Clinical trial NCT05921227: Addressing Treatment Nonresponders
Official title: Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Language Development Disorders
Keywords: Late Talkers
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All participants will start in the traditional Vocabulary Acquisition and Usage for Late Talkers (VAULT) model. Those who do not respond to treatment early on will be moved to the Augmentative and Alternative Communication Device arm of the treatment.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.

Detailed description: Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.

Eligibility criteria: Inclusion Criteria:

* Native English Speaking
* Pass pure tone hearing screening or medical report of normal hearing
* 2-3 years at start of study
* MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale \<10th percentile

Exclusion Criteria:

* Parental report of other diagnoses
* Enrolled in concurrent treatment elsewhere
* Nonverbal IQ \<75 as measured by the Bayley Scales
* Parents unable to consistently bring child to treatment sessions.

Primary outcomes:
measure: Treatment Effect Size
timeFrame: Change from baseline through treatment, which will average an 8-week time frame.
measure: Number/Rate of words learned
timeFrame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary outcomes:
measure: Post Treatment Retention
timeFrame: Change from end of treatment to follow up, which will average 4-6 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Mary Alt, PhD
role: PRINCIPAL_INVESTIGATOR
References: