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

NCT05376007 | Completed

• 1 other identifier: NL79852.029.22
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

siblings; visual impairment; intellectual disability; quality of life; well-being

Outcome Measures

Primary Outcomes (2)

• Change in quality of life as assessed by the Psychosocial Health Summary Score of the Pediatric Quality of Life Inventory (PedsQL 4.0) - Acute Version -

  The quality of life of the participating sibling is measured with both a child-report and parent-report version of the questionnaire Pediatric Quality of Life Inventory (PedsQL 4.0) - Acute Version - Psychosocial Health Summary Score. The total score on this scale has a minimum of 0 and a maximum of 60, with a higher score indicating more problems, and thus lower quality of life. The change in score over time on this outcome is measured, with a decreased score indicating improved quality of life.

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

• Change in Sibling adjustment to and perceptions of their brother or sister's disability

  Sibling adjustment to and perceptions of their brother or sister's disability is measured with both a child-report and parent-report version of the Sibling Perception Questionnaire (SPQ) - Negative Adjustment Scale. The total score on this scale has a minimum of 18 and a maximum of 72, with a higher score indicating more negative adjustment to the disability of the brother or sister. The change in score over time on this outcome is measured, with a decreased score indicating improved adjustment.

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

Secondary Outcomes (9)

• Change in Self-esteem

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

• Change in Perceived social support

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

• Change in sibling relationship (child-report)

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

• Change in sibling relationship (parent-report)

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

• Change in coping skills

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

Other Outcomes (1)

• Change in Parenting self-efficacy as assessed by a 3-item version of the Parenting Sense of Competence Scale (PSOC)

  pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)

Study Arms (2)

Playing serious game 'Broodles'

EXPERIMENTAL

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.

Behavioral: Serious game 'Broodles'

Waitlist control group

NO INTERVENTION

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.

Interventions

Serious game 'Broodles' 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.

Playing serious game 'Broodles'

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

VU University Amsterdam

Amsterdam, North Holland, 1081BT, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37198687 DERIVED

MeSH Terms

Conditions

Vision Disorders; Intellectual Disability

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Paula S Sterkenburg, prof. dr.

  VU University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators will be masked at pre-test assessment only
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed professor

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 17, 2022
• Study Start: April 22, 2022
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The study protocol, including the statistical analysis plan, will be published in Trials (date unknown). The informed consent form, full study protocol and analytic code can be shared upon reasonable request.
• Access Criteria: To be determined

Locations

NL (1)