NCT06504264

Brief Summary

This study will use an experimental design to explore if articulatory gestures (with letters and phonemic awareness training) enhance early literacy skills more than general mouth awareness training (with letters and phonemic awareness training) or letter/phonemic awareness training alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 3, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

July 3, 2024

Last Update Submit

September 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of words correctly phonemically segmented from primary investigator created list

    will tell the sounds in 9 words presented orally

    immediately after the intervention

Secondary Outcomes (2)

  • number of words read correctly from primary investigator created list

    immediately after the intervention

  • number of nonwords read correctly from primary investigator created list

    immediately after the intervention

Study Arms (3)

LPA: Letters-phonemes-articulatory gestures

EXPERIMENTAL

This group will receive training for phonemic segmentation that includes using printed letters, sounds (phonemes) while simultaneously learning the articulation placements of the letters/sounds.

Behavioral: phonemic segmentation

LPM: Letters-phonemes-general mouth awareness

EXPERIMENTAL

This group will receive training for phonemic segmentation that includes using printed letters, sounds (phonemes) while simultaneously learning about the mouth in general.

Behavioral: phonemic segmentation

LP: Letters-phonemes

EXPERIMENTAL

This group will receive training for phonemic segmentation that includes using printed letters and sounds (phonemes) only.

Behavioral: phonemic segmentation

Interventions

during phonemic segmentation activities, articulatory gestures will be used while teaching letters and their sounds.

LP: Letters-phonemesLPA: Letters-phonemes-articulatory gesturesLPM: Letters-phonemes-general mouth awareness

Eligibility Criteria

Age48 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Knows 15 letter names
  • Passes hearing screening
  • Passes Fluharty-2 Language Screening
  • Can segment no more than three consonant-vowel (CV), VC, or CVC words into phonemes
  • Not able to read more than one word or nonword used in the posttest.

You may not qualify if:

  • Does not know 15 letter names
  • Fails hearing screening
  • Fails Fluharty-2 Language Screening
  • Can segment more than three consonant-vowel (CV), VC, or CVC words into phonemes
  • Reads more than one word or nonword used in the posttest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montclair State University

Montclair, New Jersey, 07043, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Robyn Becker

    Montclair State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 16, 2024

Study Start

September 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations