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J. Indian Assoc. Child Adolesc. Ment. Health 2016; 12(3):230-252
Award paper Niloufer Award 2015
The effectiveness of an intensive, parent mediated, multi-component, early
intervention for children with autism
Raman Krishnan, Merlin Thanka Jemi Alwin Nesh, Paul Swamidhas Sudhakar Russell,
Sushila Russell, Priya Mammen
Address for correspondence: Dr Raman Krishnan, Associate Professor, Saveetha Medical
College, Chennai. Email : [email protected]
Abstract
Aim: Most children with autism do not receive early intervention, unless parents are
trained, in countries with low child mental health resources. To maximize the existing
resource, we evaluated the feasibility and effectiveness of an intensive, parent mediated,
multi-component, early intervention for autism in India.
Methods: Data of 77 children with an ICD-10 diagnosis of autism who completed a 12-
week, five days a week, intervention program and regular practice at home was collected
from the database of a teaching hospital. Intervention components included the standard
intervention protocol, the Psycho-Educational Profile intervention (PEP-R) and the
Carolina Curriculum for Infants and Toddlers with Special Needs. Pre and post-
intervention PEP-R rating of parents were used to evaluate the intervention outcome.
Appropriate bivariate, multivariate and resampling techniques were used to evaluate the
intervention effectiveness.
Results: The effect size (ES) for the intervention was moderate to large for the PEP-R
developmental age as well as perception, fine motor, gross motor, eye-hand coordination,
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cognitive performance and cognitive verbal domain among children with mild to
moderate (ES ranged from 0.70 to 0.88) and severe autism (ES ranged from 0.73 to 0.87).
There was no difference in the intervention effect between the groups (ES ranged from
0.004 to 0.30). The effectiveness of the intervention continued after controlling the
confounding effect of baseline developmental quotient, developmental age and adaptive
skills.
Conclusion: It is feasible to provide an effective parent mediated early intervention for
mild to severe autism in countries where parents are the cornerstone in childhood
disability care.
Key Words: Autism, effectiveness, early intervention, parent-mediated, India.
Introduction
Prevalence of autism is greater than previously recognised at 116.1 per 10 000 [1]. As
impairment emerge during the first three years of life [2], early diagnosis followed by
early intervention can improve outcomes for individuals with autism, possibly more than
in any other developmental disability [3,4].
While there is no cure for autism, an array of interventions like Applied Behavioural
Analysis, Communication-focussed Intervention, Developmental Interventions,
Integrative Programs, Sensory-motor Interventions have been proposed to improve the
symptoms associated with autism. Although reviews of many of the above interventions
show either no or modest intervention effects [5], found them complex and resource
intensive [6], those treatments that demonstrated intervention gain have not only
232
ameliorated autistic symptoms but improved adaptive functioning and parent-child
dyadic relationship [7-10].
Interestingly, among the many intervention models available, parent mediated early
interventions are known to have the most significant intervention effects which have not
been tested in low and middle income countries with paucity of child mental health-care
resources [11]. Therefore, the current study was designed to evaluate: (1) if it is feasible
to provide a therapist guided, parent mediated, multi-component, early intervention for
children with autism in a country with low child mental health resources; (2) if this
multi-component intervention program, which is an integration of a standard autism
treatment protocol combined with the Psycho-Educational Profile intervention (PEP-R)
and The Carolina Curriculum for Infants and Toddlers with Special Needs (CCITSN), is
effective for children with autism; (3) if the intervention is more effective for either the
mild to moderate or severe autism group.
Methods
Setting and sample
This study was conducted at the Autism Clinic, Child and Adolescent Psychiatry Unit of a
tertiary care, teaching hospital in South India. The charts of children and adolescents
enrolled for autism training either for a residential or day care program with complete
data set were identified from the unit’s database for a three-year period. The enrolled
toddlers and children had an ICD-10 based clinical diagnosis of Autism Spectrum
Disorder (Pervasive Developmental Disorder). Children with a diagnosis of Overactive
disorder associated with mental retardation and stereotyped movements (F84.4) were
233
excluded because of its uncertain nosological status [12]. All clinical diagnoses were
made by consultant psychiatrists and endorsed by the multidisciplinary team with a mean
(SD) clinical experience of 12.74(8.21) years.
Measures
The Psycho-Educational Profile-Revised (PEP-R) [13] was developed to assess children
with autism and formulate their Individualized Education Programs (IEP). The
Developmental Scale of PEP-R assesses the overall functioning of the child, the
developmental age, based on the imitation, perception, fine motor, gross motor, eye-hand
coordination, cognitive performance and cognitive verbal subscales. The PEP-R also
includes a Behavioral Scale, which is used to identify the degree of behavioral
abnormality The Developmental Scale of PEP-R has been validated for children with
autism in India [14]. The pre-intervention and post-intervention PEP-R scores rated, in
terms of improvement in months, was used as the intervention outcome measure in this
study.
The Childhood Autism Rating Scale (CARS) [15], is a 15-item behavior-rating scale,
designed to detect and quantify symptoms of autism. Children with scores of 30.5 to 37
are rated as mildly–moderately autistic, and 37.5 to 60 as severely autistic by CARS. This
measure has been validated for India [16].
Gesell’s Developmental Schedule (GDS) [17] gives the developmental skills in four
areas in months: motor behavior, adaptive behavior, language and personal as well as
social behavior.
234
Vineland Social Maturity Scale (VSMS) [18] measures the adaptive skills of the child in
eight areas in weeks: self help general, self help dressing, self help eating, socialization,
self direction, communication, locomotion and occupation.
As the baseline GDS developmental quotient and VSMS adaptive skills can confound the
intervention outcome independent of the severity of autism both had to be controlled in
this study [19, 20].
The study was reviewed and approved by the local institutional review board.
Intervention
Within the first week of starting the intervention and at end of 12th week the parent
assisted by the therapists assessed the child using the PEP-R and CCITSN assessment
schedules. This clinic based multi-component early intervention package had three
components.
(1) the standard clinical intervention being used for the past 11 years in the clinic that
included training in self-care skills, social skills and control of problem behaviour using
special education and behavioural techniques. Throughout the 12-week program, the
parents, using interactive group psycho education technique, were taught about various
aspects of autism and developmental disabilities. This psycho education module is
proven to improve the knowledge and attitude of the parents towards developmental
disability [21].;
(2) The PEP-R intervention [22] included teaching activities from Individualized
Assessment and Treatments for Autistic and Developmentally Disabled Children,
235
Teaching Strategies for Parents and Professionals and Teaching Activities for Autistic
Children and
(3) the CCITSN module [23] addressed the intellectual disability component with focus
mainly on cognition, communication, social adaptation, fine motor, and gross motor of
the children using a developmental approach.
Each session of the therapist guided, parent mediated intervention process would start
with a 10-minute briefing about the goals for the day which are set on a weekly basis.
The child was engaged in play routines and social stories and each parent–child dyad
received applied behaviour analysis aimed at improving the behavioural control and
interactive skills of parents using principles of rewarding and guided practice. The whole
intervention was in the form of closed group sessions conducted five times a week by two
therapists and each session lasted for 4 hours. The parents were encouraged to continue
the intervention, at home using adaptations to suit the home environment. Participation
from other significant family members was encouraged.
Data analysis
Non-parametric analyses were used because of the relatively small and skewed sample.
The baseline differences between the groups were analyzed using Fisher’s Exact Test and
Mann-Whitney U test for the categorical and continuous variables respectively. To
compare the change in PEP-R scores within the mild to moderate and severe autism
group, before and after intervention, Wilcoxon matched pair rank test was used. Based on
the median of the post and pre intervention PEP-R scores, within groups and between
groups, the effect size (ES) for both groups was calculated using the formula r=z/n. For
236
the comparison of difference (post-pre intervention) between the groups, Mann-Whitney
U test was used. Also, 95% confidence intervals were calculated by resampling with
replacement, using boot strapping (1000 times), for all the effect sizes. In addition, for the
outcomes, multiple regression analysis was used to take into account the possible
confounding effect of the developmental age, adaptive skills and baseline PEP-R
developmental age imbalance autism groups. P<0.05 (2-tailed test) was considered
significant. Statistical analyses were performed using the SPSS (version 19) and R
(Version 2.14.2).
Results
Participant and baseline characteristics
The mean (SD) chronological age of the children was 3.66(1.64) years. There were more
boys (81.8%) than girls (18.2%) in the sample. The chronological age (mild vs. severe =
3.74 (1.86) vs. 3.64 (1.59), z=-0.20; P=0.8) in the mild to moderate and severe autism
group were comparable at the baseline. Similarly, other socio-demographic and clinical
variables were not different between the groups (Table 1).
As expected, the mean (SD) CARS score [mild vs. severe = 34.03 (1.58) vs. 41.24
(2.88), z= -5.95; P=0.001] was statistically different between the groups. Also the GDS
developmental quotient [mild vs. severe = 62.62 (19.27) vs. 48.08 (14.11); z=-2.76;
P=0.006] and VSMS adaptive functioning [mild vs. severe = 2.71 (1.03) vs. 2.04 (0.73);
z=-2.48; P=0.01] were statistically significantly different between the groups.
The mean (SD) outcome measure, total PEP-R score (developmental age), at the baseline
was statistically significantly different between the groups [mild vs. severe =
25.43(11.13) vs. 17.13(7.18), z=-2.72; P=0.007]. Similarly, the domains of imitation,
237
238
perception, fine-motor, gross motor, eye hand integration, cognitive performance and
cognitive verbal were statistically significantly different between the mild and severe
autism groups.
Feasibility of parent mediating intervention
The attrition of parents from this intensive multi-component early intervention was only
2% over three months of training and there was no difference between the groups.
Clinical observations demonstrated that parents were able to implement different aspect
of the intervention effectively. The ability to continue the training at home, for about 3 to
4 hours a day (high level) was observed in 74% of the parents. There was no difference
between the groups in participation by other family members in the training.
Effectiveness of the intervention within group
The intervention was effective in children with mild to moderate and severe autism in the
bivariate analysis (Table 2). The mean (SD) gain in the total PEP-R score (developmental
age) was 9.88 (3.47) months and 7.50 (1.97) months among those with mild to moderate
and severe autism respectively. The effect size (ES) for the intervention, as indicated by
the PEP-R developmental age, was 0.87 for both groups indicating a large effect size.
The effect size for the various PEP-R subscale scores also varied between 0.70 to 0.88 for
the mild to moderate autism group and 0.73 to 0.87 for the severe autism group,
indicating moderate to large effect size for the intervention. The confidence intervals for
the effect sizes, indicated that the intervention effects would fall within the mentioned
range 95% of the time and remain significant even if the study were to be repeated as
many as thousand times (Table 2).
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240
Effectiveness of the intervention between groups
In the bivariate analysis, when the post-intervention differences in the total and subscale
PEP-R scores was compared, there was no statistically significant difference except in the
cognitive verbal subscale (Table 3). The mean (SD) gain in the developmental age was
2.37 (1.16) months between autism groups. The effect size for the intervention was 0.21
between the mild and severe autism group. The intervention effect for the PEP-R
subscales of cognitive verbal and cognitive perceptual was 0.20 and 0.30 respectively
suggesting a small intervention effect. The effect size for all the other PEP-R subscales
varied between 0.004 and 0.18 indicating no difference in the intervention effect between
the groups. The confidence intervals for the effect sizes, indicated that the intervention
effects would fall within the mentioned range 95% of the time and remain insignificant
even if the study were to be repeated as many as thousand times (Table 3).
In the multivariate analyses, despite controlling for the possible confounding effect of the
developmental age, adaptive functioning and the baseline PEP-R differences, neither the
post-intervention total PEP-R-score nor any other subscale demonstrated a statistically
significant difference between the groups (Table 4).
241
Discussion
In summary, the findings of this study are that: (1) it is feasible to provide a parent
mediated multi-component, early interventions for children with autism in a low child
mental health resource country; (2) this intervention is effective for enhancing the PEP-R
developmental age and its domains for children with autism (both mild to moderate and
severe group). It is proven that it is critical to include parents in the early intervention for
242
243
autism and without parental participation the intervention gains are unlikely to be
maintained [24]. The observation based on this real world study can pave way to
primary-care intervention models involving parents.
The overall intervention gain in this study was an increase in the developmental age of
about 9 and 7.6 months during the 3 month training among children with mild to
moderate and severe autism respectively. The within group intervention effect size (ES)
of 0.87 in our study was comparable with the effect size of 0.88, 0.82 and 0.80 reported
in the literature [25-27] but lesser than that documented by others [28-30]. Our
intervention effect size was far better than the -0.05 reported by Salt et al [31].
The intervention was equally effective in the mild to moderate and severe autism group
except for the cognitive verbal domain. This difference in the cognitive verbal domain
did not persist when the confounders were controlled. Similar intervention effectiveness
across varying severity of autism has also been documented in the literature although
effect sizes are not available [32].
We speculate that our intervention was greatly effective, firstly, because of the
integration of the multiple components as it also addressed the adaptive behaviour and
behavioural problems. Studies documenting the efficaciousness of various multi-
component interventions have consistently revealed that they improve the developmental
age significantly (ES = 0.92 to 1.35), develops play behaviours (ES = 0.84 to 1.18) [33],
decreases symptoms of autism (ES = 2.27) [34] , improves other abilities like perceptual–
fine motor, cognition, language, social/emotional (ES = 0.66 to 1.04) and
244
receptive/expressive language skills (p =0.001, ES = 1.64) had significantly improved
with multi-component intervention [34], which is much similar to our finding.
Secondly, the parent involvement possibly has been an enhancing factor in the outcome
measure in this study which is reported in literature as well [35-38]. When parents were
used as co-therapists in the training of their children, pre-academic skills (ES=0.59),
problem behaviours (ES= 1.07 to 1.38) (36), face gaze (ES=1.04) and socialisation
(ES=1.27), autism symptom clusters (ES = 0.86) [39] and language skills (ES=0.86) had
significantly improved. It is also known that parents can be trained to effectively
implement early interventions for children as young as 3 years of age [40].
Thirdly, the early intervention could have played a role in the intervention success. The
mean age of the children in our study was 3.66(1.64) years, possibly the earliest age that
can be enrolled for clinical intervention in a country with poor awareness about autism
[41]. The role of early intervention in improving outcome has been documented [42].
Fourthly, the intervention program was intensive in its approach and perhaps enabled
children to learn skills. Our intervention was for 4 hours a day for 5 days a week for 12
weeks. Intensive approaches have been known to bring about significant therapeutic
effects in areas of intelligence, self-help, pre-academic skills, communication (ES=0.57
to 2.14) [43,33] and autistic symptoms (ES = 2.58) in a previous study [45].
Finally, closely related to the intensity is the treatment duration. Although the clinic
based treatment was only for 20 hours a week, the parents seemingly followed training at
home, which couldn’t be quantified. A rough estimate is that the parents would have
achieved about 20 to 40 hours of total training a week. Although the recent studies show
245
that longer treatments, of more than 40 hours, yielded positive outcome (ES = 0.86 to
2.11) [46] considering home setting, researchers suggest at least 30 hours of training [30].
Limitations would include its retrospective design. The generalisability is compromised
as the study children have greater familial resources and less heterogeneity than those
served in community settings [47]. But these children in clinical setting present more
challenges [48] and hence this study which has participants closer to real world improves
the external validity of our finding.
In conclusion, we document that it is feasible to provide an intensive, therapist guided,
parent mediated, multi-component, early intervention program in an Indian setting. In
future, the best age for intervention, optimal intensity, duration of treatment and parental
involvement as predictive factors need to be quantified, and thus prospective pragmatic
trials with factorial design are warranted.
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Raman Krishnan, Associate Professor, Saveetha Medical College, Chennai , Merlin
Thanka Jemi Alwin Nesh – Psychologist, Christian Medical College, Vellore,Paul
Swamidhas Sudhakar Russell- Professor and Head, Sushila Russell,Assistant Professor,
Clinical Psychology, Priya Mammen, Professor, Child and Adolescent Psychiatry,
Christian Medical College, Vellore.