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

February 28, 2023 updated by: Ingrid Larsson, RN, PhD, Associated Professor, Halmstad University

SLEEP - An Intervention With Weighted Blankets for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Sleep Problems

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is limited evidence about health outcomes or health-economic benefits of sleep interventions with weighted blankets for children with neuropsychiatric syndromes (NPS).

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 participants, n=100 children between 6 and 13 years old, will be recruited from the ADHD unit in Child and Adolescent Mental Health Service (CAMHS) and randomly assigned into two groups: Fiber Weighted Blankets (intervention 1) and Control Blankets (controls).

The children will use each blanket respectively for 4 weeks, then change blankets. A long term follow-up will be conducted 16 weeks from baseline.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Halmstad, Sweden, 30118
        • Halmstad University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Weighted fiber blanket
Using a weighted blanket
Using weighted blanket for four weeks
Placebo Comparator: Regular fiber blanket
Using a specially designed fiber blanket without extra weight.
Using weighted blanket for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: 1 week
objectively measured with actigraph during one week
1 week
Sleep onset latency
Time Frame: 1 week
objectively measured with actigraph during one week
1 week
Wake after sleep onset
Time Frame: 1 week
objectively measured with actigraph during one week
1 week
Total sleep time
Time Frame: 1 week
objectively measured with actigraph during one week
1 week
Self-reported sleep (Parental reported)
Time Frame: 1 week
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
Time Frame: 1 week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' Health related quality of life
Time Frame: 1 day
Assessed by EQ5D (among the parents), referring to this day. measuring the parents' health comprising five dimensions; 1) Mobility, 2) Self-care, 3) Usual activities, 4) Pain/discomfort, and 5) Anxiety/Depression. Each dimension is divided into three levels; No problems, Some or moderate problems, and extreme problems. In addition to the five dimensions, a 100-millimeter vertical Visual Analog Scale with endpoints of 100 means "best imaginable health state" and 0 means "worst imaginable health state is included. The total score ranges from 0 to 1 where a higher score indicates a better health-related quality of life.
1 day
Children's Health related quality of life
Time Frame: 1 day
Assessed by EQ5D-y (among the children), referring to this day, comprises five items; 1) Walking about (mobility), 2) Looking after myself (self-care), 3) Doing usual activities (usual activities), 4) Having pain or discomfort (pain and discomfort), and 5) Feeling worried, sad or unhappy (anxiety and depression). Each item is divided into three levels; No problems, Some problems, and A lot of problems. The EQ-5D-Y also includes an easily understandable modified vertical Visual Analogue Scale of EQ-5D, where the respondent rates the overall health status with the endpoints from 0 (the worst health state the child can imagine and 100 (the best health state the child can imagine)
1 day
Children's general well-being
Time Frame: 1 day
Assessed by Child Outcome Rating Scale (CORS), among the children, comprises four items where the child evaluates; 1) Me (How am I doing?), 2) Family (How are things in my family?), 3) School (How am I doing at school?), 4) Everything (How is everything going?). Each item is rated on a 100-millimeter Visual Analog Scale with smiling and sad faces as anchors.
1 day
Parent general well-being
Time Frame: 1 day
Assessed by Outcome Rating Scale (ORS), among the parents assessment of the past week in four items; 1) Personal wellbeing, 2) Interpersonal relationships, 3) Social relations and, 4) Overall sense of well-being. Each item is rated on a 100-millimeter Visual Analog Scale with anchors from 0 (negative) to 100 (positive).
1 day
Anxiety
Time Frame: 1 day
Assessed by short State-Trait Anxiety Inventory for children (short-STAI), includes six items.41 Each item is rated on a four-point Likert scale ranging with 1 = "not at all," 2 = "somewhat," 3, = "moderately", and 4 = "very much." The total score range from 6 to 24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety.
1 day
ADHD symptoms
Time Frame: 1 week
Assessed by The Swanson, Peland, and Nolan Scale (SNAP-IV), consists of 30 items and is divided into three subscales: inattention (nine items), hyperactivity/impulsivity (nine items), and oppositionality (eight items) and four supplementary questions regarding oppositionality (two questions) and ADHD (two questions). Items are rated on a four-point Likert scale range 0 = "not at all", 1 = "just a little", 2 = "quite a bit", and 3 = "very much". Items for inattention and hyperactivity/impulsivity can be combined to create a "combined ADHD" score.43 Higher scores represent more symptoms.
1 week
Family situation and parental mood
Time Frame: 1 week
Assessed by Brief Child and Family Phone Interview (BCFPI), consists of 36 symptom items and another 36 items to assess function, adversity, and family stress grouped into 12 subscales. The subscale ´family situation' contains three items rated on a four-point Likert scale range 1 = never, 2 = sometimes, 3 = often, 4 =always. The subscale ´parental mood' contains six items based on the question "How often during the past week has the parent experienced…?" rated on a four-point scale; < 1 day, 1-2 days, 3-4 days, >5 days.
1 week
Cost effectiveness
Time Frame: 4 week
Assessed by health economic aspects, such as absence from work, productivity, contact with health-care last four weeks
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ingrid Larsson, PhD, Halmstad University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disturbance

Clinical Trials on Weighted fiber blanket

3
Subscribe