HealthyNCT05376007
Effectiveness of the Serious Game 'Broodles' for Siblings of Children With Visual Impairment and/or Intellectual Disability
A study testing Serious game 'Broodles' in people with Healthy, run by VU University of Amsterdam at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Serious game 'Broodles'
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Apr 2022to 6 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Amsterdam
Amsterdam, North Holland, 1081BT
About this study
Official title: The Effectiveness of the Serious Game 'Broodles' in Improving Psychosocial Well-being of Siblings (6-9 Years Old) of Children With Visual Impairment and/or Intellectual Disability: A Randomized Controlled Trial
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.
Read the detailed description
A detailed description can be found in the published protocol in Trials.
- Conditions
- Healthy
- Being tested
- Serious game 'Broodles'
- Keywords
- siblings, visual impairment, intellectual disability, quality of life, well-being
- Medical subject headings
- Vision Disorders, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game 'Broodles'Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Secondary outcomes (9)
Change in Self-esteem
The self-esteem of the sibling is measured with the child-report questionnaire Self-Perception Profile for Children simplified(SPPC-s) - Global Self-Worth subscale. The total score on this scale has a minimum of 3 and a maximum of 12, with a higher score indicating higher self-esteem. The change in score over time on this outcome is measured, with an increased score indicating improved self-esteem.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in Perceived social support
The perceived social support of the participating sibling is measured with the child-report questionnaire Social Support Scale for Children (SSSC). The total score on this scale has a minimum of 24 and a maximum of 96, with a higher score indicating higher perceived social support. The change in score over time on this outcome is measured, with an increased score indicating improved perceived social support.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in sibling relationship (child-report)
Sibling relationship between the participating sibling and the sibling that has a disability is measured with the child-report drawing task Pictorial Assessment of Interpersonal Relationships (PAIR). This instrument has six separate scales.
The scales Cohesion and Distancing have total score ranges from 0 to 6, with a higher score indicating respectively higher interdependence and higher autonomy in the relationship.
The scales Similarity and Value have total score ranges from 0 to 10, with a higher score indicating respectively higher affinity and higher disparity between the siblings.
The scales Emotion and Conflict have nominal and ordinal scores (1-4), with a higher score indicating respectively more similarity in emotional state and a amore disrupted relationship.
The change in score over time on this outcome is measured. In addition thematic analysis is executed, and changes in themes over time are measured.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in sibling relationship (parent-report)
Sibling relationship between the participating sibling and the sibling that has a disability is measured with the parent-report questionnaire Parental Expectations and Perceptions of Children's Sibling Relationships Questionnaire (PEP-SRQ). This scale has three separate subscales.
These include the scales Warmth (total score ranges from 15 to 80), Agonism (total score ranges from 9 to 45), and Rivalry/Competition (total score ranges from 3 to 15). A higher score indicates respectively more warmth, more agonism, and more rivalry in the sibling relationship as perceived by the parent.
The scale also has a question about the total quality of the sibling relationship, as perceived by the parent (range 1-7), with a higher score indicating higher quality of the relationship.
The change in score over time on this outcome is measured.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in coping skills
Copings skills of the participating sibling are measured with a 12-item version of the child-report questionnaire Coping Strategies Inventory (CSI).Two separate subscales are used: Engaged and Disengaged Coping. The total score on both scales have a minimum of 5 and a maximum of 30. A higher scored on the Engaged scale means higher use of engaged coping strategies. A higher score on the Disenganged scale means higher use of disengaged coping strategies. The baseline change in scores over time on this outcome is measured.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in parent-child relationship
The parent-child relationship between the participating sibling and the participating parent is measured with the parent-report questionnaire Child-Parent Relationship Scale (CPRS) - Closeness scale, short version.
The total score on this scale has a minimum of 7 and a maximum of 35, with a higher score indicating a closer parent-child relationship. The change in score over time on this outcome is measured.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Social validity of the intervention
The social validity of the intervention is measured with an adapted version of the child-report and parent-report questionnaire Social Validity Scale (SVS). The mean score on the scale, ranging from 1 to 5, will be used.
Measured: post-test (T1, week 6; only group 1)
Subjective evaluation of the intervention
Participants (both parents and children) answer open-ended evaluation questions about the intervention at post-test assessment. This includes questions about what they think was good about the intervention, what they think could be better, and what they think they learned from the intervention.
Measured: post-test (T1, week 6; only group 1)
Change in Sibling adjustment to their brother or sister's disability
Sibling adjustment to their brother or sister's disability is measured with self-developed open ended questions that are answered by the parent and the child. The questions include: (1) "Can you name up to five examples of what you/your child like(s)about your/their brother or sister?" (2) "Can you name up to five examples of what you/your child do(es)not like or find(s)difficult or unpleasant about having a brother or sister with a disability?" (3) "Can you explain what you/your child do(es)to deal with these examples?" The children are also asked to rate the examples named at question 1 and question 2 with smileys (5-point scale), indicating how much they like it or how hard they think it is.
Thematic analysis is executed, and changes in themes over time are measured. Change over time in smileys is measured as well.
Measured: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start22 Apr 2022
- Primary completion6 Apr 2024
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Paula S. Sterkenburg, VU University of Amsterdam
- Investigators
- Paula S Sterkenburg, prof. dr., Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376007
- Sponsor's protocol ID
- NL79852.029.22
- Other IDs
- NL79852.029.22
- Status last verified
- May 2024
- First submitted
- 21 Apr 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized quantitative IPD of the participants that gave additional consent, will be shared with other researchers upon reasonable request. This includes the scores on the following questionnaires: PedsQL, SPQ, SPPC, SSSC, CSI, CPRS and PSOC.
Publications
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.
PubMed 37198687
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Serious Game 'Broodles' in Improving Psychosocial Well-being of Siblings (6-9 Years Old) of Children With Visual Impairment and/or Intellectual Disability: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05376007
- Acronym / sponsor ID
- NL79852.029.22
- Conditions
- Healthy
- Keywords
- siblings, visual impairment, intellectual disability, quality of life, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 6 Apr 2024 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
A detailed description can be found in the published protocol in Trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Playing serious game 'Broodles' | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Playing serious game 'Broodles' |
Primary outcome
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 -
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
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.
Change in Sibling adjustment to and perceptions of their brother or sister's disability
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
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.
9 secondary outcomes
Change in Self-esteem
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in Perceived social support
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in sibling relationship (child-report)
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in sibling relationship (parent-report)
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in coping skills
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Change in parent-child relationship
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Social validity of the intervention
Time frame: post-test (T1, week 6; only group 1)
Subjective evaluation of the intervention
Time frame: post-test (T1, week 6; only group 1)
Change in Sibling adjustment to their brother or sister's disability
Time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 37198687Veerman 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.
- Individual participant dataSharing planned: Yes. Anonymized quantitative IPD of the participants that gave additional consent, will be shared with other researchers upon reasonable request. This includes the scores on the following questionnaires: PedsQL, SPQ, SPPC, SSSC, CSI, CPRS and PSOC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula S Sterkenburg, prof. dr. principal investigator
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game 'Broodles' in people with Healthy, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 - (time frame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05376007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.