Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-10
Brief Title:
Sleep in Children With Autism and Intellectual Disability
Sponsor:
Värmland County Council Sweden
Organization:
Värmland County Council Sweden
Study Overview
Official Title:
SLEEP - in Children With Autism and Intellectual Disability Investigation and Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEP-AID IT
Brief Summary:
Purposes Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined To explore the diagnostic yield of polysomnography for these individuals To examine the feasibility and treatment effect of Applied Behavior Analysis ABA for insomnia focusing on sleep maintenance difficulties in these children
Method Single-case experimental design with multiple baselines and with multiple participants with a focus on feasibility N15 prepubertal children aged 6-12 years with autism and intellectual disabilities combined and difficulties in maintaining nighttime sleep Assessment with home polysomnography actigraphy Intervention with ABA including functional analysis measurable goals and behavior modification based on the functional analysis Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment Feasibility is examined as adherence to assessment and treatment as well as in a qualitative study of parental experiences
Method Single-case experimental design with multiple baselines and with multiple participants with a focus on feasibility N15 prepubertal children aged 6-12 years with autism and intellectual disabilities combined and difficulties in maintaining nighttime sleep Assessment with home polysomnography actigraphy Intervention with ABA including functional analysis measurable goals and behavior modification based on the functional analysis Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment Feasibility is examined as adherence to assessment and treatment as well as in a qualitative study of parental experiences
Detailed Description:
Pilot study with a feasibility focus using a single-case experimental design employing multiple baselines and involving multiple participants Children aged 6-12 with autism and intellectual disabilities along with sleep maintenance difficulties are recruited Following diagnostic assessment of insomnia up to two weeks of sleep registration using sleep diaries and actigraphy is initiated Polysomnography will be used to identify characterize and map out the sleep disorder Registration is conducted at home over one night and supplemented with a home visit If no significant physiological explanations are discovered treatment with Applied Behavior Analysis ABA conducted by a psychologist is then commenced The intervention begins with goal formulation Subsequently a functional analysis is carried out to analyze the underlying function of a behavior contributing to and maintaining the sleep disorder This assessment follows the ABC model and is based on clinical interviews observations sleep diaries and actigraphy Next a treatment plan with measurable goals and strategies to achieve them is formulated Interventions are based on both antecedents and consequences with a strong emphasis on positive reinforcement of favorable sleep behaviors Overall the intervention is individualized and most treatment components from cognitive behavioral therapy may be relevant Examples include education in sleep hygiene changes in the sleep environment and positive reinforcement of favorable behaviors Stimulus control techniques such as going to bed when tired and establishing good bedtime routines with visual support are included Sleep restriction limiting naps and bedtime fading are also part of the intervention Modified extinction techniques with parental presence may be applied especially if co-sleeping is problematic gradually phasing out immediate parental presence in or near the bed while remaining responsive to the childs need for security with a clear intention to cease co-sleeping The intervention continues until treatment goals are achieved or for a maximum of eight sessions up to 60 minutes each spread over a maximum of eight weeks Sleep diaries are continued daily throughout the study period including up to two weeks after the intervention ends Actigraphy registration is restarted one week after the intervention ends and continues for the same duration as during the baseline registration Sleep diaries are also recorded in the same manner for a follow-up three months after the intervention ends
Primary outcomes are change from baseline to follow up one week after completed intervention regarding Total Sleep Time TST Wakefulness After Sleep Onset WASO and frequency of night-time awakenings based on actigraphy Secondary outcomes are change from baseline to follow up regarding TST WASO night-time awakenings and sleep efficiency based on sleep diaries Specified outcome is also feasibility of investigation and intervention as below
Feasibility of the sleep assessment including polysomnography is evaluated in terms of frequency and proportion of completed assessments as well as parental acceptance of the assessment in the qualitative component below Method adaptation needs are described The diagnostic yield of the assessment is reported patient by patient and summarized with a hypothesis-generating approach Parents experiences of the intervention and its feasibility are qualitatively explored and described The interview is semi-structured conducted one month after the intervention ends and analyzed using qualitative content analysis Feasibility of the ABA intervention is also evaluated in terms of frequency of completed treatments therapist ratings of families adherence to treatment intervention duration and therapists adherence to the study protocol
Primary outcomes are change from baseline to follow up one week after completed intervention regarding Total Sleep Time TST Wakefulness After Sleep Onset WASO and frequency of night-time awakenings based on actigraphy Secondary outcomes are change from baseline to follow up regarding TST WASO night-time awakenings and sleep efficiency based on sleep diaries Specified outcome is also feasibility of investigation and intervention as below
Feasibility of the sleep assessment including polysomnography is evaluated in terms of frequency and proportion of completed assessments as well as parental acceptance of the assessment in the qualitative component below Method adaptation needs are described The diagnostic yield of the assessment is reported patient by patient and summarized with a hypothesis-generating approach Parents experiences of the intervention and its feasibility are qualitatively explored and described The interview is semi-structured conducted one month after the intervention ends and analyzed using qualitative content analysis Feasibility of the ABA intervention is also evaluated in terms of frequency of completed treatments therapist ratings of families adherence to treatment intervention duration and therapists adherence to the study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None