NCT06164210

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

November 30, 2023

Last Update Submit

December 8, 2023

Conditions

Keywords

autismbehavioral problemsleep disordersensory integrationMulti-sensory room

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

EXPERIMENTAL

Conventional 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.

Behavioral: Snoezelen-Based Occupational Therapy Intervention Group

Snoezelen-Based Occupational Therapy Group

ACTIVE COMPARATOR

Snoezelen- 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.

Behavioral: Snoezelen-Based Occupational Therapy Intervention Group

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.

Also known as: Snoezelen, multi-sensory
Snoezelen-Based Occupational Therapy GroupTraditional Sensory Integration Intervention Group

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kızılcahamam Health Services Vocational School

Ankara, Kızılcahamam, 06890, Turkey (Türkiye)

Location

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: 21306798BACKGROUND
  • Bishir 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: 33381558BACKGROUND
  • Krakowiak 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: 18482108BACKGROUND
  • Mazurek 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: 26823076BACKGROUND
  • Reynolds 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: 21600349BACKGROUND
  • Sullivan 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

Autism Spectrum DisorderSleep Wake DisordersMental DisordersAutistic DisorderProblem Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorChild Behavior

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

Locations