed Control
- Group 3: Massed ASSIST
- Group 4: Distributed ASSIST
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research testing allow for elderly participants?
"The age limit for patients in this clinical trial is 9 years old or younger, with a minimum age of 4 years old."
Answered by AI
Has the ASSIST software been cleared by the FDA?
"Since this is only a Phase 1 trial, there is very limited data supporting the safety or efficacy of ASSIST. We have given it a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
< 18
What site did they apply to?
Temple University
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Temple University: < 48 hours
Average response time
- < 2 Days
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