Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness

NCT ID: NCT06808425

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2034-02-28

Brief Summary

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The aim is to study a sleep intervention with weighted blankets in children with ADHD and sleep problems regarding 1) short- and long-term effects on sleep and health-related outcomes in comparison with standard treatment (melatonin), 2) barriers and facilitators to implementation in routine clinical practice, and 3) health-economic outcomes.

Detailed Description

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Conditions

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ADHD Sleep Disturbances Sleep Sleep Problems

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Weighted blanket

Group Type ACTIVE_COMPARATOR

Intervention A

Intervention Type DEVICE

Weighted blanket

Standard treatment (melatonin)

Group Type ACTIVE_COMPARATOR

Intervention B

Intervention Type DRUG

Standard treatment (melatonin)

Interventions

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Intervention A

Weighted blanket

Intervention Type DEVICE

Intervention B

Standard treatment (melatonin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children diagnosed with ADHD (DSM-5) and sleep problems (defined by screening instrument).
* Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halmstad University

OTHER

Sponsor Role lead

Responsible Party

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Ingrid Larsson, RN, PhD, Professor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Halmstad University

Halmstad, Halland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lena-Karin Erlandsson, PhD

Role: CONTACT

0046729773818

Ingrid Larsson, PhD

Role: CONTACT

0046729773722

Facility Contacts

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Ingrid Larsson, PhD

Role: primary

0046729773722

Julia S Malmborg, PhD

Role: backup

0046721784979

Other Identifiers

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F2024/38

Identifier Type: -

Identifier Source: org_study_id

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