Health TrialsbyHealthPanel

Addressing Treatment Nonresponders

ConditionLanguage Development Disorders
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-4
SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VAULT Phase 6

    Behavioral

    VAULT is an input-based word learning intervention based on principles of statistical learning.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Alternative Treatment Including Augmentative and Alternative CommunicationExperimental treatment 1 intervention
Group B: Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Effect Size

The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).

Time frame
Change from baseline through treatment, which will average an 8-week time frame.
2

Number/Rate of words learned

The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment and measured during, immediately following, and 4-6 weeks after the treatment.

Time frame
Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.

Secondary outcomes

1

Post Treatment Retention

We will use probe data or specific words and parental report to determine how many of the words the child retained from treatment.

Time frame
Change from end of treatment to follow up, which will average 4-6 weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: