|- candidate number||28314|
|- NTR Number||NTR6944|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2017|
|- Secondary IDs||VCWE-2017-004 Vaste Commissie Wetenschap en Ethiek VU|
|- Public Title||Improving empathy and self-efficacy in caregivers of persons with intellectual disabilities, using m-learning (HiSense APP-ID)|
|- Scientific Title||Improving empathy and self-efficacy in caregivers of persons with intellectual disabilities, using m-learning (HiSense APP-ID)|
|- hypothesis||Persons with intellectual disabilities remain dependent on a caregiver for various aspects of their life, often including coping with emotions and stress. It is therefore crucial that parents and other caregivers of persons with ID are aware of their responsibilities in establishing a secure relationship and that they know how to support the emotional development of their child or client.
The HiSense APP-ID was hypothesized to have positive effe|
cts on the basic knowledge about attachment theory, and to increase empathy and self-efficacy in parents/relatives and professional caregivers of persons with mild or moderate ID.
- Parents/relatives and professional caregivers will experience the intervention as a pleasant and challenging way to gain theoretical knowledge.
- Participation in the intervention will be associated with an increase in theoretical knowledge about sensitive and responsive interaction, both for parents/relatives and professional caregivers.
- Participation in the intervention will be associated with an increase in empathy and self-reported competence, both for parents/relatives and professional caregivers.
|- Healt Condition(s) or Problem(s) studied||Intellectual disabillities, Empathy, Confidence, Attachment|
|- Inclusion criteria||The participants will be 116 parents/relatives of individuals with mild or moderate ID and 116 professional caregivers of persons with mild or moderate ID.
Close relatives, such as a brother or sister, uncle or aunt, can participate if the parents of a client are no longer the primary caregiver in the family.
Participants are invited to participate when they care for one or more persons with mild or moderate ID.
|- Exclusion criteria||-If persons care for persons with severe or multiple disabilities, or |
- when their use of the APP will be interrupted for more than five consecutive days.
- For parents/relatives, only one family member per client is included.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||31-mei-2018|
|- Target number of participants||252|
|- Interventions||The effect of the HiSense APP-ID will be assessed in two separate two-group, parallel, single blinded randomized control trials. Parents and close family members are treated as one group, and professional caregivers as another group, are treated as separate groups in the analysis. |
Within each group a randomized controlled trial is conducted.
The HiSense APP- ID uses questions, statements and practical examples to inform parents/relatives and professional caregivers about the influence of their sensitivity and reactivity in the context of attachment and communication. The m-learning intervention is divided into short, daily sessions. Each day participants complete four multiple-choice questions. They receive feedback on their original answer (correct or wrong) and an additional explanation is given for the correct answer. The topics are revisited repeatedly over time in different questions.
The main topics in the intervention are 1) attachment theory in daily practice, 2) socio-emotional functioning in persons with ID, 3) sensitivity and responsiveness to communicative signals, 4) emotion regulation, 5) observation and interpretation of behavior, and 6) basic knowledge about ID and common comorbidities such as Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder. Each topic is addressed in 15 questions, except 1) attachment theory which has 45 questions. Phrasing is differentiated for parents/relatives and professional caregivers, corresponding to their relationship to individuals with ID.
|- Primary outcome||Knowledgde test about attachment relationships|
EmpathieQuotiënt and Interpersonal Reactivity Index
Self-Efficacy in the Nurturing Role scale
|- Secondary outcome||Social Validity Scale and the influence of demographic characteristics of participants|
|- Timepoints||T0: baseline|
- Demographic variables
- Social Validity
- Knowledge test
- Social Validity
- Knowledge test
- Knowledge test
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Paula Sterkenburg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Paula Sterkenburg|
|- Sponsor/Initiator ||Amsterdam Public Health Research Institute, Bartiméus, Ons Tweede Thuis, Department of Clinical Child and Family Studies, Vrije Universiteit|
(Source(s) of Monetary or Material Support)
|The Netherlands Organisation for Health Research and Development, ZonMw (Project number 845004004).|
|- Brief summary||The present m-learning intervention aims to educate parents/relatives and caregivers, and to encourage reflection on the interaction with their child or client with an intellectual disability. Growth in theoretical and practical insight should increase the sensitivity and responsivity that are necessary to form a secure relationship with their child or client, and improve their sense of self-efficacy.
The intervention offers small quantities of theoretical and practical knowledge in an m-learning course. The course requires five minutes each day, over a period of 30 days. Each day participants will answer four multiple-choice questions, and receive feedback afterwards. The study aims to explore the effects of the HiSense APP-ID intervention on theoretical knowledge, empathy and self-efficacy of parents/relatives and professional caregivers of persons with mild or moderate intellectual disabilities.
A randomized controlled trial will be conducted among 116 parents/relatives and 116 professional caregivers with mild or moderate intellectual disability. Data will be collected on three timepoints: at the start of the intervention, at the end of the intervention, and after a 30-day retention period.
|- Main changes (audit trail)||METC goedkeuring niet nodig. |
|- RECORD||7-dec-2017 - 2-feb-2018|