[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: Participants were selected by searching the files to eliminate those who had previously been part of any sensory integration program or who had epileptic seizures. The selected group was between 7 and 11 years of age. The majority of the children could not use language to communicate and were part of the special education program at the center.
Intervention Characteristics
Intervention
Kontrol
Sanseregulering, Sensory evaluation form for children with autism
Authors name: YESIM FAZLIOGLU
Institution: Trakya University, Edirne
Email: yfazli@hotmail.com
Address: Trakya Universitesi Egitim Fakdtesi, Okuloncesi Egitim A.B.D., Edirne, Turkey
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Intervention Characteristics
Intervention
Kontrol
Funktionsniveau (klinikerbedømt), CGAS
Sanseregulering, PRILS-10 total
Livskvalitet (forældrebedømt), PedsQL total score
Authors name: Hansashree Padmanabha
Institution: Department of Neurology, National Institute of Mental Health andNeurosciences, Bengaluru, India
Email: doctorpratibhasinghi@gmail.com
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Included criteria: Participants in the study were a convenience sample of children diagnosed with autism orPDD not otherwise specified (NOS) on the basis of the Diagnostic and Statistical Manual ofMental Disorders (4th ed., text rev.; American Psychiatric Association, 2000) criteria. Allparticipants were between ages 6 and 12 (mean [M ] age 5 8.8) and attended a summertherapeutic activities program. A total of 32 boys and 5 girls participated in the study, a ratiothat is consistent with the prevalence data of ASDs (Fombonne, 2003). Additionalinformation on the participants, including coexisting treatment and class placement, isprovided in the Results section. For this study, only children diagnosed with autism orPDD– NOS were included. Diagnoses were confirmed by parents and caregivers on thebasis of reports from qualified diagnosticians. A total of 21 children diagnosed with autismand 16 children diagnosed with PDD–NOS participated. Children diagnosed with Aspergersyndrome or another PDD were excluded from the study to promote greater homogeneity inthe sample. In addition, participants were included only if they were identified with asensory processing disorder as determined through a T score of ≥60 on the SensoryProcessing Measure (SPM; Parham & Ecker, 2007), which was completed by theparticipants’ parents, and a comprehensive evaluation by a clinician who was expert in SI.
Intervention Characteristics
Intervention
Kontrol
None of our prespecified outcomes were reported in this study
Authors name: Beth A. Pfeiffer, PhD, OTR/L, BCP,
Institution: Department of Occupational Therapy, Temple University, Department ofRehabilitation Sciences
Email: bpfeiff@temple.edu
Address: Department of Occupational Therapy, Temple University, Department ofRehabilitation Sciences, 3307 North Broad Street, Philadelphia, PA 19140.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Overall
Included criteria: Families were eligible to partici-pate if their child: (1) was between the ages of 4.0 and 7.11at the time of enrollment, (2) had a diagnosis of an autismspectrum disorder from a licensed psychologist based onthe results of the Autism Diagnostic Interview-Revised(ADI-R) (Lord et al.1994) and the Autism DiagnosticObservation Schedule (ADOS) (Lord et al. 1999), (3) had anon-verbal cognitive level of[65 (this IQ cut score isbased on findings from an earlier study where we assessedthe feasibility of conducting this intervention with childrenwith ASD—Schaaf Benevides et al.2012); (4) demon-strated difficulty processing and integrating sensory infor-mation as measured by the Sensory Profile (SP—Dunn1999; 3 or more subscales or total test score in the definitedifference range) or the Sensory Integration and PraxisTest (SIPT- Ayres1989; score of\-1.0 on 3 or moresubtests); and (5) parents were willing to attend 3 weeklysessions for the duration of the 10-week study period and torefrain from initiation of any new treatments includingmedications during the study period.
Excluded criteria:
Pretreatment:
Intervention Characteristics
Intervention 1
Kontrol 1
Funktionsniveau (forældrebedømt), Vineland composite
Sanseregulering, PDDBI subscale SP approach
Sanseregulering, Sensory evaluation form for children with autism
Sponsorship source:
Country:
Setting:
Comments:
Authors name: Roseann C. Schaaf
Institution: Department of Occupational Therapy, Faculty of the FarberInstitute of Neuroscience, Thomas Jefferson University
Email: Roseann.schaaf@jefferson.edu
Address: 901 Walnut Street, Suite 605, Philadelphia, PA 19107, USA
Wrong study design
Wrong study design
Wrong study design
Wrong intervention
Conference poster
Wrong study design
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "They were ran- domly assigned to a treated group and control group based on a stratifica- tion procedure to ensure equivalence of groups. Children were assigned to experimental and control groups randomly, matching on age and sex as pos- sible. Fifteen children (12 boys, 3 girls) were in the experimental group, and 15 children (12 boys, 3 girls) with similar characteristics were in the control group. These two groups were matched for age, sex, and level of function."
Judgement Comment: Insufficient information on sequence generation
Quote: Computer-generated table of random numbers per- formed simple randomization.
Quote: "Procedures <b>The participants were randomly assigned to two treatment groups: (1) SI or (2) FM. A statistician who was not associated with the implementation of the study completed the random assignment using version 16 of the Statistical Package for the Social Sciences (SPSS) software program (SPSS, Inc., Chicago).</b> The group assignments were provided"
Quote: "Once goals were identified and scaled, children were ran- domly 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 1 based on cognitive level (hereafter referred to as IQ) and autism severity score (high IQ/high severity, low IQ/low severity, high IQ/low severity, low IQ/high severity)."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Insufficient information on allocation concealment
Quote: The allocation sequences were concealed using sequentially numbered, opaque, and sealed envelopes. A person not involved in patient care in the study performed randomization and allocation concealment.
Quote: "(1) SI or (2) FM. <b>A statistician who was not associated with the implementation of the study completed the random assignment using version 16 of the Statistical Package for the Social Sciences (SPSS) software program (SPSS, Inc., Chicago). The group assignments were provided to a project coordinator who was the on-site coordinator for the interventions. The researchers and parents or caregivers who completed the pre- and posttesting were blinded to group assignment. The</b> researchers completed comprehensive occupational therapy"
Judgement Comment: Insufficient information on allocation concealment
Quote: "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 = 30.5, SD = 14) and UC Control group (M = 35.4, SD = 8), t(30) = 1.18, p = 0.25."
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "balls, and a touch board. <b>In the beginning, the families were informed about the aim and dura- tion of the study, and importance of continuity in the program was empha- sized. A physiotherapist who helped develop the motor items evaluated mus- cular tonus, motor development, and posture. A study plan showing the days and hours of application was prepared for every child, and the children were taken to the sensory integration ses- sions individually.</b> Before a session, a special"
Judgement Comment: Blinding not feasible, and may influence outcome
Quote: This was a 12 wk open-label parallel-group pilot-randomized controlled trial.
Judgement Comment: Blinding not feasible and is likely to influence self-reported outcomes
Quote: "on-site coordinator for the interventions. <b>The researchers and parents or caregivers who completed the pre- and posttesting were blinded to group assignment.</b> The researchers completed comprehensive occupational"
Judgement Comment: Blinding of participants not feasible. However, likely blinding of personnel, caregiver and parents (page 4)
Quote: "our findings must be interpreted with caution given that the parents were not blind to the intervention."
Quote: "Following the study period, both groups underwent post assessment by the independent evaluators at a different location to further ensure blinding."
Quote: "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 Meth- odology (Kiresuk et al. 1994). To maintain a level of objectivity, parents did not view the goal attainment scales upon their completion or during the study period."
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Blinding not feasible, and may influence reporting of outcome
Judgement Comment: Blinding not feasible and is likely to influence self-reported outcomes
Quote: "on-site coordinator for the interventions. <b>The researchers and parents or caregivers who completed the pre- and posttesting were blinded to group assignment. The</b> researchers completed comprehensive occupational therapy"
Judgement Comment: Likely blinded outcome assessors.
Quote: "obtained following the approved procedures. <b>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</b> for a mean of 28"
Quote: "Following the study period, both groups underwent post assessment by the independent evaluators at a different location to further ensure blinding."
Quote: "Independent evaluators remained blind to child allocation during the study period and post-testing phases, and com- pleted the post-intervention assessments using the same assessment battery."
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Data presented for n=15 in each group (table 2) as randomized. Likely complete outcome data.
Quote: Of the 40 eligible children, 21 were randomized to SI group and 19 to ST group. One patient in the SI group was non- compliant with HBSI from 4th wk until 10th wk due to time constraints of the parent. All 40 patients were included for analysis. No significant adverse events were noted during the study.
Judgement Comment: One protocol deviation in IG group, however appropriate ITT analysis.
Quote: "advanced training in SI assessment. <b>Thirty-seven students completed the intervention phase of the study, 20 of whom received the SI interventions and 17 of whom received the fine motor (FM) interventions. Four children dropped out of the study and were not included in the 37. Two were removed from the program by their parents, and two were asked to leave the program because of aggressive behaviors before the beginning of the interventions.</b> Pfeiffer et al. Page 3"
Judgement Comment: Insufficient description of the dropout group allocation (n=4), thus cannot determine based on the information whether the dropouts in the groups were equally distributed.No appropiate statistical analysis
Quote: "and Received OT/SI intervention (n=17) <b>Lost to follow-up (n=2) Parent unable to attend post-test with child and completed GAS interview by phone (n=1) Parent did not complete post- testing (n=1)</b> Allocated and Received Usual Care"
Judgement Comment: Two drop outs from UC group and per protocol analysis.
Reporting bias due to selective outcome reporting
Judgement Comment: There are no reference to study protocol, but appears to report on all outcomes of interest
Quote: Trial registration Clinical Trials.gov Identifier NCT02491645; Clinical Trials Registry of India (CTRI/2015/12/006418)
Judgement Comment: Protocol available. No deviations noted.
Quote: "Sensory Processing Measure—The SPM"
Quote: "Social Responsiveness Scale—The"
Quote: "Quick Neurological Screening Test, 2nd Edition—The QNST–II"
Quote: "Goal Attainment Scaling—GAS"
Quote: "Vineland Adaptive Behavior Scales, 2nd Edition—The VABS–2"
Judgement Comment: No protocol, but only a selection of the intervention effekt on the reported outcomes were presented, and QNST-11 scores were reported from pre and post test but without variance and only from subgroup (page 8)
Judgement Comment: No reference to study protocol, but appears to report on all outcomes
Bias due to problems not covered elsewhere in the table
Judgement Comment: The study uses non-validated questionnaire to define sensory regulation
Judgement Comment: The study appears to be free from other sources of bias
Quote: "with a larger sample. Acknowledgments <b>We thank the Autism Speaks Foundation for the grant funding provided for the completion of this study. We also thank the organization that provided the setting and contacts for the study, along with all the families and children who participated. In addition, we thank Joe Glutting for his assistance in statistical analyses and Keith Parker for his contributions to the data organization process.</b> References American Psychiatric Association. Diagnostic"
Judgement Comment: The study appears to be free from other sources of bias
Quote: "This Grant was funded by an Autism Speaks Foundation Treatment Grant (#3797). The"
Judgement Comment: The study appears to be free from other sources of bias