ASSIST for Childhood Apraxia of Speech

(ASSIST Trial)

Overseen By Edwin Maas, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Temple University

Disqualifiers: Autism, Cleft palate, Dysarthria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ASSIST (Apraxia of Speech Systematic Integral Stimulation Treatment) for children with childhood apraxia of speech (CAS), a condition that makes it difficult for kids to articulate words clearly. The study aims to determine the treatment's effectiveness and optimal delivery methods. Researchers are examining various aspects, such as the duration of the treatment and whether focusing on simple or complex words yields better results. Eligible participants have CAS as their primary speech issue and can say at least 50 words. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that ASSIST is likely to be safe for children with childhood apraxia of speech?

Research shows that the ASSIST treatment for childhood apraxia of speech is in the early testing phase. Specific safety data for ASSIST is not yet available, but the main goal of this Phase 1 study is to assess the treatment's safety for children. Phase 1 trials are the first step in testing new treatments in people, with a strong focus on safety. Although detailed safety results for ASSIST are currently unavailable, the study aims to identify any potential issues. Treatments in this phase are closely monitored to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ASSIST for Childhood Apraxia of Speech because it offers a new approach to tackling this challenging speech disorder. Unlike traditional speech therapy that often involves repetitive practice over extended periods, ASSIST utilizes technology to provide targeted, intensive practice. This method aims to enhance neural pathways more effectively, potentially speeding up progress for children. Furthermore, the trial is exploring both massed and distributed practice schedules, which could reveal optimal timing for therapy sessions, making treatment more efficient and personalized.

What evidence suggests that ASSIST might be an effective treatment for childhood apraxia of speech?

Research has shown that ASSIST, a type of speech therapy, may help children with Childhood Apraxia of Speech (CAS). Studies have found that this method can work well for many children with this speech issue. In this trial, participants may receive either the standard ASSIST therapy or variations like Massed ASSIST or Distributed ASSIST, which adjust the intensity and focus of the therapy. Specifically, one study showed that four out of six children made more progress with intensive practice over a short period, suggesting that this approach might be beneficial. While regular speech therapy often leads to slow progress for these children, ASSIST aims to speed up improvements. The treatment remains under investigation, but early results are promising. ^{1 2 3 4 5}

Who Is on the Research Team?

Edwin Maas, Ph.D.

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

I have been diagnosed with speech difficulties by a speech therapist.

Unrelated health concerns that prevent children from participating, per parent report

You have significant problems with the structure of your mouth, as determined by a speech therapist during a mouth exam.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-8 weeks

Treatment Block 1

Children receive intensive ASSIST treatment with 16 hours of individual sessions over two weeks

2 weeks

4 days per week, 8:00 am to 3:00 pm

Treatment Block 2

Continuation of intensive ASSIST treatment with another 16 hours of individual sessions over two weeks

2 weeks

4 days per week, 8:00 am to 3:00 pm

Follow-up

Participants are monitored for changes in speech accuracy and functional outcomes post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• ASSIST

Trial Overview 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.

How Is the Trial Designed?

Group I: Massed ASSIST Experimental Treatment 1 Intervention

Study 3

Group II: Distributed ASSIST Experimental Treatment 1 Intervention

Study 3

Group III: ASSIST Experimental Treatment 1 Intervention

Study 1 and 2

Group IV: Delayed Control Active Control 1 Intervention

Study 1 and 2

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Published Research Related to This Trial

In a study involving 6 children with childhood apraxia of speech (CAS), a higher amount of practice was generally more effective for speech motor learning, with 4 out of 6 children showing better results with increased practice intensity.

Massed practice (intensive practice in a short time) was favored over distributed practice (spreading practice over time) for 4 children, indicating that the way practice is structured can significantly impact treatment outcomes for CAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bang for Your Buck: A Single-Case Experimental Design Study of Practice Amount and Distribution in Treatment for Childhood Apraxia of Speech. Maas, E., Gildersleeve-Neumann, C., Jakielski, K., et al.[2020]

A 3-year-old boy with suspected childhood apraxia of speech showed remarkable improvement in speech after 18 months of intensive therapy, moving from no intelligible speech to age-appropriate articulation.

The early introduction of sign language, combined with structured oro-motor and speech sound therapy, was likely a key factor in his rapid language development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Speech and Language: Using Multimodal Treatment in a Child With Apraxia. Tierney, CD., Pitterle, K., Kurtz, M., et al.[2018]

In a study involving 10 children with childhood apraxia of speech, both motor speech treatment (PROMPT) and language, nonspeech oral motor treatment led to improvements in speech, which were associated with changes in the brain's left ventral corticobulbar tract.

The PROMPT treatment specifically resulted in additional positive changes in the left dorsal corticobulbar tract, suggesting that this multimodal approach may have beneficial neurobiological effects on speech motor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Changes Induced by a Speech Motor Treatment in Childhood Apraxia of Speech: A Case Series. Fiori, S., Pannek, K., Podda, I., et al.[2022]

Children with childhood apraxia of speech (CAS) exhibit significant motor and behavioral problems, with assessments showing that their oral motor functions are notably below average, indicating a potential global motor deficit.

The study of 18 children revealed that many had co-occurring difficulties in overall and manual motor functions and adaptive behavior, suggesting that these issues may contribute to the undiagnosed developmental challenges often seen in CAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor functions and adaptive behaviour in children with childhood apraxia of speech. Tükel, Ş., Björelius, H., Henningsson, G., et al.[2015]

A self-administered computer therapy targeting whole word production significantly improved speech accuracy and fluency in individuals with acquired apraxia of speech over a six-week intervention period.

Participants not only showed immediate improvements in their speech but also maintained these gains after the therapy was withdrawn, indicating the long-term effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Error reduction therapy in reducing struggle and grope behaviours in apraxia of speech. Whiteside, SP., Inglis, AL., Dyson, L., et al.[2016]

The review identified five main tools for assessing childhood apraxia of speech (CAS), including the Verbal Motor Production Assessment for Children and the Kaufman Speech Praxis Test for Children, highlighting the limited options available for accurate diagnosis.

Despite the existence of these assessment tools, there is a lack of comprehensive studies and standardized protocols at the national level, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for the assessment of childhood apraxia of speech. Gubiani, MB., Pagliarin, KC., Keske-Soares, M.[2015]

The Treatment for Establishing Motor Program Organization (TEMPOSM) significantly improved speech skills in children with childhood apraxia of speech (CAS), as evidenced by enhanced acoustic measures and perceptual assessments after four weeks of treatment.

Improvements in speech segmentation, lexical stress, and accuracy were maintained one month after treatment, indicating that TEMPOSM not only helps during therapy but also supports lasting benefits and generalization to untreated speech tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Speech of Children with Apraxia: The Efficacy of Treatment for Establishing Motor Program Organization (TEMPOSM). Miller, HE., Ballard, KJ., Campbell, J., et al.[2021]

In a study involving 4 speakers with chronic apraxia of speech and aphasia, all participants showed improved accuracy in speech production across different treatment intensities and schedules using sound production treatment (SPT).

No significant differences in treatment outcomes were found between the various SPT applications, suggesting that different intensities and practice schedules can be equally effective for improving speech accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for acquired apraxia of speech: examination of treatment intensity and practice schedule. Wambaugh, JL., Nessler, C., Cameron, R., et al.[2016]

The study involved 4 individuals with chronic apraxia of speech (AOS) and aphasia, and it found that using articulatory-kinematic treatment combined with visual biofeedback via electropalatography (EPG) significantly improved the accuracy of speech sounds for most participants.

Participants not only showed improvement in treated speech sounds but also generalized these improvements to untreated phrases, suggesting that EPG could be a promising tool for enhancing speech accuracy in individuals with AOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Electropalatography in the Treatment of Acquired Apraxia of Speech. Mauszycki, SC., Wright, S., Dingus, N., et al.[2018]

A novel speech treatment approach called Autism-Centered Therapy for Childhood Apraxia of Speech (ACT4CAS) was tested on three children with both autism spectrum disorder (ASD) and childhood apraxia of speech (CAS), involving 11-18 treatment sessions.

Results were mixed: one child showed significant improvement in speech production accuracy, while the other two did not demonstrate clear gains, suggesting that treatment intensity and severity of the disorder may affect outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autism-Centered Therapy for Childhood Apraxia of Speech (ACT4CAS): A Single-Case Experimental Design Study. Beiting, M., Maas, E.[2021]

A systematic review of 42 studies on treatments for childhood apraxia of speech (CAS) found that while most children showed positive responses to treatment, only 7 out of 13 approaches demonstrated lasting effects or generalization of improvements.

Three specific treatment approaches—Integral Stimulation/Dynamic Temporal and Tactile Cueing, Rapid Syllable Transition Treatment, and Integrated Phonological Awareness Intervention—showed strong evidence and are recommended for further Phase III trials and clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of treatment outcomes for children with childhood apraxia of speech. Murray, E., McCabe, P., Ballard, KJ.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03903120

ASSIST: Treatment for Childhood Apraxia of Speech This research is a Phase 1 study that tests initial efficacy and optimal parameters of a theoretically based integral stimulation treatment called ASSIST ( ...

2. reporter.nih.gov reporter.nih.gov/search/8CjlEG26Y06CZFKsjhDGUA/project-details/10600110

ASSIST: Child Apraxia Speech Treatment Children with CAS often show little or slow progress in standard speech therapy, which has led to recommendations for intensive intervention and calls for ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2024_JSLHR-23-00233

Treatment for Childhood Apraxia of Speech: Past, Present, ... A wide range of CAS treatments with varying degrees of evidence for efficacy exists. Research is beginning to emerge that compares different treatments.

4. grantome.com grantome.com/grant/NIH/R01-DC017768-01

ASSIST: Child Apraxia Speech Treatment - Edwin Maas The proposed research is a Phase I study that tests initial efficacy and optimal parameters of a theoretically based integral stimulation treatment called ...

5. withpower.com withpower.com/trial/phase-1-apraxias-3-2019-32c43

ASSIST for Childhood Apraxia of Speech (ASSIST Trial) The available research shows that ASSIST, which involves integral stimulation treatment, is effective for most children with Childhood Apraxia of Speech.