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An Intervention for Sensory Difficulties in Children with Autism: A Randomized Trial. Abstract. This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4–8 years, using a randomized trial design.
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Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 1. Goal Attainment Scales (primary outcome), and also scored significantly better on measures of caregiver assistance in self- care (p = 0. Usual Care control group (n = 1.
The study shows high rigor in its measurement of treatment fidelity and use of a manualized protocol, and provides support for the use of this intervention for children with autism. Findings are discussed in terms of their implications for practice and future research. Keywords: Autism spectrum disorders, Intervention, Sensory functions.
Introduction. Difficulty processing, integrating and responding to sensory stimuli has been described as a feature of autism spectrum disorders (ASD) since the disorder was first identified. Current estimates show that between 4. ASD demonstrate these sensory difficulties (Ben- Sasson et al.
Lane et al. 2. 01. Restricted, Repetitive Patterns of Behavior, Interests, or Activities’ (American Psychiatric Association 2. Families report that behaviors associated with difficulty processing and integrating sensory information create social isolation for them and their child, restrict participation in daily living activities (Schaaf et al.
Hilton et al. 2. 00. Baker et al. 2. 00. Ashburner et al. 2. Reynolds et al. 2. Watson et al. 2. 01. Hochhauser and Engel- Yeger 2. Consequently, interventions to address problems associated with difficulty processing sensory information, such as occupational therapy using sensory integration (OT/SI), (Ayres 1.
ASD (Mandell et al. Green et al. 2. 00.
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Goin- Kochel et al. There is emerging evidence regarding positive outcomes of OT/SI for children with ASD (Pfeiffer et al. Fazlioglu and Baran 2. Schaaf 2. 01. 1 for a review), however, methodological limitations preclude definitive conclusions. Hence, there is the need for a rigorous study of OT/SI that includes a manualized protocol and measurement of treatment adherence (Case- Smith and Arbesman 2. Watling et al. 2. Fortunately, a validated measure of treatment fidelity that describes the key principles of the sensory integrative approach and provides guidelines for best practice is now available (Parham et al.
May- Benson et al., in press). Importantly, this measure provides a means to evaluate the fidelity of OT/SI in a clinical trial while assuring internal and external validity; a standard that is followed in the current study. A second advancement that enhances the testing of this intervention is data showing that Goal Attainment Scaling (GAS) is a useful outcome measure for studies of interventions for ASD (Ruble et al. GAS is used to measure functional and meaningful aspects of an individual’s progress (Mailloux et al. Kiresuk et al. 1. In autism, inherent heterogeneity often confounds findings, and thus, it is important to utilize outcome measures that are sensitive to individual outcomes. GAS has been shown to be a substantive and sensitive approach to evaluate progress on individualized goals in randomized controlled trials of psychosocial interventions for children with autism provided that specific quality indicators are present.
These include that goals are independently rated, evaluated for equivalence between groups (comparability), scaled with equidistance, have measurable criteria, and clear, identifiable benchmarks (Ruble et al. A further strength of using GAS is that it provides a means to identify and measure outcomes that are parent- chosen and thus, meaningful to family.
Given the increased emphasis on measurement of outcomes that are meaningful to the client or family (PCORI, http: //www. GAS provides a model for best practice. Given the need for a rigorous randomized trial of OT/SI for individuals with ASD, the primary purpose of this study is to evaluate the efficacy of OT/SI following a manualized protocol on individual goal attainment (primary outcome) in comparison to usual care (UC). The secondary purpose was to evaluate the impact of this approach on the child’s sensory behaviors, adaptive behaviors and functional skills. Methods. Participants. Thirty- two children participated in this study. A convenience sample of eligible families was recruited from the children’s hospital where the study took place and the surrounding community.
Families were eligible to participate if their child: (1) was between the ages of 4. Autism Diagnostic Interview- Revised (ADI- R) (Lord et al. Autism Diagnostic Observation Schedule (ADOS) (Lord et al. IQ cut score is based on findings from an earlier study where we assessed the feasibility of conducting this intervention with children with ASD—Schaaf Benevides et al. Sensory Profile (SP—Dunn 1. Sensory Integration and Praxis Test (SIPT- Ayres 1. Child characteristics are also shown in Table 1 below for the treatment (n = 1.
UC control group (n = 1. In keeping with current gender prevalence estimates of ASD (CDC, 2. Treatment: 1. 4 males, 3 females; UC: 1.
Caucasian (treatment: 1. White, 1 not- reported; UC: 1. White, 2 Asian). Highest parent- reported level of education in both groups was similar, with 1. UC group reporting a 4- year degree or higher. Age, autism severity, cognitive level, and non- study related services were similar between the two groups. Non- project services, or “usual care” (UC) received during the study period was similar between the groups and documented by parents logging their child’s weekly services in hours per week.
Usual care included non- study related services such as speech and language services, behavioral interventions, educational program and other therapies as described in Table 1. Child characteristics and non- study services received.
Overview and Timeline. Data for this randomized clinical trial were collected at a single project site in central New Jersey, between 2. The study was approved by the first author’s research ethics committee.
Figure 1 provides an overview of the recruitment, enrollment, randomization and retention flow. Following phone screening for eligibility with interested parents, child participants were scheduled for confirmation of autism diagnosis using the ADOS and the ADI- R and, for children who did not have a current cognitive assessment (within the past 1. If the child met inclusion criteria, parental consent, child assent, and permission to videotape treatment sessions was obtained following the approved procedures.
Next, independent evaluators, trained in the administration of the assessments, conducted the pre- intervention assessments. These blinded evaluators (n = 2) were highly experienced therapists who had been licensed to practice occupational therapy for a mean of 2. ASD (mean = 1. 9 years, range = 1. These evaluators also were trained and certified in the use of the SIPT for an average of 1. Participant recruitment, enrollment, randomization and retention. Following the completion of the initial assessments, the independent evaluators analyzed the assessment data (assessments are listed below) and met with the parents to identify five goals that would be addressed during the study period. These goals were scaled according to GAS Methodology (Kiresuk et al.
To maintain a level of objectivity, parents did not view the goal attainment scales upon their completion or during the study period. Independent evaluators remained blind to child allocation during the study period and post- testing phases, and completed the post- intervention assessments using the same assessment battery. Randomization, Allocation Concealment and Implementation. Once goals were identified and scaled, children were randomly assigned using random number generations provided by the study statistician to either the treatment or UC control group using random permuted blocks within four strata. IQ) and autism severity score (high IQ/high severity, low IQ/low severity, high IQ/low severity, low IQ/high severity). A high IQ was classified as a score of 8.
IQ was classified as below 8. Autism severity was determined with the ADOS using procedures to calculate severity scores described by Gotham et al. A severity score of 6–1. In total, eight children were randomized in the low IQ/high severity strata, one child randomized in the low IQ/low severity strata, 2. IQ/high severity strata, and one randomized in the high IQ/low severity strata.
The randomization sequence and opaque envelopes with randomization allocation group (treatment or UC) were generated by the Division of Biostatistics and remained concealed until the child’s strata was determined using the criteria outlined above. Children were randomized by the second author or principal investigator in order of completion of pre- test assessment and goal scaling. The number of days between enrollment and randomization was not significantly different between the treatment group (M = 3.
SD = 1. 4) and UC Control group (M = 3. SD = 8), t(3. 0) = 1. Participant children randomly allocated to the treatment group received the intervention three times per week in 1- hour sessions for 1. All parents were instructed to continue with their child’s usual weekly treatments and to document their child’s non- study related treatments on a treatment log and to report weekly if any unusual events occurred in their child’s lives (e. Following the study period, both groups underwent post assessment by the independent evaluators at a different location to further ensure blinding.
Information on subjects’ completion of allocated intervention and attrition is displayed in Fig. 1. Participant recruitment, enrollment, randomization and retention. Intervention. Children in the treatment group received a manualized OT/SI intervention (Schaaf et al.