Clinical trial NCT05376007: Effectiveness of the Serious Game 'Broodles' for Siblings of Children With Visual Impairment and/or Intellectual Disability
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: siblings
visual impairment
intellectual disability
quality of life
well-being
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 107
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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.

Primary outcomes:
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 -
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Change in Sibling adjustment to and perceptions of their brother or sister's disability
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Secondary outcomes:
measure: Change in Self-esteem
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Change in Perceived social support
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Change in sibling relationship (child-report)
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Change in sibling relationship (parent-report)
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Change in coping skills
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Change in parent-child relationship
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
measure: Social validity of the intervention
timeFrame: post-test (T1, week 6; only group 1)
measure: Subjective evaluation of the intervention
timeFrame: post-test (T1, week 6; only group 1)
measure: Change in Sibling adjustment to their brother or sister's disability
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Other outcomes:
measure: Change in Parenting self-efficacy as assessed by a 3-item version of the Parenting Sense of Competence Scale (PSOC)
timeFrame: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Amsterdam
state: Noord-Holland
Study officials:
affiliation: VU University of Amsterdam
name: Paula S Sterkenburg, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: