No registrations found.
ID
Source
Brief title
Health condition
Intellectual disability, challenging behavior
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is challenging behavior, quality of life, emotional wellbeing and EF.
Secondary outcome
In addition to the primary outcomes, which will be assessed at three time points, the data regarding the role of musical activities in the lives of the participants will be examined. Furthermore, the self-reported feelings before and after each session will be analyzed. Evaluation forms completed by participants and their caregivers and data regarding the sustainability of taking part in musical activities after the completion of the intervention provide feedback on the effectiveness and strengths and weaknesses of the intervention. In addition, the logs that the music intervention implementers kept will be analyzed.
Background summary
This randomized controlled trial compares the effect of an individual music intervention with care as usual on emotional and behavioral problems and executive functioning among people with mild to moderate intellectual disability and challenging behavior. Furthermore, the self-reported feelings before and after each session will be analyzed. The design of this study is a RCT with two arms: a music intervention and a care as usual (CAU) group. A pre-post-follow-up design will be employed.
Study objective
The overall aim of this RCT is to examine whether an individual music intervention can improve the challenging behavior, quality of life, emotional wellbeing and EF of adults with a mild to moderate ID.
Study design
A pre-post-follow-up design will be employed.
Intervention
Participants that are included are randomized to one of two conditions: music intervention or CAU.
• Music intervention (experimental group)
This intervention consists of sixteen music session within a maximum of 10 weeks. The music sessions will be carried out by musical caregivers, which can be professional caregivers, relatives, volunteers or professional music coaches. Additionally, there will be two scheduled meetings for the musical caregivers for intervision purposes. The music intervention will be provided in accordance with a training manual for musical caregivers. This training manual is especially developed for this study, with the input of different advisory groups.
In the manual intervention procedures are specified. The setting, general goals, contents of the music sessions and basic principles of the intervention as well as exemplifications will be outlined. By use of this protocol the intervention is standardized, but the protocol leaves enough flexibility to tailor the intervention to the characteristics and needs of the participants.
• CAU (control group)
Participants randomized into the experimental condition will receive both the musical intervention and CAU, while participants who are randomly allocated to the control group will receive only CAU during the study. Care as usual might include musical activities on facility-level, as music is a central theme among facilities of Stichting Philadelphia Zorg. However, individual musical activities will be postponed. Participants in the control group will be offerend musical activities at the end of the study, if they are still interested in this.
• Extra-music intervention
Ten participants who are randomized into the experimental condition will receive a specific music intervention, where there is a maximal musical input. They will be exposed to music as often as can be. By this manner, it is possible to examine the effect of additional music.
Inclusion criteria
• Mild or moderate ID (35-70)
• Age: 18 years or older
• VG-6 indication (or problems often accompanied by a VG-6 indication)
• Mentally competent to consent to participate in this research
Exclusion criteria
• Inability to participate in an intervention for at least one hour
• Hearing impairment, which cannot be corrected with a hearing aid
• Serious medical condition which limits participation (e.g. dementia)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8482 |
| Other | non-WMO: METc VUmc : 2018.439 (A2020.028) |