Effect of Snoezelen-Based Occupational Therapy Intervention on Sleep and Behavior Problems in Infant at Risk of Autism
Investigation of the Effect of Snoezelen-Based Occupational Therapy Intervention on Sleep and Behavioral Problems in 18-36 Months Children at Risk of Autism
1 other identifier
interventional
21
1 country
1
Brief Summary
Objective: Sleep and behavioral problems are common in infants at risk of autism. This study aims to examine the effect of Snoezelen-Based Occupational Therapy intervention on sleep and behavioral problems in infants at risk of autism. Design: Twenty-four infants (15 boys, 9 girls) at risk for autism were randomized to the intervention group (n = 12; 28.33 ± 6.52 months) and the control group (n = 9; 30.11 ± 5.20 years). The intervention group received Snoezelen-Based Occupational Therapy intervention in addition to the conventional 8-week sensory integration intervention, while the control group received only the conventional sensory integration intervention. Both groups assessed sleep and behavioral problems using the Brief Infant Sleep Questionnaire (BİSQ) and the Vineland Social-Emotional Early Childhood Scale (VSEES) pre and post eight weeks of intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 30, 2023
CompletedFirst Posted
Study publicly available on registry
December 11, 2023
CompletedDecember 14, 2023
December 1, 2023
2 months
November 30, 2023
December 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Investigation of the change in sleep quality with Brief Infant Sleep questionnaire (BİSQ) in the intervention group receiving Snoezelen-Based Occupational Therapy training in 8 weeks
Brief Infant Sleep questionnaire (BİSQ): The scale assesses whether the infant/child has sleep problems and the level of sleep with seven parameters. These seven parameters are: 1. sleep onset time, 2. time to fall asleep, 3. frequency of nighttime awakenings, 4. duration of insomnia at night, 5. duration of nighttime sleep, 6. duration of daytime sleep, 7. total sleep duration and, 8. sleep quality. In parameters 1 to 7, the respondent responds in terms of duration (hours or minutes). In question 8, he/she gives a score between 1 and 6. 1: very poor 6: very good. The higher the score, the better the sleep quality. It was used to measure the change in sleep-related problems of infants in the intervention group at 8 weeks. Information was obtained by filling in the information from the parents of the infants.
Baseline and Week 8
Investigation of the change in childrens social-emotional development with Vineland Social-Emotional Early Childhood Scale (VSEES) in the intervention group receiving Snoezelen-Based Occupational Therapy training in 8 weeks
Vineland Social-Emotional Early Childhood Scale (VSEES): The VSEES is used to assess the social-emotional development of children from birth to 5 years and 11 months. The scale evaluates the interaction/communication dimension, social communication, interest in play, coping and adaptation parameters of infants with its sub-parameters. Score Key: 2=Usually 1=Sometimes 0=Never O= Unlikely B= I don't know. The higher the score, the better the result. It was used to measure the change in social-behavioral problems of infants in the intervention group at week 8. The information was obtained by filling in information from the infants' parents.
Baseline and Week 8
Study Arms (2)
Traditional Sensory Integration Intervention Group
EXPERIMENTALConventional Sensory Integration Intervention Based on Sensory Processing Theory, sensory integration intervention increases a childs ability to process and integrate sensory information and thus create more organized and adaptive behaviors. Sensory-enriched environments use fun interactive games and activities. Sensory integration intervention is carried out by creating an intervention program to create, understand, and eliminate the deficiency of the sensory process. A conventional sensory integration intervention two sessions (per sessions 45 minutes) a week, was planned for 18-35-month-old infants at risk of ASD in both groups participating in the study. Session planning and activity selection were based on TSP-2 results. In particular, the occupational therapist supported the infant\'s active participation in the activities.
Snoezelen-Based Occupational Therapy Group
ACTIVE COMPARATORSnoezelen- Based Occupational Therapy Intervention Different from sensory integration interventions, Snoezelen interventions are environments with all sensory stimuli, such as auditory, visual, tactile, gustatory, olfactory, and vestibular stimuli, in the same environment and where therapeutic guidance and commands are not given to the individual. These interventions aim to reduce agitation, depression, and aggression in individuals and increase daily living activities, functional performance, and well-being. Psychiatric clinics, schools, rehabilitation centers, and occupational therapy clinics are some places where it is used. Some materials found in Snoezelen rooms are bubble tubes, fiber optic light cables, projectors, vibrating massagers, light tactile stimulation materials, aromatic scent emitting devices, music sets, and relaxing music and swings.
Interventions
Snoezelen- Based Occupational Therapy Intervention Different from sensory integration interventions, Snoezelen-based interventions are environments with all sensory stimuli, such as auditory, visual, tactile, gustatory, olfactory, and vestibular stimuli, in the same environment and where therapeutic guidance and commands are not given to the individual. These interventions aim to reduce agitation, depression, and aggression in individuals and increase daily living activities, functional performance, and well-being. Psychiatric clinics, schools, rehabilitation centers, and occupational therapy clinics are some places where it is used. Some materials found in Snoezelen rooms are bubble tubes, fiber optic light cables, projectors, vibrating massagers, light tactile stimulation materials, aromatic scent emitting devices, music sets, and relaxing music and swings.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
kızılcahamam Health Services Vocational School
Ankara, Kızılcahamam, 06890, Turkey (Türkiye)
Related Publications (6)
Anderson K, Bird M, Macpherson S, McDonough V, Davis T. Findings from a pilot investigation of the effectiveness of a snoezelen room in residential care: should we be engaging with our residents more? Geriatr Nurs. 2011 May-Jun;32(3):166-77. doi: 10.1016/j.gerinurse.2010.12.011. Epub 2011 Feb 9.
PMID: 21306798BACKGROUNDBishir M, Bhat A, Essa MM, Ekpo O, Ihunwo AO, Veeraraghavan VP, Mohan SK, Mahalakshmi AM, Ray B, Tuladhar S, Chang S, Chidambaram SB, Sakharkar MK, Guillemin GJ, Qoronfleh MW, Ojcius DM. Sleep Deprivation and Neurological Disorders. Biomed Res Int. 2020 Nov 23;2020:5764017. doi: 10.1155/2020/5764017. eCollection 2020.
PMID: 33381558BACKGROUNDKrakowiak P, Goodlin-Jones B, Hertz-Picciotto I, Croen LA, Hansen RL. Sleep problems in children with autism spectrum disorders, developmental delays, and typical development: a population-based study. J Sleep Res. 2008 Jun;17(2):197-206. doi: 10.1111/j.1365-2869.2008.00650.x.
PMID: 18482108BACKGROUNDMazurek MO, Sohl K. Sleep and Behavioral Problems in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Jun;46(6):1906-1915. doi: 10.1007/s10803-016-2723-7.
PMID: 26823076BACKGROUNDReynolds AM, Malow BA. Sleep and autism spectrum disorders. Pediatr Clin North Am. 2011 Jun;58(3):685-98. doi: 10.1016/j.pcl.2011.03.009.
PMID: 21600349BACKGROUNDSullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.
PMID: 23997866BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
November 30, 2023
First Posted
December 11, 2023
Study Start
June 1, 2023
Primary Completion
August 1, 2023
Study Completion
September 1, 2023
Last Updated
December 14, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
I don't want the results to be interpreted