Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06403969 |
| Other study ID # |
281174 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 14, 2024 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Värmland County Council, Sweden |
| Contact |
Sverre Wikström, Assoc Prof |
| Phone |
+46703456327 |
| Email |
sverre.wikstrom[@]regionvarmland.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. N=15 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.
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 child's
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.
