]>
IRCT20240105060616N1 IRCT 2024-02-12 Iran University of Medical Sciences Developing a sleep guide for child with autism spectrum disorder and investigating its efficacy on sleep and Severity of symptoms in children with autism spectrum disorder Developing a «sleep guide for child with autism spectrum disorder for parents with emphasis on self-regulation strategies in occupational therapy » and investigating its efficacy on sleep and Severity of symptoms in children with autism spectrum disorder aged 6 to 12 years old: Randomized Clinical Trial 2024-05-21 anticipated 30 Complete https://irct.ir/trial/75270 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, we use the randomization list of the investigated samples in the intervention and control groups and by lottery (tossing a coin), the letter A or B will be considered for the samples of the intervention group and the control group. It is worth mentioning that in the two intervention and control groups, matching is done in terms of the level of autism, Blinding description: The person who scores the outcome assessments and then enters them into the SPSS software is blind. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: After designing and developing the manual with emphasis on self-regulation strategies for children with ASD aged 6 to 12 years based on the texts and compliance with OTPF and the "child-environment- sleep occupation" model, the research objectives are explained for the main caregivers of children with ASD. Then the demographic form will be completed. In the demographic form, the common occupational therapy treatment plan will be reported, and actions that directly or indirectly overlap or interfere with sleep interventions will be identified and controlled. Then the pre-tests (ATEC, SPM-2, CSHQ, PSI-SF, BRIEF) will be conducted in schools or autism centers or in the clinic of the rehabilitation faculty of Iran University of Medical Sciences, in the middle of the Season(so that the change of season does not affect the child's sleep). In the intervention group, SSP-2 will also be completed in order to determine the sensory needs of children with ASD in order to determine which part of the draft protocol to be taught to the family. Also, in the intervention group, a video or photo of the child's sleeping environment will be prepared by the family and matched with the "Child and Adolescent Sleeping Environment Scale" (CASES) so that environmental modifications in each child's sleeping environment can be considered if needed. Then, the content of the booklet will be taught to the main caregivers of the children in special sessions for implementation at home. In these sessions, according to the child's age, the child's sleeping environment, his sensory needs, and other conditions related to the child's home and family, some items in the booklet will be explained to the main caregiver. Then the intervention at home will be implemented by the main caregiver based on similar studies for 8 weeks. During this period, by using the Log Book, the family's loyalty to the implementation of the items taught in the meetings and the manual at home will be recorded by the main caregiver, and parents' feedback will be received and examined by weekly phone calls. At this stage, the MPOC-20 form will be completed monthly by the main caregiver of the child in order to check the views of the parents regarding the services provided by the researchers, and in this way, we will check the opinion of the main caregivers regarding the interventions. Also, in order to monitor children's sleep more accurately, the Sleep Diary will be completed daily by the main caregiver. Conducting secondary evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again in autism centers or in the clinic of the rehabilitation faculty of Iran University of Medical Sciences in the middle of the year. Conducting follow-up evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again 8 weeks after the end of the intervention. Intervention 2: Control group: After explaining the objectives of the research for the main caregivers of children with ASD, the demographic form will be completed. In the demographic form, the common occupational therapy treatment plan will be reported, and actions that directly or indirectly overlap or interfere with sleep interventions will be identified and controlled. Then the pre-tests (ATEC, SPM-2, CSHQ, PSI-SF, BRIEF) will be performed in the control group in schools or autism centers or in the clinic of the Rehabilitation Faculty of Iran University of Medical Sciences, in the middle of the Season (so that the change of season does not affect the child's sleep). Also, in order to monitor children's sleep more accurately, Sleep Diary will be completed daily by the main caregiver. Participants in the control group will receive common occupational therapy interventions provided in centers or schools, including cognitive or educational interventions, or social interventions, etc. Performing secondary evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again in autism centers or in the clinic of the rehabilitation faculty of Iran University of Medical Sciences in the middle of the season. Conducting follow-up evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again 8 weeks later. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The analysis of the results will be reported in the form of an article.
public Simin Asadi
No. 8; Hoveyda Alley; Shahid Mahloji Qomi St; Molvi St
Tehran Iran (Islamic Republic of) 1196683311 +98 21 5547 6212 siminasadi.ot@gmail.com Iran University of Medical Sciences scientific Samauneh Karamali Esmaeili
Faculty of Rehabilitation Sciences; Iran University of Medical Sciences; Shah Nazari St.; Madadkaran St.; Mader Square; Mirdamad; Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 samauneh.esmaeili@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria for parents: being able to read and write; Having complaint about sleep problems in child with ASD; Willingness and declaration of readiness to cooperate with the researcher to implement the intervention at home; Availability of at least one parent who can continuously participate in educational and research activities. Children's inclusion criteria: having an ASD diagnosis by a child psychiatrist; The severity of autism according to the GARS test be at level 1 or 2; Obtaining a score higher than 41 in CSHQ; The child is in the age range of 6 to 12 years. Having at least 5 years of clinical and research experience in working with children with ASD; Having expertise related to children with ASD such as pediatric psychiatrist, pediatric occupational therapist, pediatric psychologist. 6 years 12 years Both Having a psychiatric disorder in the active phase, in the primary caregiver according to the SCID. Taking drugs that have the potential to induce sleep during the intervention and after 6 pm by the child (such as melatonin, benzodiazepines, antipsychotics such as haloperidol, olanzapine, risperidone, quetiapine, perphenazine, chlorpromazine, antidepressants such as imipramine, amitriptyline and clomipramine) The presence of severe medical problems in the child based on the medical record or as reported by the parents F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention group: After designing and developing the manual with emphasis on self-regulation strategies for children with ASD aged 6 to 12 years based on the texts and compliance with OTPF and the "child-environment- sleep occupation" model, the research objectives are explained for the main caregivers of children with ASD. Then the demographic form will be completed. In the demographic form, the common occupational therapy treatment plan will be reported, and actions that directly or indirectly overlap or interfere with sleep interventions will be identified and controlled. Then the pre-tests (ATEC, SPM-2, CSHQ, PSI-SF, BRIEF) will be conducted in schools or autism centers or in the clinic of the rehabilitation faculty of Iran University of Medical Sciences, in the middle of the Season(so that the change of season does not affect the child's sleep). In the intervention group, SSP-2 will also be completed in order to determine the sensory needs of children with ASD in order to determine which part of the draft protocol to be taught to the family. Also, in the intervention group, a video or photo of the child's sleeping environment will be prepared by the family and matched with the "Child and Adolescent Sleeping Environment Scale" (CASES) so that environmental modifications in each child's sleeping environment can be considered if needed. Then, the content of the booklet will be taught to the main caregivers of the children in special sessions for implementation at home. In these sessions, according to the child's age, the child's sleeping environment, his sensory needs, and other conditions related to the child's home and family, some items in the booklet will be explained to the main caregiver. Then the intervention at home will be implemented by the main caregiver based on similar studies for 8 weeks. During this period, by using the Log Book, the family's loyalty to the implementation of the items taught in the meetings and the manual at home will be recorded by the main caregiver, and parents' feedback will be received and examined by weekly phone calls. At this stage, the MPOC-20 form will be completed monthly by the main caregiver of the child in order to check the views of the parents regarding the services provided by the researchers, and in this way, we will check the opinion of the main caregivers regarding the interventions. Also, in order to monitor children's sleep more accurately, the Sleep Diary will be completed daily by the main caregiver. Conducting secondary evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again in autism centers or in the clinic of the rehabilitation faculty of Iran University of Medical Sciences in the middle of the year. Conducting follow-up evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again 8 weeks after the end of the intervention. Control group: After explaining the objectives of the research for the main caregivers of children with ASD, the demographic form will be completed. In the demographic form, the common occupational therapy treatment plan will be reported, and actions that directly or indirectly overlap or interfere with sleep interventions will be identified and controlled. Then the pre-tests (ATEC, SPM-2, CSHQ, PSI-SF, BRIEF) will be performed in the control group in schools or autism centers or in the clinic of the Rehabilitation Faculty of Iran University of Medical Sciences, in the middle of the Season (so that the change of season does not affect the child's sleep). Also, in order to monitor children's sleep more accurately, Sleep Diary will be completed daily by the main caregiver. Participants in the control group will receive common occupational therapy interventions provided in centers or schools, including cognitive or educational interventions, or social interventions, etc. Performing secondary evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again in autism centers or in the clinic of the rehabilitation faculty of Iran University of Medical Sciences in the middle of the season. Conducting follow-up evaluations: CSHQ, ATEC, SPM-2, PSI-SF and BRIEF evaluations will be done again 8 weeks later. Sleep. Timepoint: Before the intervention, After the intervention, At the follow-up time two months after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ). Severity of symptoms. Timepoint: Before the intervention, After the intervention, At the follow-up time two months after the intervention. Method of measurement: Autism Treatment Evaluation Checklist (ATEC). Severity of symptoms. Timepoint: Before the intervention, After the intervention, At the follow-up time two months after the intervention. Method of measurement: Sensory Processing Measure 2- child’s School form (SPM-2). Parent stress. Timepoint: Before the intervention, After the intervention, At the follow-up time two months after the intervention. Method of measurement: Parent Stress Index-Short form (PSI-SF). Executive Function. Timepoint: Before the intervention, After the intervention, At the follow-up time two months after the intervention. Method of measurement: Behaviour Rating Inventory of Executive Function-Parent version (BRIEF). Iran University of Medical Sciences Approved 2023-12-27 Ethics Committee of Iran University of Medical Sciences Unit 2, No. 8, Hoveyda Alley, Shahid Mahloji Qomi St, Molvi St. Tehran Tehran Iran (Islamic Republic of)