Effectiveness of the Serious Game 'Broodles' for Siblings of Children With Visual Impairment and/or Intellectual Disability

NCT ID: NCT05376007

Last Updated: 2024-05-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2024-04-06

Brief Summary

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The support for siblings of children with disabilities is scarce and fragmented, even though studies have shown that these siblings can benefit from support. Although some interventions for siblings have been developed, these are costly and time-consuming and the effects have not been researched thoroughly with randomized controlled trials. This study will investigate the effectiveness of the newly developed serious game 'Broodles' in improving the quality of life and psychosocial well-being of healthy siblings (aged 6-9 years) of children with intellectual disability (ID) and/or visual impairment (VI). The effectiveness of the serious game will be examined in a randomized controlled trial (RCT) with a pre-test (T0), post-test (T1) and follow-up (T2). There will be two groups, namely an experimental group playing the serious game and a waitlist control group. Quantitative and qualitative measures will be used including questionnaires, drawings and open-ended questions. Both the sibling and one parent will complete the assessments.

The serious game, named 'Broodles', is a psychological intervention that addresses how to handle thoughts and emotions concerning several important issues in the lives of siblings. The game has 8 levels that take approximately 20 minutes to play. In addition to the serious game, children make offline worksheets and parents receive tips and information on how to support their child. The primary study parameters are quality of life and sibling adjustment to and perceptions of the disability of the brother or sister. Secondary study parameters are different aspects of psychosocial well-being, including self-esteem, experienced social support, sibling relationship, coping skills, parent-child relationship, and social validity. It is expected that the participants in the experimental conditions will benefit from playing the game, namely their quality of life and psychosocial well-being is expected to improve.

Detailed Description

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A detailed description can be found in the published protocol in Trials.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Participants and investigators will be masked at pre-test assessment only

Study Groups

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Playing serious game 'Broodles'

The participants allocated to this group will play the newly developed serious game 'Broodles' after pre-test assessment. Children will play the serious game without the parent or the help of a caregiver. Parents and children will make complementary worksheets together and parents will read an information brochure.

Concomitant care as usual is allowed during the study.

A parent-child pair is labelled as one participant.

Group Type EXPERIMENTAL

Serious game 'Broodles'

Intervention Type BEHAVIORAL

The serious game 'Broodles' is a newly developed web-based, educational game that can be played by siblings on a computer or tablet without support from an adult. The game discusses the nine domains of sibling quality of life (Moyson \& Roeyers, 2012) in eight 20-minute levels. The main characters of the game are the Broodles, which are little monster creatures that experience things that siblings of children with ID and/or VI can also experience. The game includes animations, videos of siblings talking about their experiences, quizzes and mini-games. These elements are focussed on emotions, thoughts and difficult situations that siblings can experience. In addition to the game, siblings make offline worksheets and parents receive an information brochure. Siblings complete the game in four weeks.

Waitlist control group

The participants allocated to this group will play the serious game 'Broodles' after follow-up assessment.

Concomitant care as usual is allowed during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Serious game 'Broodles'

The serious game 'Broodles' is a newly developed web-based, educational game that can be played by siblings on a computer or tablet without support from an adult. The game discusses the nine domains of sibling quality of life (Moyson \& Roeyers, 2012) in eight 20-minute levels. The main characters of the game are the Broodles, which are little monster creatures that experience things that siblings of children with ID and/or VI can also experience. The game includes animations, videos of siblings talking about their experiences, quizzes and mini-games. These elements are focussed on emotions, thoughts and difficult situations that siblings can experience. In addition to the game, siblings make offline worksheets and parents receive an information brochure. Siblings complete the game in four weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Having a brother or sister with (strongly suspected) visual impairment and/or intellectual disability (0-17;11years old), with possibly other comorbid disabilities, disorders or illnesses.
* The brother or sister with a disability lives in the same house (at least part of the time)
* Living in the Netherlands or Flanders (Dutch speaking part of Belgium)

Exclusion Criteria

* Having a disability, impairment or severe illness
* Brother or sister with VI and/or ID lives in a residential care facility on a full-time basis
* One or both parents have a disability, impairment or severe illness
* Not speaking the Dutch language
* No written consent from the participant and/or their legal representative
* Another sibling in the household is already included in the study. Only one sibling per household can participate in the study. The parents will decide which sibling will participate.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Paula S. Sterkenburg

Endowed professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula S Sterkenburg, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

VU University of Amsterdam

Locations

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VU University Amsterdam

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Veerman LKM, Willemen AM, Derks SDM, Brouwer-van Dijken AAJ, Sterkenburg PS. The effectiveness of the serious game "Broodles" for siblings of children with intellectual disabilities and/or visual impairment: study protocol for a randomized controlled trial. Trials. 2023 May 17;24(1):336. doi: 10.1186/s13063-023-07358-1.

Reference Type DERIVED
PMID: 37198687 (View on PubMed)

Other Identifiers

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NL79852.029.22

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL79852.029.22

Identifier Type: -

Identifier Source: org_study_id

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