An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems

NCT04180189 | Completed

• 1 other identifier: 1SLEEP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness. The study is an RCT with cross-over design. The participants will be randomized to start with an active or placebo blanket, and then change blankets during the 16 week study period.

Conditions

Adhd; Sleep Disturbance

Keywords

children; non-pharmacological intervention; ADHD; sleep

Outcome Measures

Primary Outcomes (6)

• Sleep efficiency

  objectively measured with actigraph during one week

  1 week

• Sleep onset latency

  objectively measured with actigraph during one week

  1 week

• Wake after sleep onset

  objectively measured with actigraph during one week

  1 week

• Total sleep time

  objectively measured with actigraph during one week

  1 week

• Self-reported sleep (Parental reported)

  Subjectively measured sleep problems in smaller children, assessed by Child's Sleep Habits Questionnaire (CSHQ), assessed by the parents, referring to last week. consists of 33 items related to eight subscales; 1) Bedtime resistance, 2) Sleep onset delay, 3) Sleep duration, 4) Sleep anxiety, 5) Night wakings, 6) Parasomnias, 7) Sleep-disordered breathing, and 8) Daytime sleepiness. Each item is rated on a three-point scale: "usually" if the sleep behavior occurred five to seven times/week; "sometimes" for two to four times/week; and "rarely" for zero to one time/week. A higher score indicates more sleep problems

  1 week

• Self-reported sleep

  Subjectively measured sleep problems in children, assessed by Insomnia Severity Index (ISI), children responding, referring to last week, comprises seven items for the children to respond to: 1) Severity of sleep-onset, 2) Sleep maintenance, 3) Early morning awakening, 4) Satisfaction with current sleep pattern, 5) Interference with daily functioning, 6) Noticeability of impairment attributed to the sleep problem, and 7) Level of distress caused by the sleep problem. Each item is rated on a five-point Likert scale ranging from "not at all" (scored at 0) to "extremely" (scored at 4). Total score ranges from 0 to 28, with higher scores indicating greater severity.

  1 week

Secondary Outcomes (8)

• Parents' Health related quality of life

  1 day

• Children's Health related quality of life

  1 day

• Children's general well-being

  1 day

• Parent general well-being

  1 day

• Anxiety

  1 day

Study Arms (2)

Weighted fiber blanket

ACTIVE COMPARATOR

Using a weighted blanket

Other: Weighted fiber blanket

Regular fiber blanket

PLACEBO COMPARATOR

Using a specially designed fiber blanket without extra weight.

Other: Weighted fiber blanket

Interventions

Weighted fiber blanket OTHER

Using weighted blanket for four weeks

Regular fiber blanket; Weighted fiber blanket

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with ADHD with sleep problems (defined by screening instrument). -
• Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
• Parents and children should understand (written and spoken) Swedish language.

You may not qualify if:

• Already used weighted blankets as a sleep intervention,
• If they have received a new prescription or change of pharmacological treatment for sleep problems

Sponsors & Collaborators

• Halmstad University: lead

Study Sites (1)

Halmstad University

Halmstad, 30118, Sweden

Location

Related Publications (1)

• Larsson I, Aili K, Nygren JM, Johansson P, Jarbin H, Svedberg P. SLEEP: intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: study protocol for a randomised control trial. BMJ Open. 2022 Jan 4;12(1):e047509. doi: 10.1136/bmjopen-2020-047509.

  PMID: 34983749 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ingrid Larsson, PhD

  Halmstad University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Associate professor

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: January 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)