|- candidate number||19393|
|- NTR Number||NTR4768|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2014|
|- Secondary IDs||ZonMW 94309005|
|- Public Title||Effect of Mentor Support for improvement of social participation of adolescents with visual impairments|
|- Scientific Title||Effectiveness of Mentor Support for the improvement of social participation of adolescents with visual impairments: a Dutch randomized controlled trial |
|- ACRONYM||Effect of Mentor Support for improvement of social participation of adolescents with visual impairments|
|- hypothesis||The goal of this intervention is: |
1. To improve the support for successful social participation for adolescents with a visual impairment
2. To develop Mentor Support for the improvement of social participation in adolescents with visual impairments.
3. To evaluate the effect of Mentor Support for the improvement of social participation in adolescents with visual impairments
4. To evaluate the effect of Mentor Support versus care-as-usual
5. To evaluate the effect of Mentor Support executed by a mentor with a visual impairment or executed by a mentor without visual impairment
It is hypothesized that adolescents who will participate in Mentor Support will improve their social participation in comparison with adolescents who only receive care-as-usual. It is hypothesized that there will be a difference between adolescents who receive Mentor Support from a mentor with a visual impairment or from a mentor without a visual impairment.
|- Healt Condition(s) or Problem(s) studied||Visual impairment, Social functioning|
|- Inclusion criteria||- Diagnosed with visual impairment |
– Age between 16 and 22 years
– Living in the Netherlands
|- Exclusion criteria||- No additional impairments, such as hearing or intellectual impairments |
- Not speaking and understanding the Dutch language
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-okt-2017|
|- Target number of participants||120|
|- Interventions||Mentor Support is an intervention developed for adolescents with problems with social participation. These adolescents have a visual impairment but no additional impairments, such as a hearing or intellectual impairments. Mentor Support consists twelve face-to-face meetings of the adolescent with a mentor. These joint meetings take place in their own home environment with an overall duration of 12 months. On a weekly basis the adolescent and the mentor have contact via email, internet or telephone. Most of the participants will be recruited from the database of (former) clients of Stichting Bartiméus and Koninklijke Visio. These two organizations are national centers supporting visually impaired persons.|
The purpose of Mentor Support is to improve the support for successful social participation for adolescents with a visual impairment. Social participation contains three domains (education/employment, leisure activities and social relations on which the adolescents base their main goals for improvement. During the first meeting the mentor and the adolescent define these goals, also based on the ambitions of the adolescent. The monthly meetings are actions or reflective conversations derived from these goals. Through modeling, the adolescents gather information, possible actions and strategies from the mentors. Positive thinking and realizing (impossible) actions are the main focus of these meetings. For example they can visit an unknown sports club, gallery or restaurant. Also inviting and meeting (new) friends are examples of actions during Mentor Support. The adolescents will keep a record of their experiences including reflection of their thoughts and feelings. These meetings are guided by a specially designed systematic handbook with information about Mentor Support, forms and reflection assignments. The website www.mentorsupport.nl will be used to coordinate and reach all adolescents and mentors.
Mentors who voluntary participate at Mentor Support will be trained before starting with the intervention. Therefore they are not the same as professionals working at the national centers for people with visual impairments but will be role models or helping hands. The mentors will be recruited based on a database from a Dutch longitudinal study of pathways towards social participation. Mentors without visual impairments are extensively selected and trained students of HBO or university education centers. During Mentor Support all mentors are guiding two adolescents in two separate duos and receive guidance from the VU University by specially designed classes.
To test the effectiveness of Mentor Support a randomized clinical trial design will be used with pre- and posttest and follow-up. These three repeated measured will take place: before the start of Mentor Support, just after completing Mentor Support and 6 months after Mentor Support. The adolescent will randomized in three conditions: 1. Care as usual 2. Care as usual + Mentor Support by experience expert with visual impairments 3. Care as usual + Mentor Support by young adults without visual impairments. All three conditions will receive the three measurements. Stratified randomization will be used in a way that all adolescents and mentors are firstly divided into regions of the country and after this randomized into the three conditions.
|- Primary outcome||Primary outcome measures are the effectiveness of Mentor Support and the improvement of social participation in adolescents with visual impairments. |
|- Secondary outcome||Secondary outcome measures are to map the indicators of psychosocial factors of adolescents with visual impairment, to investigate the pathways and milestones to (successful) social participation and to evaluate the experiences of adolescents with visual impairments during Mentor Support. |
|- Timepoints||Repeated measurements will take place: |
1. Pretest (T1): directly before the intervention starts
2. Posttest (T2): directly after the intervention stops
3. Follow-up (T3): six months after the intervention stops
In the Computer Assisted Telephone Interviews (CATI) several structured questionnaires and open-ended questions on the domain education/employment, leisure activities and social relations are used. Furthermore, the concepts for the secondary outcomes are included also. Finally, demographic characteristics and information regarding the visual impairment are part of the interview.
Examples of structured questionnaires:
1. Acceptance of impairment: Nottingham Adjustment Scale
2. Well-Being: Dutch translation of Cantrill
3. Self-esteem: Dutch version of Rosenberg Self-Esteem Scale
4. Social competence: Dutch version of Harter’s Self Perception Profile
5. Autonomy: Noom
6. Personality: Big 5 questionnaire
7. Degree of peer activity: Dutch translation of the Degree of Peer Activity
8. Social support: Dutch Personal Network List
9. Social Network: The Social Network Map
10. Loneliness: Loneliness questionnaire of De Jong-Gierveld
11. Stigmatization questionnaire
12. Basic Psychological Need Satisfaction and frustration Scale (BPNSF)
|- Trial web site||www.mentorsupport.nl|
|- CONTACT FOR PUBLIC QUERIES||Msc. E.C.M. Heppe|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Kef|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Bartiméus Stichting, Stichting InZicht|
|- Brief summary||Social participation is challenging for adolescents and young adults with visual impairments. As a result, on average social networks are smaller, romantic relationships formed later, educational achievements lower, and career prospects limited. The support of young adolescents on their way towards that goal may benefit from the knowledge and experience of adults that have overcome similar difficulties. Therefore, a mentoring intervention will be implemented in which adolescent youth with visual impairments are matched with successfully participating young adults with visual impairments. Scientific knowledge of national longitudinal series of measurements into different domains of social participation will be used to develop and test Mentor Support. The effect of this intervention will be tested in a randomized clinical trial with at least 120 adolescents, with pretest, posttest, and follow-up. Three conditions are included to test the working ingredients: |
1) care as usual
2) care as usual + Mentor Support by experience experts with visual impairments
3) care as usual + Mentor Support by young adults without visual impairments.
Stratified randomization will be used in a way that possible mentees and mentors are firstly divided into regions of the country. The mentors will be recruited based on a database from a Dutch longitudinal study of pathways towards social participation. Mentors without visual impairments are extensively selected and trained students of HBO or university education centers. The benefits of this project include increased client participation, insights in the nodes that determine the course of social participation, and the implementation of an intervention that may increase the effects of support to adolescents with visual impairments.
|- Main changes (audit trail)|
|- RECORD||4-sep-2014 - 27-sep-2014|