Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05277103 |
| Other study ID # |
STUDY00147284 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2021 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of Kansas Medical Center |
| Contact |
Kathy Thiemann-Bourque, PhD |
| Phone |
913-897-8445 |
| Email |
thiemann[@]ku.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will examine what child variables (i.e., social attention and peer interest)
predict communication gains in response to a peer-mediated intervention for 40
minimally-verbal preschool children with ASD and 80 peers. The Stay-Play-Talk with iPad
intervention will be implemented for 8 weeks. Gains in communication and reciprocity with
peers will be measured at post-treatment and in non-treatment settings. Another goal is to
determine if variance in communication gains accounted for by the two social variables
differs based on the pre-treatment measurement context.
Description:
Overview. This project will use a single group pre-post treatment design across four
independent cohorts of children (n=8, 10, 11, and 11 per cohort). This design is appropriate
because the purpose of this study is to examine predictors of treatment response and the
intervention's efficacy has been documented in an RCT.
Research Team. Dr. Bourque (PI) was the lead investigator on a NIH funded R01, examining a
peer-mediated SGD intervention for preschoolers with ASD, Co-PI of a RCT peer network
intervention for elementary-age students with ASD (IES), and Co-PI of two NIH grants (R01,
P01) to assess communication development of preschoolers with ASD/IDD using AAC. She has
almost 20 years of established relationships with local districts recruiting participants,
Dr. Boyd is PI of a NIH funded R01 grant focused on outcome measure development for children
with ASD, and Co-I of an R01 focused on predictors of treatment response for children with
ASD. Dr. Salley has extensive experience developing eye-tracking (ET) and bio-behavioral
attention measures with infants/toddlers and is PI of a longitudinal study examining the
development of early social/nonsocial attention (NIH). Dr. Fleming is Director of the
Research Design and Analysis Unit in the Life Span Institute. She has participated as a
quantitative methodologist on 38 NIH and USDE-supported grants. Consultants to the team bring
specialized expertise: (1) Dr. Shic has contributed to the design of 50 ET paradigms and 6000
recorded eye tracking datasets, the majority at-risk for or diagnosed with ASD, and is thus
well-prepared to provide guidance in ET methodology and analysis; (2) Dr. McPartland is PI of
the NIH-funded Autism Biomarker Consortium for Clinical Trials, a large scale effort to
evaluate the utility of ET and EEG biomarkers in ASD. He will assist in administration of ET
paradigms and in data acquisition.
Sample and Recruitment. A total of N=40 children between the ages of 3-6 years will
participate, with n=18 recruited in Year 1 (Cohort 1=8; Cohort 2=10) and n=22 in Year 2
(Cohort 3=11; Cohort 4=11). Participants will attend preschool with access to typically
developing peers. ASD diagnosis will be confirmed by the Autism Diagnostic Observation
Scale-2 and DSM-V criteria, with minimal verbal skills defined as less than 20 spontaneous
words or symbols. Each child will demonstrate symbol discrimination skills by intentionally
selecting preferred items in 80% of trials in two 1:1 adult sessions using a
matching-to-sample procedure; children who do not meet this criteria will be excluded due to
insufficient skills to benefit from SGD intervention. Recruitment will occur in local
preschools and the Kansas Center for Autism Research and Training registry, which contains
3000+ families, with approximately 65% individuals with ASD. The investigators are confident
they can recruit 40 children given the gradual recruitment plan in Year 1 and the teams
established relationships with administrators. Two peers without disabilities from the same
classroom (or school building) will be recruited for each child with ASD (n=36 peers Year 1;
44 Year 2; N=80 total). Teachers will recommend peers who meet a minimum 6 of 8 behavioral
characteristics related to peer social responsiveness and fidelity in the prior RCT.
Pre-Treatment Standardized Measures. Three standardized measures will be administered at
enrollment: (1) the Preschool-Language Scale-5 to describe children's expressive language and
auditory comprehension skills, (2) the Early Years Battery of the Differential Ability
Scales-II to assess cognitive abilities across verbal, nonverbal reasoning, and spatial
clusters, and (3) the Vineland Adaptive Behavior Scales III-Parent Interview to describe
communication and adaptive skills. Child language and cognitive scores will be used as
indicators of global child characteristics and added as covariates to analytic models. All
standardized tests and social variable measures will be administered by research staff naive
to study hypotheses.
Measurement Contexts. Social attention and peer interest will be measured in three contexts
at one time point, prior to the start of treatment: (1) semi-structured peer communication
sample, (2) naturalistic observations, and (3) eye-tracking (ET) paradigms. The SGD will be
available during contexts (1) and (2), and during breaks in context (3). The first context
was used in the PIs R01 to measure communication and joint attention between children with
ASD and peers; thus, the administration manual and reliability procedures already exist. In
this study, codes will be modified to collect social attention and peer interest data. The PI
has extensive experience developing direct observation coding systems and training staff to
be reliable in collecting multifaceted communication and social behavior data for this
population. Along with Dr. Salley's ET experience, our team is confident that collecting
reliable data across the three planned contexts is feasible.
1. Semi-Structured Peer Communication Sample: This will be administered at school, in a
quiet room with the focal child and one peer; total assessment time is 25-35 min for 12
scripted activities (2-3min/task). The PI will train the examiner to administer the
assessment to fidelity (i.e., 80% of steps, see Appendix A) across three practice
sessions. The 12 scripts create opportunities for the child to communicate following
peer presentation of each task (e.g., give bubbles with lid glued on). Coding of the two
social behaviors will occur within a 1-minute start-stop window immediately after peer
presentation of each task (total coding time 12 minutes).
2. Naturalistic Observations: Three preschool contexts will be observed for 10 min each
over one day, for a total of 30 min. We include multiple observations during
naturalistic settings that provide different communication opportunities. To provide
consistency across classrooms and opportunities for the child to engage with adults
and/or peers, the three contexts will be (1) snack with an adult present, (2) free play
that includes only children, and (3) a small group learning activity with both peers and
adults.
3. Eye-tracking Paradigms/Method: Eye tracking measures will be collected at Dr. Salley's
Child Development Lab using the Tobii TX300 which has been used extensively with young
children with ASD because it is non-invasive (no equipment attached to child) and robust
to head movements. This desktop-mounted system records eye movements while subjects view
scenes on a 17 inch monitor. Children will participate in three well-established
eye-tracking tasks shown to be sensitive to individual differences and used successfully
with children with ASD of varying severity levels. The Static Visual Exploration Task
consists of 12 picture arrays of 12 people (adults; children) and/or objects (half are
objects and smiling faces; half are object only), presented for 10 sec each in fixed
order (approx. 5 min total). The Dynamic Visual Exploration Task consists of 12 silent
video arrays of objects and people (adults), with each array including four videos
playing concurrently in each quadrant of the screen, with face and object locations
pseudorandomized (approx. 4 min). The study team will adapt this task to incorporate
videos of child emotions faces, in addition to the existing adult emotion faces. The
Interactive Visual Exploration Task consists of 22 silent naturalistic videos of pairs
of children engaging in cooperative and parallel play with objects (including episodes
of social communication) in various settings, presented for 15 sec each in fixed order
(approx. 5.5 min total).
Social Variable Measures. At pre-treatment, all social variables will be live coded using
Pocket Observer installed on tablets. Data will be uploaded to Noldus Observer XT projects on
a lab computer for analysis and secondary coding. Research staff will be trained to a
criterion of 80% inter-rater reliability on all social behaviors (see Appendix B) over three
sessions using recordings of child social interactions from the PIs R01.
Social attention: For the semi-structured (12 min total) and naturalistic assessments (30 min
total), social attention will be (a) total % of time child visually attends to the peer's
face, and (b) total % of time child visually attends to the adult's face. For eye tracking
assessments, social attention will be total % time child visually attends to adult and peer
faces in the Static and Dynamic Visual Exploration Tasks.
Peer interest: For semi-structured and naturalistic assessments, peer interest will be total
rates of (a) child joint attention to peer actions/activities, by looking at the object being
acted on then to peer's face within 5 sec, and (b) child imitation of peer actions/activities
within 5 sec. For eye tracking assessments, peer interest will be total % time child visually
attends to peer faces and activities during the Interactive Visual Exploration Task.
Baseline and Intervention Outcome Measures. The two primary measures to be collected during
baseline and at 8 weeks post start of treatment are: (1) total rate of spontaneous child
intentional communication acts, and (2) total rate of reciprocal child-peer exchanges. The
time frame was selected based on clear gains observed over the first 8 weeks of treatment in
the previous R01 (see Figure 1). For each measure, total frequency will be obtained across
three 10-min sessions at each time point (total 30 min pre- and post-), with total acts then
averaged across the three sessions and converted to a rate per minute. Change in each rate
will be used in the analyses. Intentional acts are defined as the use of any communicative
mode (e.g., gestures, speech, SGD) that are clearly directed to a peer using eye contact/body
orientation to communicate for a functional purpose (e.g., request objects/actions, comment,
or protest). Each intentional act will be coded as an initiation (IN) or response (RS), with
RSs coded within 5 sec of the other child's act. If 5 sec pass without a RS, the next act
will be coded as a new IN. Each IN + RS sequence between child and peer is coded as one
reciprocal exchange; longer IN + RS exchanges are possible if a child continues to respond
within 5 sec (i.e., IN + RS + RS + RS - 5 sec pause - IN + RS). This coding system is based
on the PIs published studies.
Generalization Outcome Measure. At baseline and 8 weeks post start of treatment, when
intervention outcome data are collected, rates of the two dependent variables (i.e.,
spontaneous intentional child communication acts and reciprocal acts) will be coded for 10
min in two non-intervention settings (total 20 min): snack and free-play. Total rate for each
variable will be averaged across the 20 minutes and change in each rate from pre- to
post-generalization probes will be used in the analyses.
Baseline Procedures. Prior to treatment, one child-peer dyad will be seated at a table and
engage in three 10-min social activities commonly observed in preschool (e.g., matching
games, puzzles). Children will be instructed to stay together and play, with the SGD (iPad)
programmed to match the activity. No adult prompts will be provided. The two peers recruited
for each child with ASD will participate on a rotating schedule.
Intervention Procedures. Four cohorts of children will receive the intervention in two 30-min
weekly sessions for 8 weeks, with one cohort starting in the fall and one in the winter of
each study year (n=18 Yr 1; n=22 Yr 2). To feasibly intervene with four cohorts, the PI will
train research staff to provide the intervention. Using training materials developed in her
R01, staff will be trained to 90% fidelity of 10 steps. We will track concurrent speech
language therapy, ABA therapy, and other therapies received within and outside of school.
SGD Setup and Familiarity. All children will receive an iPad with Touch Chat app as a SGD to
use for the duration of the study. We will recommend all children have SGD access across
their school day. School and home SGD usage will be monitored with automated data logging
software installed on each iPad.
Peer Training. Peers will be trained in three 30-min sessions following the Stay-Play-Talk
with iPad approach from the PIs earlier AAC studies. Each step is taught using a standard
protocol of discussion, modeling, practice, and feedback focusing on: (1) Stay (Sit Close; If
Buddy Moves you Move), (2) Play (Share Toys; Take Turns), and (3) Talk with iPad (Look and
Listen; Push and Talk), and one added step found to increase child responses (4) Get
Attention and Hold and Wait. The peer creates an expectant pause for the focal child to
communicate by gaining attention, holding an object (out of reach) and waiting.
Direct SGD Instruction with Trained Peer. Each peer will engage in a 15-min activity on a
rotating basis. The first 5 min focuses on Stay-Play-Talk skill review, child-peer practice
using the iPad and adult feedback. In the next 10 min, the implementer observes the
children's interactions and as necessary provides prompts with a least-to-most hierarchy for
successful communication exchanges. That is, peers are prompted to model SGD use and help the
child push a symbol prior to the adult eliciting child communication. Sessions will be
provided twice per week for 8 weeks, a sufficient length of time for intervention response to
occur (see Figure 1).
Fidelity Procedures. Two forms will be used to monitor fidelity of adult administration to:
(1) coach peers in the pre-treatment semi-structured assessment, and (2) implement twice
weekly PMI + SGD treatment. To monitor adherence to the treatment protocol and identify peers
who may need more support, peer treatment fidelity will be collected for 30% of sessions. If
a peer falls below 60% fidelity over two sessions, a 20-min refresher session will be
provided. Mean fidelity of peer implementation in the R01 was 80% for all trained peers, and
retraining was necessary with only three peers (5% of total).
Data Analysis. Initial analyses will examine the distributions of the two change in rate
variable outcomes, and if necessary, generalized linear models with appropriate link
functions will be employed. Initial analyses will examine cohort effects, although no
differences are expected. For each aim separate models will be examined for the change in
child communication rate and change in rate of reciprocal exchanges. Because of the
relatively small sample, limited sets of predictors will be examined in each model. For Aim
1a, separate regression models will be used to determine the relative strength of association
and predictive value of each pair of social variables for response to intervention. PLS-5 and
DAS-II scores will be entered as covariates into all models because of demonstrated
associations between language skills and cognitive abilities and communication outcomes. For
example, rate of joint attention and rate of imitation in naturalistic observations will be
examined together as indicators of peer interest. Pseudo-R2 values will be compared across
the 6 models (peer interest and social attention for each assessment context) for each
outcome to identify which social predictors account for the most variance in communication
gains. To determine the effect of measurement context on the strength of relationship between
social predictors and outcomes (Aim 1b), the two social attention and two peer interest
variables from the same context will be examined together but without additional covariates
because of the limited sample size. Pseudo-R2 values will be used to descriptively compare
the contexts to determine which predictors account for the most variance in intervention
outcomes. Multiple imputation or FIML estimation will be used to bring exogenous variables
into the likelihood function and account for missing data in both Aim 1a and Aim 1b although
missing data was minimal in the PIs previous trial. Parallel analyses will be conducted to
determine if social variables predict the two generalized communication outcomes (Aim 2a).
Communication outcomes will come from peer interactions in non-treatment settings, but the
predictors and approach will be the same as in Aim 1. Similarly, the analyses for Aim 2b will
follow the process described for Aim 1b.
Sex as a Biological Variable. Because the sample is likely to be predominantly male due to
the gender composition of individuals with ASD, it will not be possible to evaluate sex
differences in these effects. The investigators will present results for the total sample,
male subgroup, and female subgroup when possible.
Power. With the proposed sample of 40 participants, the investigators will have .80 power to
detect moderate associations between social variables and outcomes (f2=.21) in Aims 1a and
1b. For Aim 1b and 2b, we will have .80 power to detect moderate effects of f2=.26.
