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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240105060616N1
Enrollment
30
Registered
2024-02-12
Start date
2024-05-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder. Autistic disorder

Interventions

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 wit

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Asadi

Iran University of Medical Sciences

siminasadi.ot@gmail.com+98 21 5547 6212

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026