Pediatric Speech Therapy Session Frequency and Speech Outcomes

NCT05900180 | Completed

• 1 other identifier: 22-160
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Examination of frequency of therapy and effect on clinical outcomes.

Conditions

Speech Therapy; Pediatric; Language Disorders in Children; Articulation Disorders in Children; Communication Disorder, Childhood; Mode of Therapy; Frequency of Therapy

Outcome Measures

Primary Outcomes (4)

• Change in Articulation and intelligibility

  Scores on the following standardized measures: Goldman Fristoe Test of Articulation- Third Edition (GFTA-3) ; Average Standard Score range is from 86-114; an increase in standard score indicates improvement in intelligibility.

  Baseline, immediately after treatment (up to 4 months)

• Change in Receptive vocabulary skills

  Scores on the following standardized measure: Receptive One Word Picture Vocabulary Test- Fourth Edition (ROVPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding vocabulary.

  Baseline, immediately after treatment (up to 4 months)

• Change in Expressive vocabulary skills

  Scores on the following standardized measure: Expressive One Word Picture Vocabulary Test- Fourth Edition (EOWPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding or labeling vocabulary.

  Baseline, immediately after treatment (up to 4 months)

• Change in Receptive and expressive early language skills

  Scores on the following standardized measures: Receptive-Expressive Emergent Language Scale- Fourth Edition (REEL-4); Average Standard Score range is from 90-109; an increase in standard score indicates improvement in language ability score.

  Baseline, immediately after treatment (up to 4 months)

Secondary Outcomes (1)

• Home Exercise Plan (HEP) provision

  up to 4 months

Study Arms (2)

Every-other-week therapy with home programming

ACTIVE COMPARATOR

Receipt of standard speech therapy care (every-other-week) for 8.0 sessions

Behavioral: Speech Therapy

Weekly therapy with home programming

EXPERIMENTAL

Receipt of speech therapy care (every week) for 8.0 sessions

Behavioral: Speech Therapy

Interventions

Speech Therapy BEHAVIORAL

Delivery of speech therapy services

Every-other-week therapy with home programming; Weekly therapy with home programming

Eligibility Criteria

• Age: 18 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medical order for speech therapy
• Patients eligible for speech therapy at Connecticut Children's (qualify for receptive, expressive language and/or articulation therapy)
• Diagnosis of communication disorder.ICD-10 codes will be utilized pertaining to expressive, receptive language and articulation disorders (ICD-10 code specific to patient: F80.0, F80.1, F80.2, F80.4, F80.9, R47.89, R41.841)
• Patient recommended for individual (i.e. not group) treatment
• months to 16 years of age
• Completed 1 plan of care (POC) with a duration of 8 sessions
• Attended at least 80% of scheduled visits during their plan of care period (still completing 8 sessions of therapy, may have extended time to completion).
• Services for a full 8-session plan of care.

You may not qualify if:

• \- Seeking speech therapy care for treatment of disorders related to diagnosis of voice, feeding, fluency, and/or cognition
• Patient unable to complete standardized tests (EOWPVT-4, ROWPVT-4, GFTA-3, REEL-4)
• Patients in group speech therapy
• Patients younger than 18 months or older than 16 years of age
• Not willing to complete a full POC (8 sessions)
• Unable/unwilling to attend 80% of scheduled visits

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• Van Epps VM, Daur-Schierholz M, Dortenzio M, Mendillo E, Urzua J, Brimacombe M, Hinderer KA. How changes to frequency of treatment and mode of treatment improved paediatric speech-language pathology services: A pragmatic clinical trial. Int J Speech Lang Pathol. 2026 Mar 8:1-12. doi: 10.1080/17549507.2026.2630835. Online ahead of print.

  PMID: 41795638 RESULT

MeSH Terms

Conditions

Communication Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Virginia Van Epps, M.Ed.

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

• Mary Dortenzio, MS

  Connecticut Children's Medical Center

  STUDY DIRECTOR

• Jodi Urzua, MS

  Connecticut Children's Medical Center

  STUDY DIRECTOR

• Emma Mendillo, MA

  Connecticut Children's Medical Center

  STUDY DIRECTOR

• Morgan Daur-Schierholz, MS

  Connecticut Children's Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: June 12, 2023
• Study Start: January 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)