Trial Outcomes & Findings for Treating Childhood Apraxia of Speech (NCT NCT03238677)

Last Updated: 2023-06-22

Results Overview

Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund \& Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

10 weeks from the start of treatment

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Biofeedback, Massed->Distributed, Face-to-Face Sequenced biofeedback Mass Practice--\> Distributed Scheduling Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference. Massed --\> Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment Modality: Face-to-Face	No Biofeedback, Distributed, Face-to-Face Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. Distributed Practice: 2 sessions per week for 10 weeks Modality: Face-to-Face	Biofeedback, Distributed, Face-to-Face Sequenced biofeedback, 2 sessions/wk for 10 weeks Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference. Distributed Practice: 2 sessions per week for 10 weeks Modality: Face-to-Face	No Biofeedback, Massed-> Distributed, Face-to-Face Speech Motor Chaining with no biofeedback. Mass Practice--\> Distributed Scheduling Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html Massed --\> Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment Modality: Face-to-Face	No Biofeeedback, Distributed, Telepractice Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. Distributed Practice: 2 sessions per week for 10 weeks Modality: Telepractice	No Biofeedback, Massed->Distributed, Telepractice Speech Motor Chaining with no biofeedback. Mass Practice--\> Distributed Scheduling Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html Massed --\> Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment Modality: Telepractice
Overall Study STARTED	9	9	10	9	10	9
Overall Study COMPLETED	7	7	8	8	9	9
Overall Study NOT COMPLETED	2	2	2	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant withdrew after randomization but before baseline collection of this datapoint

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofeedback, Massed->Distributed, Face-to-Face n=9 Participants Sequenced biofeedback Mass Practice--\> Distributed Scheduling Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference. Massed --\> Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment Modality: Face-to-Face	No Biofeedback, Distributed, Face-to-Face n=9 Participants Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. Distributed Practice: 2 sessions per week for 10 weeks Modality: Face-to-Face	Biofeedback, Distributed, Face-to-Face n=10 Participants Sequenced biofeedback, 2 sessions/wk for 10 weeks Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference. Distributed Practice: 2 sessions per week for 10 weeks Modality: Face-to-Face	No Biofeedback, Massed-> Distributed, Face-to-Face n=9 Participants Speech Motor Chaining with no biofeedback. Mass Practice--\> Distributed Scheduling Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html Massed --\> Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment Modality: Face-to-Face	No Biofeeedback, Distributed, Telepractice n=10 Participants Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. Distributed Practice: 2 sessions per week for 10 weeks Modality: Telepractice	No Biofeedback, Massed->Distributed, Telepractice n=9 Participants Speech Motor Chaining with no biofeedback. Mass Practice--\> Distributed Scheduling Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html Massed --\> Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment Modality: Telepractice	Total n=56 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=9 Participants	1 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	1 Participants n=56 Participants
Age, Continuous	10.31 years STANDARD_DEVIATION 1.0 • n=9 Participants	10.85 years STANDARD_DEVIATION 1.7 • n=9 Participants	12.2 years STANDARD_DEVIATION 2.1 • n=10 Participants	10.0 years STANDARD_DEVIATION 1.1 • n=9 Participants	11.05 years STANDARD_DEVIATION 2.4 • n=10 Participants	11.16 years STANDARD_DEVIATION 2.3 • n=9 Participants	10.96 years STANDARD_DEVIATION 1.9 • n=56 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	3 Participants n=9 Participants	2 Participants n=10 Participants	3 Participants n=9 Participants	4 Participants n=10 Participants	2 Participants n=9 Participants	17 Participants n=56 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	6 Participants n=9 Participants	8 Participants n=10 Participants	6 Participants n=9 Participants	6 Participants n=10 Participants	7 Participants n=9 Participants	39 Participants n=56 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=9 Participants	1 Participants n=9 Participants	2 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	3 Participants n=9 Participants	9 Participants n=56 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=9 Participants	8 Participants n=9 Participants	8 Participants n=10 Participants	9 Participants n=9 Participants	9 Participants n=10 Participants	6 Participants n=9 Participants	46 Participants n=56 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	1 Participants n=10 Participants	0 Participants n=9 Participants	1 Participants n=56 Participants
Race (NIH/OMB) White	9 Participants n=9 Participants	8 Participants n=9 Participants	8 Participants n=10 Participants	7 Participants n=9 Participants	6 Participants n=10 Participants	7 Participants n=9 Participants	45 Participants n=56 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=10 Participants	2 Participants n=9 Participants	3 Participants n=10 Participants	2 Participants n=9 Participants	9 Participants n=56 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=10 Participants	0 Participants n=9 Participants	1 Participants n=10 Participants	0 Participants n=9 Participants	1 Participants n=56 Participants
Region of Enrollment United States	9 participants n=9 Participants	9 participants n=9 Participants	10 participants n=10 Participants	9 participants n=9 Participants	10 participants n=10 Participants	9 participants n=9 Participants	56 participants n=56 Participants
Speech Sound Accuracy	20.2 Percent correct STANDARD_DEVIATION 7.3 • n=9 Participants • Participant withdrew after randomization but before baseline collection of this datapoint	21.2 Percent correct STANDARD_DEVIATION 12.1 • n=9 Participants • Participant withdrew after randomization but before baseline collection of this datapoint	17.0 Percent correct STANDARD_DEVIATION 4.3 • n=10 Participants • Participant withdrew after randomization but before baseline collection of this datapoint	23.2 Percent correct STANDARD_DEVIATION 7.4 • n=8 Participants • Participant withdrew after randomization but before baseline collection of this datapoint	28.9 Percent correct STANDARD_DEVIATION 8.1 • n=10 Participants • Participant withdrew after randomization but before baseline collection of this datapoint	35.5 Percent correct STANDARD_DEVIATION 7.8 • n=9 Participants • Participant withdrew after randomization but before baseline collection of this datapoint	24.3 Percent correct STANDARD_DEVIATION 7.8 • n=55 Participants • Participant withdrew after randomization but before baseline collection of this datapoint

PRIMARY outcome

Timeframe: 10 weeks from the start of treatment