Study 5: Effects of Semantic Support
Phase: NA
Conditions: Language Disorders in Children
Sponsor: University of Arizona

Brief Title: Training Grammar With Meaning 
 
 
Unique Protocol ID: DLD-Tx2 
 
ClinicalTrials.gov Identifier: NCT06250101 
 
September 8, 2025 
 
 
 

 
 
1) Study Population 
 
Participants will be between the ages of 4 and 6 years old and have a language 
impairment.  Children will include both boys and girls.  Given that boys are more 
often affected by this condition, we expect a slight excess of boys in the sample 
(e.g. 2:1 m:f).  Subjects will be recruited from Tucson area preschools, 
kindergartens, daycare centers, and treatment programs.  We intend to sample 
from geographic regions that are likely to produce a diversity of racial and ethnic 
backgrounds. 
 
 
We anticipate that up to 300 children will participate over 6 years.  Children will 
reflect all socio-economic levels (as indexed by mother’s/guardian’s educational 
level) with racial and ethnic distribution roughly equivalent to that of the Tucson 
population of children. 
 
 
Power analyses indicate that between 16 and 24 children are required per study 
to find significant effects.  Sample sizes may be adjusted to reflect actual effects as 
studies proceed.  To get these numbers, we typically need to test 50 participants a 
year, with children not meeting the criteria for language impairment, children having 
insufficient numbers of potential treatment targets (speech/language errors) 
withdrawn after testing. 
 
 
Inclusion criteria include: 
Between ages 4 years 0 months and 6 years 11 months at the time of treatment 
onset. 
Native English language development, with exposure to other languages acceptable. 
Normal hearing as indicated by a pure-tone audiometric screening. 
Normal nonverbal skills as indicated by the nonverbal scales of the Kaufman 
Assessment Battery for Children. 
Impaired language as indicated by the Structured Photographic Language Test 
(monolingual English speakers) or the BESA (English/Spanish bilinguals).  
 
 
 
Exclusion criteria include 
Other handicapping conditions that could cause poor language skills (e.g., autism, 
intellectual disability, blindness, genetic disorders, neurologic disease or injury), by 
parent report. 
Native language skills other than English. 
Lack of functional English proficiency by both parents or any guardian.  
 
2) Recruitment Methods and Consenting Process 
a. Recruitment Process:  

1)  Recruitment flyers will be provided through preschools and daycares that include 
children with language impairments.  The flyer is attached. 
2) Parents can contact us directly (e.g., word of mouth referral, response to flyers. 
finding information on their own [e.g., past UA News items].   This item (UA News 
Items) covered only the preschool summer camp program as a community 
engagement piece.  It is not used by us for recruitment, but parents do find it on the 
UA website.   
3) Parents of children on waiting lists from previous years will be phoned to invite their 
child to enroll in the current year (if still age-eligible).   
Parents contacting us through any means will be screened via telephone so that we can 
determine the likelihood of their child qualifying for the study.   
b. Informed Consent:  
A consent form will be used to obtain Parental Permission.  Parents will be provided the 
consent form to read, and the points covered in the written document will be reviewed 
orally with the parents by the project staff (see VOTF).  Parents will have the 
opportunity to ask questions at any time before or after providing consent.  Parents will 
be provided both written and oral notification of major changes to the project (e.g., the 
nature of the treatment procedures used; project location) and oral notifications of 
minor changes (e.g., changes in start date, holidays).  
 
Assent will be waived due to the ages of the children, as children are under the age of 7. 
We are asking for one parental signature. Please see Appendix A.  
The consenting parent must have functional English skills for their child to participate 
[diagnosis of the disorder presumes adequate English exposure].  Therefore, no 
translators or translated documents will be used. 
 
Consent and HIPAA documents are appended. 
 
3) Research procedures involved in the Human Research 
Total participation will last no more than 14 months.  Participant qualification testing 
will occur over 1-4 days (depending on the child’s ability to cooperate) up to 10 
months prior to treatment.  
 Treatment will occur over a 6-week period with daily participation.  Treatment-
related procedures will last up to one hour per day.  In addition to the treatment 
itself, children’s language will be sampled periodically to determine which 
aspects of speech and language are in error and should be treated, as well as to 
track progress.  Testing of verbal and nonverbal characteristics are obtained 
during the treatment period for 15 additional minutes approximately twice a week.  
To facilitate participation of low SES children [whose parents cannot miss work 
for their child’s treatment], all children will be offered supervised day care, 
provided separately from the treatment, for up to 5 hours per day.  Parents are 

asked to return with their children between 2 and 4 months post treatment to 
measure retention of treatment effects.   
This study will compare two variants of the same treatment.  In one, children will be 
told the meaning of verbs that they will be prompted to use along with their 
grammatical target.  In the other, children will not receive information on word 
meanings. 
Treatment sessions will be audio and video recorded.  This will apply to all children 
as a condition of participation.  The recordings are needed to assess accuracy of 
treatment delivery and accuracy of the coding of children’s responses to the 
treatment.  We will request permission to use video recordings for training future 
students and clinicians.  Consent will be indicated by the parent’s initials on a line 
giving this consent on the PHI consent form.  This consent is not required for the 
child to participate. 
Participant qualification testing includes: 
A pure-tone audiometric screening. 
The nonverbal scales of the Kaufman Assessment Battery for Children. materials 
appended 
The Structured Photographic Language Test (monolingual English speakers) or the 
BESA (English/Spanish bilinguals).  materials appended 
 
Treatment methods: 
Treatment methods occur in an adult-child context in which the two are engaged in 
child-appropriate activities (e.g., board games, structured play, book reading, 
craft projects) and conversation.  This treatment is known as Conversational 
Recast which is known to have an overall positive impact on children’s language 
skills, based on published research by our group and others (going back into the 
early 1980s) Clinicians elicit language from the child by prompting them to use 
particular words, phrases, or sentences.  After a child’s response to the 
clinician’s prompt, the clinician provides a correct model of the child’s attempted 
utterance.  Children are provided with at least 24 opportunities per session to 
attempt a treatment target and to receive feedback in the form of a correct 
repetition of the utterance or praise.  No negative feedback is used. 
It is not possible in advance to provide the exact words, phrases, or sentences used 
in treatment for multiple reasons.  First, the linguistic units targeted for treatment 
are tailored to the errors of omission or commission for each individual child 
enrolled.  These are never uniform across all children.  Second, research 
considerations such as balancing particular targets across treatment groups 
influence the decision on what to treat, and therefore, the words used.  Third, the 
treatment is not scripted and should not be scripted (scripted treatments have 
yielded poor effects in the previous literature). Fourth, our previous research has 
found that clinicians must use a large variety of words and contexts to train 
language for it to generalize to new linguistic and environmental contexts.  It is 
not unusual for clinicians to use 75 different activities and well over 200 different 

target words over the course of a treatment period.  Finally, since treatment 
occurs in a conversational context with the child, treatment doses (the words 
spoken to children thought to effect change) often follow from what the child 
says, which is not predictable in advance.   
Sessions are video and audio recorded so that the accuracy of treatment 
administration and coding of child utterances can be checked.  These are used 
so that paper records can be checked for accuracy against a recorded record.  
Entire sessions are never transcribed, although individual words may be when it 
is important to record the exact sounds used in a child’s production (e.g., him vs. 
he; bringed vs. brought, wabbit vs. rabbit). 
 
Analysis plan 
In this study, the dependent variable is expressed as change from baseline performance 
in units of standard deviation. This was designed to address the question of whether the 
treatment produced positive change overall. For this, we consider performance on the 
generalization probes from the first three pretreatment and final three end-treatment probe 
sessions. We calculate a single-subject effect size d metric that reflects gains in morpheme use 
from baseline levels, for each individual child. This is calculated for each of the Target and 
Control morphemes as follows: 
Generalization d = (end treatment probe mean – pretreatment probe mean) 
 
 end treatment standard deviation  
We note that when the end treatment standard deviation was zero, we used the minimum 
possible standard deviation to avoid dividing by zero. We will compare the effect sizes of Target 
morpheme use to Control morpheme use for each group to determine the effects of treatment in 
terms of generalization to untreated words.  
We used a Bayesian statistical approach to data analysis, using JASP software (JASP 
Team, 2021). For all tests, we will use the Bayesian equivalent of a Mann-Whitney U test for 
between group comparisons and a Wilcoxon signed-rank test for within-subject comparisons. 
Bayesian statistics do not require data to meet the assumptions of other parametric tests (e.g., t-
tests), which the types of small samples used in early efficacy studies are unlikely to meet. 
Another important difference is that Bayesian statistics do not test for statistical significance but 
express the probability that two distributions are different. This probability is expressed as a 
Bayes Factor (BF), which can range from 0 to infinity, signaling that probability of a difference is 
highly unlikely to near certainty. A Bayesian approach can also evaluate the probability that two 
distributions are equivalent (1/[BF] for group differences), which is not possible for traditional 
parametric statistics. For tests of within- or between-group differences, this expresses the range 
of effect sizes from within which the true effect is likely to fall.  For correlations (Kendall’s tau 
here), it expresses the range of correlations from which the true correlation is likely to fall.  
As BFs increase above 1.0, support for the experimental hypothesis (e.g., group or 
condition differences) also increases. Guidance on the strength of support was provided by van 
Doorn et al., (2021), who suggested that BFs between 1 and 3 can be interpreted as providing  

weak or incremental support for a hypothesis, moderate support indicated by BFs between 3 and 
10, and strong support for BFs above 10. Although these values were suggested in the context of 
experimental research. We note, however, that comparison of two treatment methods that are each 
known to be efficacious, as will be the case here, is unlikely to result in a BF large enough to meet this 
criterion for  “strong support”. 
To address the effectiveness of the treatment, we will compare the treatment d for 
treated and control grammatical forms, collapsed across treatment conditions.  To address 
whether providing semantic support  improves learning, we will compare the treatment d for 
children who did and did not receive semantic support during treatment. To address the degree to 
which children retained learning after treatment concluded, we correlated (Bayesian Kendall’s 
Tau) the mean performance on the average of the final 3 generalization probes with performance at 
follow-up.