Journal of Autism and Developmental Disorders

https://doi.org/10.1007/s10803-018-03872-3

BRIEF REPORT

Brief Report: Feasibility and Preliminary Efficacy of a Behavioral

Intervention for Minimally Verbal Girls with Autism Spectrum Disorder
Tom Cariveau1 · M. Alice Shillingsburg2 · Arwa Alamoudi3 · Taylor Thompson4 · Brittany Bartlett4 · Scott Gillespie4,5 ·
Lawrence Scahill4,5

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Abstract
We report the feasibility and preliminary efficacy of a structured behavioral intervention with a sample of minimally verbal
girls with autism spectrum disorder between the ages of 2 and 6 years old. Ten participants with no functional vocal behavior
were randomized to a 4-week behavioral intervention or waitlist control group. Caregivers reported child communicative
repertoires at pre- and post-randomization assessments. Social communication was also assessed at these time points using
the Early Social Communication Scales. All feasibility benchmarks were met and findings of preliminary efficacy showed
large effect sizes within groups. The current findings suggest the feasibility of recruiting and retaining samples of young,
minimally verbal girls with autism spectrum disorder in randomized clinical trials.

Keywords Feasibility · Female · Intervention · Minimally verbal · Sex differences

Autism spectrum disorder (ASD) is defined by early child-
hood onset of social communication deficits, restricted inter-
ests and repetitive behavior (American Psychiatric Associa-
tion 2013). The Centers for Disease Control and Prevention
(2018) estimate that ASD affects 15 per 1000 children in
the US with a four- to fivefold higher prevalence in boys
compared to girls. Approximately a third of children with
ASD have an intellectual disability. Interest in sex differ-
ences in ASD is longstanding, although attempts to identify
Electronic supplementary material The online version of this
article (https​://doi.org/10.1007/s1080​3-018-03872​-3) contains
supplementary material, which is available to authorized users.
* Tom Cariveau
cariveaut@uncw.edu
1
University of North Carolina Wilmington, 601 S. College
Rd, Wilmington, NC 28304, USA
2
The May Institute, 41 Pacella Park Dr., Randolph,
MA 02368, USA
3
University of Georgia, 110 Carlton St., Athens, GA 30602,
USA
4
Marcus Autism Center, 1920 Briarcliff Rd NE, Atlanta,
GA 30329, USA
5
Emory University School of Medicine, 1648 Pierce Dr NE,
Atlanta, GA 30307, USA
sex differences have provided inconsistent results (Frazier
et al. 2014; Howe et al. 2015).
The four- to five-fold male to female ratio is also observed
in multisite medication and behavioral intervention trials
(Cariveau et al. submitted; Reichow 2011). The low repre-
sentation of girls with ASD in intervention research leaves
open whether empirically supported treatments in boys are
equally effective in girls. To answer this question, further
study is needed in samples enriched with girls.
In this pilot study, we focus on young girls with ASD
without any meaningful language. Despite some differences
in the definition, children with ASD without meaningful
speech beyond rote phrases are commonly classified as
“minimally verbal” (Kasari et al. 2013). This subgroup may
include as many as 25–30% of children with ASD (Anderson
et al. 2007; Norrelgen et al. 2015). Minimally verbal girls
with ASD have been under-represented in studies of inten-
sive behavioral interventions (see Reichow 2011). Thus, the
evidence supporting behavioral interventions for minimally
verbal girls with ASD is extremely limited and research in
this group is overdue. The primary aim of this study was to
demonstrate the feasibility of conducting a brief randomized
behavioral intervention with minimally verbal girls with
ASD in advance of a larger randomized trial. Feasibility
benchmarks set a priori included accrual, attrition, attend-
ance, data collection, and treatment fidelity. The secondary

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 Journal of Autism and Developmental Disorders

aim was to evaluate the preliminary efficacy of a behavioral Intervention

intervention previously untested in girls.
The structured protocol was delivered by a trained therapist
to promote the child’s social approach behaviors and reduce
social avoidant behaviors (Shillingsburg et al. 2014). Social
Methods
approach behaviors included remaining in close proximity to
the therapist (i.e., within 0.66 m), approaching the therapist,
Participants
and compliance with instructions. Social avoidant behaviors
included negative vocalizations (e.g., crying or screaming)
Participants were recruited via posted fliers and referrals
and disruptive behaviors (e.g., throwing items, aggression,
from research or clinical departments in a large clinical
and self-injurious behavior). Participants were allowed to
program and research center in the southeastern United
move freely throughout the room; however, access to the
States. To be eligible, girls had to meet criteria for ASD,
therapist’s attention and preferred items was only provided
be between 24 and 71 months of age, and have fewer than
in response to social approach behaviors. The structured
five words. The diagnosis of ASD was made by expert clini-
intervention included eight stages (see Shillingsburg et al.
cians at the center based on clinical judgment and supported
2018). Progression through each stage was based on prede-
by the Autism Diagnostic Observation Schedule – Generic
termined criteria of social approach and avoidant behaviors.
(ADOS-G; Lord et al. 2000). The assessment battery also
Initially, the child received noncontingent access to preferred
included the Vineland-II (Sparrow et al. 2005) and Mullen
items and interaction by the therapist. Once social approach
Scales of Early Learning (Mullen 1995).
behaviors began to emerge, instructional demands were sys-
The determination of fewer than five words was based
tematically introduced so that early skill repertoires could be
on caregiver report, observations during the ADOS-G, the
targeted. The final stage of this protocol included high rates
Early Social Communication Scales (see below), and direct
of instructional demands (i.e., an average of three demands
assessment during the screening visit. During the direct
followed by a 15-s break) without requiring additional
assessment, participants had access to toys for 10 min to
behavior management procedures. Progression through the
observe spontaneous communication. This was followed by
protocol occurred when social approach behaviors were
twenty therapist-guided opportunities for the child to request
observed during the majority of the instructional session,
a preferred item.
thus the final phase included fast-paced instruction, without
the need for behavior management procedures.
Design
Feasibility Measures
Eligible subjects were randomly assigned to 16 2-h sessions
of active treatment or waitlist over 4 weeks. Randomiza- Feasibility outcomes included: accrual, attrition, attendance,
tion was by permuted blocks with allocation pattern blind success/completeness of data collection, and therapist fidel-
to investigators. Immediately following the waitlist period, ity (Table 1). A 10-item, satisfaction survey was completed
participants were offered the treatment. The intervention at endpoint by the caregiver of participants assigned to the
(described below) was designed as an initial phase in prepa- active treatment condition. Each item was rated on a six-
ration of a longer structured intervention in a future larger- point scale (1 = strongly disagree, 2 = disagree, 3 = slightly
scale randomized study. disagree, 4 = slightly agree, 5 = agree, 6 = strongly agree).

Table 1  Feasibility benchmarks

Domain Benchmark Actual

Accrual Less than 15% refusal by eligible participants 0% refusal by eligible participants
Attrition Greater than 88% of participants attending both pre- and 100% of participants attended pre- and post-assessment
post-randomization assessments measures
Attendance to study inter- Greater than 70% of scheduled intervention appoint- Mean = 96.25% attendance to scheduled appointments
vention sessions ments
Pre and post data collection Successful collection of at least 80% of pre-and post- 95.29% of pre- and post-assessment measures gathered
treatment assessment measures
Fidelity Greater than 80% of treatment components implemented Average of 97.51% of components implemented with
with fidelity during a random 15% of sessions integrity

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Journal of Autism and Developmental Disorders
As a measure of satisfaction, we set a benchmark of 80% for
the rating of agree or strongly agree for the item on whether
parents would recommend this intervention to other parents.
Preliminary Efficacy Measures
Two measures were collected pre- and post-treatment to
assess the preliminary efficacy.
MacArthur‑Bates Communicative Development
Inventories‑Words and Gestures
The MacArthur-Bates Communicative Development Inven-
tories-Words and Gestures (CDI; Fenson et al. 2007) is a
reliable and valid, parent-report measure designed to assess
the communication repertoire of children between 16 and
30 months of age across numerous domains. This measure
was selected due to the profound language delay in this sam-
ple. Scores include the child’s number of words understood,
number of words produced, early gestures (e.g., pointing,
waving, etc.), later gestures (e.g., actions with objects), and
total gestures.
Early Social Communication Scales‑Abridged
The Early Social Communication Scales-Abridged (ESCS;
Mundy et al. 1996) is a structured observational measure
of joint attention and requesting repertoires in young chil-
dren with ASD. The assessor sat across the table from the
child and presented mechanical toys, social games, and other
social presses designed to evoke social interaction between
the therapist and the child (Kasari et al. 2014). Assess-
ments were recorded using a camcorder and tripod facing
the child with both the assessor and child visible. A trained
rater, blind to treatment assignment and study time point,
scored behaviors across three domains: Initiating joint atten-
tion (IJA), responding to joint attention (RJA), and initiating
behavioral requests (IBR).
Data Analysis
Feasibility benchmarks were manually tabulated. Accrual
was calculated by dividing the number of participants ran-
domized by the total number of eligible participants multi-
plied by 100. We calculated attrition by taking the number of
participants who completed both pre- and post-randomiza-
tion assessments, divided by the total number of randomized
participants in the trial multiplied by 100. Attendance was
calculated by dividing the actual number of sessions by the
expected number per protocol multiplied by 100. We cal-
culated success of pre and post data collection by dividing
the actual number of assessments by the expected number
multiplied by 100. Finally, fidelity was rated on an 8-item
checklist: 0 = item not covered; 1 = completely covered
(available from the first author) in a randomly selected 15%
sample of intervention sessions. Treatment fidelity was cal-
culated by dividing the number of items completely covered,
by the total number of items in the 15% sample multiplied
by 100. Achievement of these benchmarks was considered a
prerequisite to justify further study of this structured behav-
ioral intervention.
For preliminary efficacy measures, we examined means
with standard deviations and medians with interquartile
ranges within active treatment and wait-list groups at pre-
and post-assessments. Given the small sample size, we used
non-parametric exact Wilcoxon signed-rank tests for p-value
calculation, to compare pre- and post-assessments within
each study group. We calculated effect sizes (ES) within-
groups by dividing Wilcoxon S-statistics by the square root
of N (S/√10). These values were interpreted using Cohen’s
criteria, ≥ 0.2 small, ≥ 0.5 medium, and ≥ 0.7 large. Between
group differences were explored using Analysis of Covari-
ance (ANCOVA) (Supplement). Specifially, post-assessment
least-squares (LS) mean estimates and standard errors were
calculated for each study condition, following adjustment for
baseline (i.e., pre-assessment). Differences in post-assess-
ment LS-means were calculated between study conditions,
along with p-values and effect sizes. Effect sizes for all
ANCOVA results were calculated by dividing the LS-mean
differences by the pooled standard deviations at pre-assess-
ment. Data analyses for efficacy outcomes were performed
using SAS v9.4 (Cary, NC), and statistical significance was
evaluated at 0.05.
Results
Feasibility
Figure 1 shows the progression from recruitment through
trial completion. Participants included ten females with ASD
(mean age of 34.8 ± 8.8 months). Demographic and clinical
characteristics are presented in Table 2. The Vineland-II was
missing for one subject, and demographic information was
missing for one other subject.
All participants who met the inclusion criteria agreed to
random assignment and attended pre- and post-assessment
appointments. On average, participants in the intervention
group attended 96.3% of sessions (range 87.5–100%). We
successfully gathered 95.3% of pre- and post-assessment
measures across all participants. The only measure that
fell below the 80% benchmark was the ESCS. Missing data
on the ESCS were due to disruptive behavior (e.g., flop-
ping to the floor, crying, etc.) during pre- or post-treatment
assessments. Disruptive behavior during the ESCS at pre-
assessment resulted in early termination and missing data
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 Journal of Autism and Developmental Disorders

Referral
-Girls with ASD between the ages of 2
years and 5 years, 11 months.
-Fewer than 5 words

42 Children telephone screened for 31 Excluded

eligibility 9 Did not meet inclusion criteria
6 Too much language
3 Did not have ASD
8 Parent declined
2 Not interested
3 Time commitment
2 Family issues
1 Language barriers
Screening 2 12 Unable to be contacted
-11 Characterization: ADOS-G, 2 Reason not recorded
Vineland-II, Mullen

1 Excluded
1 Too much language

10 Randomized

5 Randomized to receive treatment 5 Randomized to waitlist control

5 Completed post-assessments 5 Completed post-assessments

5 Completed treatment following

waitlist

Fig. 1  Participant flow through referral, screening, randomization, and treatment condition

in two subjects. Treatment fidelity was assessed in 15.3% Preliminary Efficacy

of randomly selected live sessions. On average, therapists
achieved 97.5% fidelity (range 75.0–100%) on essential
treatment components.
Satisfaction
All five parents of girls randomly assigned to active inter-
vention rated agree or strongly agree (M = 5.6; range 5 to
6) on whether they would recommend this intervention to
other parents. All caregivers strongly-agreed that they were
satisfied with the services that their child received (M = 6.0)
(Table 3). All caregivers of children randomized to waitlist
enrolled in the treatment following waitlist.
As noted above, the primary efficacy analyes were pre-
and post comparisons within each study group (see
Table 4). The randomized design permitted blinded
assessment of the ESCS in each study group. Moderate
effect sizes were observed within the active treatment
group on the later gestures and total gestures subscales
on the CDI (both ES = 0.63). A large effect size was
observed on initiating behavioral requests on the ESCS
(ES = 1.42). The waitlist group showed improvement on
two CDI subscales with a moderate effect size on the
words produced subscale and a large effect on early
gestures subscale (ES = 0.63 and 0.95, respectively). In
this small sample, there were no statistically significant

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Journal of Autism and Developmental Disorders

Table 2  Baseline demographics and measure summaries Discussion

Characteristics, N (%) N Summary
N = 10 To our knowledge, this is the first study to evaluate a struc-
tured behavioral intervention in a sample of minimally
Demographics
verbal girls with ASD. Our findings support the feasibil-
Age at evaluation (months), Mean ± SD 9 34.84 ± 8.75
ity of conducting a randomized trial in this population. The
Gender—Female 10 10 (100%)
intervention was delivered with fidelity that exceeded 97%.
Race
These findings are consistent with successful recruitment
White 9 5 (55.6%)
and retention of minimally verbal children with ASD in
Black 2 (22.2%)
other structured behavioral interventions (e.g., Kasari et al.
Multi-race 2 (22.2%)
2014). These feasibility outcomes provide support for the
Hispanic or Latino 9 3 (33.3%)
deliberate inclusion of girls in a larger treatment trial.
ADOS, Mean ± SD
Tager-Flusberg et al. (2005) and others have suggested
Social affect (SA) 10 16.8 ± 2.15
that children with ASD who do not develop vocal language
Restricted repetitive behavior (RRB) 10 5.7 ± 1.95
by the age of 5 years old are unlikely to do so, although
Total ­Scorea 10 22.5 ± 3.27
exceptions have been reported (e.g., Pickett et al. 2009).
Mullen T Scores, Mean ± SDb
Given the long-term implications of severe language delay,
Nonverbal developmental quotient 10 53.49 ± 20.7
additional research in this vulnerable subgroup of children
Visual reception 10 26.1 ± 8.6
with ASD is warranted. Further studies in this population
Fine motor 10 22.6 ± 6.02
will benefit from achievement of consensus on the definition
Receptive language 10 19.5 ± 0.53
of “minimally verbal.” For example, we recruited girls with
Expressive language 10 19.4 ± 0.97
fewer than five words. Compared to studies of children with
Vineland standard scores, Mean ± SDc
20 to 30 words on entry and also described as “minimally
Socialization 9 66.89 ± 8.8
verbal,” our entry criterion appears more stringent. Interven-
Communication 9 57.67 ± 12.33
tions that are effective in children with 20 to 30 words may
Daily living skills 9 58.67 ± 7.28
require a modified approach and longer duration for children
Motor skills 9 71.33 ± 7.75
with more profound impairment (Hus Bal et al. 2016).
a
Total Score Cutoff for Autism Spectrum Disorder = 16 In this 4-week randomized study of ten young girls with
b
M = 50, SD = 10 ASD, we did not detect any within- or between-group statis-
c
M = 100, SD = 15 tical differences (pre to post) on measures of early vocal lan-
guage and early social communication. This is not surprising
given the brief duration and the small sample size (e.g., Lin-
pre- to post- differences within- or between-groups on any stead et al. 2017). For the active treatment group, however,
efficacy measures (see Supplemental material for between moderate effect sizes were observed in later and total gesture
group analyses). subscales on the CDI, and a large effect size was observed
for the initiating behavioral requests subscale of the ESCS.

Table 3  Mean and range of Item M Range

caregiver ratings on Caregiver
Satisfaction Survey (N = 5) This was an acceptable intervention for my child 5.80 5–6
This treatment will make permanent improvements in my child’s life 4.80 4–6
I would suggest the use of this intervention to other parents 5.60 5–6
Most parents would find this intervention suitable for their child 5.40 5–6
This intervention did not result in negative side effects for my child 6.00 6
This intervention was reasonable for the goals that were established 5.60 4–6
I liked the procedures used in this intervention 5.60 5–6
I am confident that the treatment was effective 5.20 4–6
Generally, I am satisfied with the services my child received 6.00 6
Overall, this intervention was beneficial to my child 5.80 5–6

Likert scale: 1 = strongly disagree, 2 = disagree, 3 = slightly disagree, 4 = slightly agree, 5 = agree,
6 = strongly agree

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 Journal of Autism and Developmental Disorders

Table 4  Pre-assessment and post-assessment within study conditions

Measure Treatment Waitlist controls

Mean ± SD; a
Median (IQR) Pre Post Wilcoxon-SR Pre Post Wilcoxon-SRa
N=5 N=5 P-value ­(ESc) N=5 N=5 P-value (ES)

Macarthur
Words produced 1.8 ± 3.03 1.2 ± 1.3 1.000 (0.16) 2 ± 2.92 5.2 ± 7.43 0.625 (0.63)
0 (0, 2) 1 (0, 2) 1 (0, 2) 0 (0, 10)
Words understood 17.6 ± 10.31 29.4 ± 35.87 0.875 (0.32) 40.6 ± 21.17 42 ± 37.86 1.000 (0.16)
23 (7, 24) 17 (8, 25) 42 (35, 45) 28 (19, 42)
Late gestures 8 ± 7.87 8.8 ± 7.85 0.500 (0.63) 11.4 ± 3.36 11.6 ± 3.13 0.750 (0.32)
4 (2, 12) 5 (3, 14) 12 (9, 14) 13 (10, 13)
Early gestures 6.8 ± 1.64 7 ± 1.58 1.000 (0.16) 8.2 ± 3.11 9 ± 2.55 0.500 (0.95)
7 (7, 8) 7 (6, 8) 9 (6, 11) 9 (9, 10)
Total gestures 14.8 ± 8.58 15.8 ± 9.07 0.500 (0.63) 19.6 ± 6.07 20.6 ± 4.39 0.750 (0.47)
10 (9, 19) 10 (10, 23) 23 (13, 24) 19 (18, 23)
ESCSb
IJA total 29 ± 21.74 19 ± 9.19 0.125 (2.06) 14.5 ± 9.68 12 ± 8.6 0.250 (1.06)
24 (17, 35) 22 (12, 25) 13 (6.5, 22.5) 11.5 (5, 19)
RJA total 3.4 ± 1.52 3±2 0.625 (0.79) 4.5 ± 2.65 4 ± 0.82 0.750 (0.35)
3 (3, 3) 2 (2, 4) 4 (2.5, 6.5) 4 (3.5, 4.5)
IBR total 9.6 ± 6.31 15.8 ± 13.97 0.313 (1.42) 4.5 ± 3.11 5 ± 2.94 0.750 (0.53)
11 (3, 15) 12 (10, 13) 4.5 (2, 7) 4.5 (3, 7)
a
P-values calculated via exact Wilcoxon signed-rank (SR) tests; Wilcoxon-SR ES calculated by dividing Wilcoxon-SR S-statistic by square root
of N (S/√10)
b
ESCS Waitlist Controls had observations for four participants; therefore, Wilcoxon-SR ES calculated with a denominator of 8
c
ES > 0.2 small, ≥ 0.5 medium, ≥ 0.7 large

Moreover, large and moderate effect sizes were observed in
the control group on the early gestures and words produced
subscales of the CDI, respectively.
This 4-week intensive treatment was designed to exam-
ine phase one of a longer, structured intervention for young
children with ASD and less than five words. We deliberately
sampled girls for this pilot study to support the relevance of
the intervention in girls prior to designing a larger study.
Our preliminary results showed a large effect size in the
active treatment group for initiating behavioral requests,
which may be promising as a direct measure of treatement
response. Nevertheless, additional efficacy studies in chil-
dren with severe language delay should include a larger sam-
ple size and a longer duration of treatment.
Several limitations warrant mention. First, as noted,
the 4-week intervention is unlikely to be sufficient to pro-
mote meaningful gains for this population. Second, we
did not provide training to caregivers. The incorporation
of caregiver training is warranted in a future study. Third,
we did not track concomitant services for participants.
Fourth, although the ESCS was scored by an experimenter
who was blind to treatment or timepoint, the parent-rated
CDI and social validity ratings were not. Fifth, random
assignment to wait-list controls for time—but not atten-
tion. Future studies could include an an active control
condition. Finally, although deliberate, the inclusion of a
female-only sample limits our ability to discuss differences
in symptom presentation or treatment response based on
sex. Sex differences in ASD have received considerable
attention of late and greater attention to treatment response
by sex are warranted. The current study may support the
feasibility of future trials on treatment response in female
samples with ASD and the inclusion of this sample in
comparative studies based on sex.
Acknowledgments The current study was funded by an Autism Sci-
ence Foundation Postdoctoral Training Award received by the first
author (Grant Number: 16 − 002). We would like to thank Addison
Welch, Jack Tilman, Kira Clement, and Siena Tetali for their assistance
with various aspects of this study.
Author Contributions TC conceived of the study, participated in its
design and coordination, and drafted the manuscript; MAS conceived
of the study and participated in its design and coordination; AA par-
ticipated in the acquisition of data and coordination of the study; TT
participated in the acquisition of data and coordination of the study; BB
participated in the acquisition of data and coordination of the study; SG
participated in the design, interpretation of the data, and performed the
statistical analysis; LS conceived the study, participated in the design
and interpretation of the data, and helped to draft the manuscript. All
authors read and approved the final manuscript.
Funding This study was funded by the Autism Science Foundation
(Grant Number 16 − 002).

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Journal of Autism and Developmental Disorders
Compliance with Ethical Standards
Conflict of interest Tom Cariveau has received a research grant from
the Autism Science Foundation. M. Alice Shillingsburg declares that
she has no conflict of interest. Arwa Alamoudi declares that she has no
conflict of interest. Taylor Thompson declares that she has no conflict
of interest. Brittany Bartlett declares that she has no conflict of inter-
est. Scott Gillespie declares that he has no conflict of interest. Law-
rence Scahill has served as a consultant for Roche, Shire, Supernus,
Neurocrine, Janssen, Yamo, and the Tourette Association of America.
He also receives royalties from Guilford Press and Oxford University
Press.
Ethical Approval All procedures performed in studies involving human
participants were in accordance with the ethical standards of the insti-
tutional and/or national research committee and with the 1964 Helsinki
declaration and its later amendments or comparable ethical standards.
Informed Consent Informed consent was obtained from all participants
included in the study.
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