Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children

NCT06260020 | Not Yet Recruiting DMC

• 1 other identifier: IECPG-463/24.08.2023
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sleep disorder in autism children is common and it affects the physical, behavior and mental health. There is lack of comprehensive management program/module to treat the sleep disorders in children with ASD. Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present. Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders, so as to improve the behavioral outcomes as well. This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities.

Conditions

Sleep Disorder; Autism Spectrum Disorder; Polysomnography; Actigraphy; Children; Behavior Therapy

Keywords

ASD; PSG; CSHQ; Actigraphy; sleep

Outcome Measures

Primary Outcomes (4)

• Development of comprehensive module for management of sleep disorders in autism spectrum disorders

  The comprehensive module will be developed for management of sleep disorders. The proposed components in the module are Behavioral intervention like modifying stimulus by change in location of sleep onset,Giving schedule activities which interfere with sleep before bedtime,Using a bedtime pass which allows children to make a predetermined number of requests for parental attention while in bed,Giving sleep items,Delaying the bedtime,Sleep hygiene by providing suitable environment for child to sleep, providing proper bedtime routine , sleep wake schedules,Providing rewards as positive reinforcement.Pharmacological intervention to treat them accordingly as per standard protocol available,The components of the module will be decided based on Delphi method. Experts opinion will be taken and comprehensive module will be developed accordingly.

  3 months from onset of study

• To validate the above module in children of ASD with sleep disorders by measuring change in Children's Sleep Habits Questionnaire(CSHQ) score pre and post intervention.

  The CSHQ is a parent-rated questionnaire comprised of 45 items; 33 scored questions, and 7 additional items intended to provide other relevant information pertaining to sleep behavior (e.g., nocturnal body pains) Each scored question is rated on a 3-point scale as occurring "usually" (i.e., 5-7 times within the past week), "sometimes" (i.e., 2-4 times within the past week), or "rarely" (i.e., never or 1 time within the past week). A number of items on the questionnaire are reverse-scored, so that higher scores consistently indicate problem behaviors. Ratings are combined to form eight subscales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep Disordered Breathing, and Daytime Sleepiness. A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99.

  From baseline to 6 months

• To validate the above module in children of ASD with sleep disorders by comparing sleep efficiency

  Change in sleep efficiency (%) as measured by PSG and actigraphy pre and post intervention.

  From baseline to 6 months

• To validate the above module in children of ASD with sleep disorders by comparing change in sleep onset latency

  Change in sleep onset latency(time duration)as measured by PSG and actigraphy pre and post intervention.

  From baseline to 6 months

Secondary Outcomes (8)

• To evaluate the agreement of actigraphy with polysomnography in sleep efficiency for evaluation of sleep disorders in children with autism spectrum disorder

  6 months

• Change in autism severity using ATEC (Autism treatment evaluation checklist) score

  6 months

• To evaluate the agreement of actigraphy with polysomnography in determining sleep onset latency duration for evaluation of sleep disorders in children with autism spectrum disorder

  6 months

• Change in autism severity using CBCL (child behavior checklist) behavioral scales.

  6 months

• Change in autism severity using CARS-2(childhood autism rating scale -2).

  6 months

Study Arms (1)

Children [4-10 years] with ASD with sleep disorder

EXPERIMENTAL

Development of module by Delphi method:components of Module include Behavioural intervention Modifying stimulus by change in location,using bedtime stories. Giving schedules to activities which interfere with sleep before bedtime. Using a bedtime pass to allow child to make a prefixed number of requests for parental attention while in bed. Giving sleep items like cuddle toys to replace parental presence. Gradually delaying the bedtime so the child feels urge to sleep. Sleep hygiene by providing suitable environment to sleep, proper bedtime routine, sleep wake schedules Providing rewards for following good bedtime routine as positive reinforcement. Pharmacological intervention Sleep disorders due to underlying ENT, pulmonary conditions, to be treated as per standard protocol Usage of melatonin if required for sleep onset difficulty An 80%agreement over an intervention will be included in the module

Behavioral: Comprehensive module for management of sleep disorders[Behavioral and pharmacological therapy]

Interventions

Comprehensive module for management of sleep disorders[Behavioral and pharmacological therapy] BEHAVIORAL

Development of module by Delphi method:components of Module include Behavioural intervention Modifying stimulus by change in location,using bedtime stories. Giving schedules to activities which interfere with sleep before bedtime. Using a bedtime pass to allow child to make a prefixed number of requests for parental attention while in bed. Giving sleep items like cuddle toys to replace parental presence. Gradually delaying the bedtime so the child feels urge to sleep. Sleep hygiene by providing suitable environment to sleep, proper bedtime routine, sleep wake schedules Providing rewards for following good bedtime routine as positive reinforcement. Pharmacological intervention Sleep disorders due to underlying ENT, pulmonary conditions, to be treated as per standard protocol Usage of melatonin if required for sleep onset difficulty An 80%agreement over an intervention will be included in the module

Children [4-10 years] with ASD with sleep disorder

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-10 years with diagnosis of ASD and ICSD based sleep disorder
• At-least 6 months of behavioral therapy and follow-up at AIIMS

You may not qualify if:

• Refractory epilepsy
• Secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis
• ASD with metabolic disorders

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Sleep Wake Disorders; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Sheffali Gulati, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati, MD

CONTACT

01126594679; sheffaligulati@gmail.com

Sheffali Gulati, MD

CONTACT

9810386847; sheffaligulati1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pre and post intervention study

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 15, 2024
• Study Start: February 20, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share