“Young people, adult worries”: RCT of an internet-based self-support method “Feel the ViBe” for children, adolescents and young adults exposed to family violence.|
|- candidate number||13729|
|- NTR Number||NTR3692|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-nov-2012|
|- Secondary IDs||2011/053 CMO Radboud University Nijmegen Medical Centre|
|- Public Title||“Young people, adult worries”: RCT of an internet-based self-support method “Feel the ViBe” for children, adolescents and young adults exposed to family violence.|
|- Scientific Title||“Young people, adult worries”: RCT of an internet-based self-support method “Feel the ViBe” for children, adolescents and young adults exposed to family violence.|
|- ACRONYM||Feel the ViBe|
|- hypothesis||Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek for help, do not know where to go, or perceive the threshold as too high. Almost all children of the current generation have access to the internet, which makes an online intervention easy available for this target group. In 2011, an internet-based self-support method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: “Feel the ViBe”. The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT which will be held to study the effectiveness of this intervention.|
|- Healt Condition(s) or Problem(s) studied||Domestic Violence, Mental health, Adolescents, Children, Witness violence, Sexual and reproductive health|
|- Inclusion criteria||Participants are adolescents in the age of twelve to twenty-five years old, exposed to family violence at home. Any adolescent encountering family violence at home, whether this is direct or indirect, is considered to be exposed to family violence. Inquiring participants about the type and severity of the violence as part of the inclusion procedure would enlarge the threshold for participation. We therefore choose to consider every participant eligible as target group. |
|- Exclusion criteria||Since the internet-based self-support method is in Dutch, participants who do not speak the Dutch language are excluded. If, during the intervention period, a participant proves to be not a member of the target group, he/she is asked about the reason for his/her participation. The community manager will discuss this reasons anonymously with the supervising research team and decides if the participant is permitted to continue or will be excluded from further participation. In either case, his/her data are not being used in the evaluation. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-sep-2013|
|- Target number of participants||100|
|- Interventions||“Feel the ViBe” is an internet-based intervention without face-to-face elements. “Feel the ViBe” is based on the theory that self-help, by means of peer-support and information, is an effective way of healthcare for the majority of the target group, while a minority will need further, face-to-face, help. The intervention is available online via http://www.feel-the-vibe.nl and consists of several elements, being amongst others a forum, a chat function, information, and a “ask the expert” function. More information can be obtained by contacting the corresponding author. During the RCT the intervention will be ‘frozen’: no changes will be made to the intervention, except for changes due to unexpected events, such as bug fixes. These and other unexpected events, such as system downtimes, will be registered.
“Feel the ViBe” is to be used ad libitum. However, to stimulate participation, participants receive a fact or figure by email or text message every day. Elements, such as the guided chat and “facts and figures”, are repeated every twelve weeks. Strictly spoken there is no hard endpoint to the intervention, because “Feel the ViBe” is meant to support participants as long as they need this. However, we decided to link measurements to this twelve week period. Some items are obligatory to fill out to gain access to other features, such as the questionnaires. “Feel the ViBe” is monitored by a community manager who answers questions, guides the chat, moderates the forum and addresses possible safety issues with participants. To prevent bias, the Community Manager uses a protocol. Every action from the community manager not covered by the protocol will be registered, discussed with the supervising research team, and , if necessary, added to the protocol.
The intervention group will get immediate access to “Feel the ViBe” after registration. Considering ethical concerns of withholding an intervention with a possible positive effect on physical and mental health, the control group will be a waiting list condition receiving Minimally Enhanced Usual Care (mEUC) for twelve weeks before getting access to the intervention. mEUC is in general defined as nonstudy care enhanced in minor ways to address methodological or ethical issues. For this RCT mEUC is defined as Usual Care and access to a restricted version of “Feel the ViBe” offering only access to the user profile, consent forms, digital testament, research information, questionnaires and the “ask the expert” function to ask questions in case of emergency. |
|- Primary outcome||1. The Impact of Event Scale (IES) will be used to measure PTSD symptoms. The IES is a short set of 15 questions measuring the impact of events and the amount of distress associated with events. It comprises the subscales Intrusion (8 items, mean á=0.86) and Avoidance (7 items, mean á=0.82). The IES is measured at t=0, t=1, t=2, t=3 and t=4 for both groups;|
2. The Depression and Anxiety subscales of the Symptom CheckList-90-R (SCL-90-R DEP and ANX) will be used to measure an improvement in symptoms of depression and anxiety. The SCL-90-R DEP and ANX subscales measure symptoms of depression and anxiety during the previous week on a five-point Likert scale. Both subscales showed good convergent and divergent validity, and high internal consistencies. The SCL-90-R is validated for participants of twelve years old and older. The depression subscale comprises 16 items (á=.90), the anxiety subscale comprises 10 items (á=.88). The SCL-90-R DEP and ANX subscales are measured at t=0, t=1, t=2, t=3 and t=4 for both groups.
|- Secondary outcome||1. Routine Outcome Measurement (ROM) will be used to follow participants during a session. On every login, participants will see a pop-up asking them how they would grade their mood at that precise moment on a visual analogue scale using smiley’s. After logging out they will receive a pop-up asking the same question. The scores and differences in scores before and after the session are analyzed to find any direct effects of visiting the website;|
2. An adapted version of the “Seks onder je 25e” (Sex-under-25) questionnaire will be used to measure an increase in knowledge on sexual and reproductive health, including relational health and a decrease of sexual risk taking behaviour. This questionnaire is held in the Netherlands every few years amongst children, adolescents and young adults age twelve to twenty-five. In 2011 the questionnaire was filled out online by a representative sample of 10.000 youngsters. It discusses sexual, reproductive and relational health in a broad way handling for example topics as sexual education, ‘the first time’, negative experiences, and contraception. Using this questionnaire will enable us to compare health status of the target group with a population sample. The “Seks onder je 25e” (Sex-under-25) questionnaire is measured at t=0, t=2 and t=4 for both groups;
3. The web evaluation questionnaire (WEQ) will contain questions about content, layout, the perceived effectiveness and usefulness of the website, as well as the question to give the website a motivated overall score from 0 to 10, based on their experiences and taking into account their own wishes and needs. The evaluation questionnaire has as goal to identify issues for further improvement of “Feel the ViBe”, to collect possible facilitators and barriers for implementation and to evaluate if the website meets the expectations of the target group. The WEQ is measured twelve weeks after getting access to Feel the ViBe, being t=2 for the intervention group and t=4 for the control group;
4. “Use” is measured by the collection of quantitative data - being login count and duration, visited pages, and visitor numbers - and qualitative data - being forum entries and questions asked to the experts – and is monitored on a continuous base;
5. Demographic variables and data on other (health)care and support received will be collected. At t=0, participants will also be asked to their expectations, needs and wishes for “Feel the ViBe”;
6. After participants have finished all components of the intervention, including all questionnaires, they will be asked if they consent to take part in an interview to discuss in dept their experiences with the intervention.
|- Timepoints||t=0, 0 weeks;|
t=1, 6 weeks;
t=2, 12 weeks;
t=3, 18 weeks;
t=4, 24 weeks.
|- Trial web site||www.feel-the-vibe.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Karin Rosmalen-Nooijens, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.L.M. Lagro-Janssen|
|- Sponsor/Initiator ||Radboud University Medical Centre Nijmegen|
(Source(s) of Monetary or Material Support)
|Fonds Slachtofferhulp Nederland (Victim Support Fund, the Netherlands)|
|- Brief summary||Background:|
Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek for help, do not know where to go, or perceive the threshold as too high. Almost all children of the current generation have access to the internet, which makes an online intervention easy available for this target group. In 2011, an internet-based self-support method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: “Feel the ViBe”. The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT which will be held to study the effectiveness of this intervention.
This study is a randomized controlled trial using the method of minimization to randomize the participants in two parallel groups with a 1:1 allocation ratio, being an intervention group, having access to “Feel the ViBe”+ usual care (UC), and a control group, having access to minimally enhanced usual care (mEUC) followed by access to the intervention after twelve weeks. Outcomes are measured with questionnaires on PTSD symptoms, mental health, and sexual and reproductive health. Routine Outcome Measurement will be used to measure a direct effect of participating in the intervention. Data from a web evaluation questionnaire (WEQ), user statistics and qualitative analysis of online data will be used to support the findings. To compare results Cohen’s d effect sizes will be used.
E-health applications for mental health problems have not always been properly investigated. A RCT and process evaluation will test effectiveness and help us understand how the effects can be explained, how the intervention meets the expectation of participants and what possible barriers and facilitators for implementation are. Qualitative analysis will complete this study. This makes “Feel the ViBe” unique in its field.
|- Main changes (audit trail)|
|- RECORD||8-nov-2012 - 19-nov-2012|
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