VictimisationEMPOWERYOU-4NCT05235659
EMPOWERYOU: Examining an Internet-based Prevention Program for Primary Caregivers
A study testing Basic modules, Basic modules and experimental condition "My coach" and Basic modules and experimental module "Who am I and where do I belong?" in people with Victimisation, run by University of Bremen at 2 sites in Germany.
Trial summary
The primary aim of this study is to examine the effects of an internet-based prevention program for primary caregivers of preadolescent Youth in Care (Y-IC) on (re-)victimization. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Victimisation
- What is being tested?
- Basic modules, Basic modules and experimental condition "My coach" and Basic modules and experimental module "Who am I and where do I belong?"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Mar 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- primary caregivers (foster or adoptive) of children aged 8 to 13 years old
Who cannot join
- acute child endangerment
- short-term foster families ("Bereitschaftspflege")
- family care ("Verwandschaftspflege")
- insufficient German language knowledge
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Bielefeld University
Bielefeld, 33615
Antonia Brühl, M.Sc., +49 521-106-87800, antonia.bruehl@uni-bielefeld.de
- Recruiting
University of Bremen
Bremen, 28359
Antonia Brühl, M.Sc., +49 421 218 68542, bruehl@uni-bremen.de
Nina Heinrichs, Prof. Dr.
About this study
Official title: Empowering Youth in Care Against (re-)Victimization (Subproject 4): A Randomized Balanced Factorial Trial Examining an Internet-based Prevention Program for Primary Caregivers
The primary aim of this study is to examine the effects of an internet-based prevention program for primary caregivers of preadolescent Youth in Care (Y-IC) on (re-)victimization. We aim to identify the most effective intervention components by using a randomized factorial design, based on the Multiphase Optimization Strategy (MOST; Collins, 2018). In a 2 x 2 x 2 x 2 factorial trial, an initial N = 317 foster caregivers with children ages 8 - 13 are randomly assigned to one of 16 conditions. The primary outcome is the rate of (re-)victimization from pre- to 3-month follow-up. Secondary outcomes include risk-taking and functional behaviors in relationships. All caregivers will receive access to all components after trial ends if there is no significant harm associated with any of the intervention component. Participants in the condition with all component levels on are expected to show the best improvement. Anticipated date for study completion is determined by the funding period. However, we plan to apply for a study extension.
Read the detailed description
Given that childhood victimization leads to an increased vulnerability for subsequent revictimization in adolescence, findings highlight a strong need for evidence-based prevention programs targeting children with a history of child maltreatment as a high-risk population of revictimization. However, evidence-based programs for foster parents that aim to prevent revictimization of the child, while addressing the needs of the caregivers are scarce. In order to develop and tailor such services to foster parents (and youth in care) with maltreatment experiences, we developed a consumer-informed conceptual model in a prior project (EMPOWERYOU SP3) that outlines the key mediators which may impact upon the risk of revictimization and how we plan to address these with different intervention components. Thus, in subproject 3 the conceptual model and the online-intervention components were developed, involving the participants themselves as well as relevant stakeholders. The usability of the online-intervention and the feasibility of the clinical trial (EMPOWERYOU SP4) was piloted in subproject 3 (March 2021 - September 2021).
In subproject 4, we will conduct a factorial study to tear apart the main effects of each intervention component on the mediator and outcome of interest, including potential interaction effects. This will help optimizing the intervention approach. The full online-intervention comprises five content modules and a coach, who is supporting the caregiver with up to four phone-calls (50 minutes each) and short message service (SMS) or e-mail reminders. Caregivers have two weeks to work through one module. Every caregiver will receive the first two basic modules on parental self-care and child´s self-worth and emotional regulation. This allows us to offer some level of support in all conditions including the condition with the lowest component level across all factors.
Based on the MOST principles, this study will use a 2 x 2 x 2 x 2 full factorial design by randomly allocating families with equal probability to one of 16 experimental conditions. However, this factorial experiment does not represent a 16-arm randomized controlled trial (RCT). The ultimate goal is to choose from a set of four intervention components with two levels each (on/off) the one(s) that best reduce and prevent (re-)victimization. The following intervention components have been selected (three content components, one engagement/adherence component):
- Component: "Watch out!" (on/off): Improving relationship-related risk detection and self-protective behavior
- Component: "You are safe here" (on/off): Improving relationship-related safety and facilitating solid relationships
- Component: "Who am I and where do I belong?" (on/off): Supporting the child constructing an identity
- Component: "My Coach" (on/off): Professional support of the caregiver in form of up to four phone calls with a coach (i.e., one call per module 1\&2 (combined), 3, 4, and 5).
The primary research objectives are:
- To examine the efficacy of selected candidate components on primary outcome, the risk of re-victimization, at follow-up (i.e., 3 months post intervention; approx. 24 weeks after baseline)
- To examine the efficacy of selected candidate components on secondary outcomes (risk-taking behavior and functional behavior in relationships with caregiver, siblings, peers, and others) at post-test (i.e., 1 week post intervention; approx. 12 weeks after baseline)
The secondary objectives are:
- To test enduring effects of selected components on secondary outcomes at 3-month follow-up
- To test mediating effects of theory-driven factors on the relationship between selected components on secondary outcomes
- To explore whether there are any interaction effects between components on primary or secondary outcomes
- To conduct exploratory analyses of potential moderators
Based on the conceptual model described above, this study will examine the following hypotheses related to the main effects of intervention components:
- Component "Watch out!" - Relationship-related risks: We hypothesize that receiving this component will result in better detection of risk signals in relationships and less risk-taking cognitions. This will lead to less relationship-related risk-taking behavior which in turn will result in reductions of re-victimization experiences and others secondary outcomes.
- Component "You are safe here" - Relationship-related safety: We hypothesize that receiving this component will result in better detection of safety signals in relationships and more emotional security. This will lead to more functional relationship behavior which in turn will result in reductions of (re-)victimization experiences and other secondary outcomes.
- Component "Who am I and where do I belong?" - Constructing identity: We hypothesize that receiving this component will increase parental support in the child´s constructing of identity. This will lead to a more positive self-appraisal and in turn to less risk-taking and more functional relationship behavior, which in turn will result in reductions of (re-)victimization experiences and other secondary outcomes.
- Component "My Coach" - Professional support: We hypothesize that professional support from a parent coach who is facilitating each component, will result in higher program adherence/engagement which will yield larger intervention effects on primary and secondary outcomes than without professional support.
- We hypothesize that there will be an interaction effect between the relationship risk and relationship safety components. When both components will be present, the effect will be larger compared to only one of them present.
- We hypothesize that there will be an interaction effect between each component and the professional support component, such that with professional support, the effects of each component will be larger than without professional support via greater adherence/engagement of the caregiver.
- Conditions
- Victimisation
- Being tested
- Basic modules, Basic modules and experimental condition "My coach", Basic modules and experimental module "Who am I and where do I belong?", Basic modules and experimental modules "Who am I and where do I belong?" and "My coach", Basic modules and experimental module "You are safe here"
- Keywords
- multiphase optimization strategy, foster children, parenting, revictimization, online-intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic modulesBehavioural
Caregivers will only have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child.
Basic modules and experimental condition "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Professional support of the caregiver will be provided. Caregivers will receive one phone call (50 minutes) to support processing of information from module 1 and 2. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental module "Who am I and where do I belong?"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers.
Basic modules and experimental modules "Who am I and where do I belong?" and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support of the caregiver will be provided. Caregivers will receive two phone calls (each 50 minutes) to support processing of information from module 1, 2, and 5. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental module "You are safe here"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers.
Basic modules and experimental modules "You are safe here" and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Professional support of the caregiver will be provided. Caregivers will receive two phone calls (each 50 minutes) to support processing of information from module 1, 2, and 4. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental modules "You are safe here" and "Who am I and where do I belong?"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers.
Basic modules and experimental modules "You are safe here", "Who am I and where do I belong?", and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support of the caregiver will be provided. Caregivers will receive three phone calls (each 50 minutes) to support processing of information from module 1, 2, 4, and 5. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental module "Watch out!"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior.
Basic modules and experimental modules "Watch out!" and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Professional support of the caregiver will be provided. Caregivers will receive two phone calls (each 50 minutes) to support processing of information from module 1, 2, and 3. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental modules "Watch out!" and "Who am I and where do I belong?"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers.
Basic modules and experimental modules "Watch out!", "Who am I and where do I belong?", and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support of the caregiver will be provided. Caregivers will receive three phone calls (each 50 minutes) to support processing of information from module 1, 2, 3, and 5. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental modules "Watch out!" and "You are safe here"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers.
Basic modules and experimental modules "Watch out!", "You are safe here", and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Professional support of the caregiver will be provided. Caregivers will receive three phone calls (each 50 minutes) to support processing of information from module 1, 2, 3, and 4. Finally, they will receive text messages or emails with the core message of the modules.
Basic modules and experimental modules "Watch out!", "You are safe here", and "Who am I and where do I belong?"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers.
Basic modules and experimental modules "Watch out!", "You are safe here", "Who am I and where do I belong?", and "My coach"Behavioural
Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation. They will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Further access will be provided to module 4 "You are safe here" on improving children´s relationship-related safety and facilitating solid relationships. Access to module 5 "Who am I and where do I belong?" will support caregivers in helping their child develop an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support will be provided. They will receive four phone calls (each 50 minutes) to support processing of information from module 1, 2, 3, 4, and 5. Text messages or emails with the core message of the modules will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off Receives: Behavioral: Basic modules |
| Condition 2 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental condition "My coach" |
| Condition 3 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental module "Who am I and where do I belong?" |
| Condition 4 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "Who am I and where do I belong?" and "My coach" |
| Condition 5 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental module "You are safe here" |
| Condition 6 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "You are safe here" and "My coach" |
| Condition 7 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental modules "You are safe here" and "Who am I and where do I belong?" |
| Condition 8 | Experimental | Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "You are safe here", "Who am I and where do I belong?", and "My coach" |
| Condition 9 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental module "Watch out!" |
| Condition 10 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "Watch out!" and "My coach" |
| Condition 11 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental modules "Watch out!" and "Who am I and where do I belong?" |
| Condition 12 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "Watch out!", "Who am I and where do I belong?", and "My coach" |
| Condition 13 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental modules "Watch out!" and "You are safe here" |
| Condition 14 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "My coach" |
| Condition 15 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off Receives: Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "Who am I and where do I belong?" |
| Condition 16 | Experimental | Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on Receives: Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", "Who am I and where do I belong?", and "My coach" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of (re-)victimization
The (re-)victimization composite score derived from two parent-report measures: The Juvenile Victimization Questionnaire (JVQ) and the Bullying screener. The JVQ is a widely used measure to assess victimization in children aged 8 to 17 years. It consists of 37 items spanning five domains: crime, child maltreatment, peer and sibling victimization, sexual victimization and witnessing crime with follow-up questions that also assess the frequency and perpetrators of the victimization events. Caregivers will be asked whether the child was exposed to the respective event during life and (if yes) during the last 3 months. Participants respond with yes (1) or no (0). The Bullying screener is a 6-item screening tool. After the respective definition of bullying type, caregivers are asked how often these things happened to the child or how often he/she has done this to others in the last 3 months. Caregivers then respond on a 4-point scale from never to a lot (at least once a week).
Measured: Pre and 3 months post intervention; approx. 24 weeks after baseline
Secondary outcomes (4)
Change in frequency of relationship-related risk-taking behavior
Relationship-related risk-taking behaviors wilt be assessed with a self-developed questionnaire on risk situations in relationships. The questionnaire comprises 14 risky situations (e.g., "How often has someone done something to your child even though he/she did not want that and said "no"?"). Caregivers and children are asked how often the risky situation occurred during the last three months (frequency).
Measured: Pre and 1 week post intervention; approx. 12 weeks after baseline
Change in level of functional behavior in relationship with caregiver
To assess functional relationship behavior in the relationship with the caregiver, the subscales communication and involvement of the Parenting Relationship Questionnaire (PRQ) will be used (22 items).
Measured: Pre and 1 week post intervention; approx. 12 weeks after baseline
Change in level of functional behavior in relationship with siblings
To assess functional relationship behavior in relationship with siblings, we will use the seven subscales referring to "warmth and closeness" of the Sibling Relationship Questionnaires (SRQ-deu; 21 items).
Measured: Pre and 1 week post intervention; approx. 12 weeks after baseline
Change in level of functional behavior across unspecified relationships
To assess functional relationship behavior across unspecified relationships, the Relationship Problems Questionnaire (RPQ) will be used (10 items).
Measured: Pre and 1 week post intervention; approx. 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start3 Mar 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VictimisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 x 2 x 2 full factorial design
- Masking
- None (open label)
- Enrolment
- 317 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bremen
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University, Bielefeld University, Medical School Berlin, Karlsruhe Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Nina Heinrichs, Prof. Dr., Principal investigator, University of BremenKerstin Konrad, Prof. Dr., Principal investigator, RWTH Aachen UniversityArnold Lohaus, Prof. Dr., Principal investigator, Bielefeld UniversityBirgit Wagner, Prof. Dr., Principal investigator, Medical School BerlinUlrich Eber-Priemer, Prof. Dr., Principal investigator, Karlsruhe Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235659
- Sponsor's protocol ID
- UBremen
- Other IDs
- FKZ 01KR1806D
- Acronym
- EMPOWERYOU-4
- Status last verified
- Dec 2023
- First submitted
- 27 Jan 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to share results with members of the scientific community. The anonymized data set will be stored for 10 years and shared with other research teams upon request, using a repository that will be chosen by the consortium (advised by the DSMB).
Publications
Heinrichs N, Bruhl A. Preventing Revictimization Through a Web-Based Intervention for Primary Caregivers of Youth in Care (EMPOWERYOU): Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2022 Oct 24;11(10):e38183. doi: 10.2196/38183.
PubMed 36279162
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Youth in Care Against (re-)Victimization (Subproject 4): A Randomized Balanced Factorial Trial Examining an Internet-based Prevention Program for Primary Caregivers
- ClinicalTrials.gov ID
- NCT05235659
- Acronym / sponsor ID
- EMPOWERYOU-4 / UBremen
- Conditions
- Victimisation
- Keywords
- multiphase optimization strategy, foster children, parenting, revictimization, online-intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- University of BremenUniversity, hospital or other
- Collaborators
- RWTH Aachen University, Bielefeld University, Medical School Berlin, Karlsruhe Institute of Technology
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to examine the effects of an internet-based prevention program for primary caregivers of preadolescent Youth in Care (Y-IC) on (re-)victimization. We aim to identify the most effective intervention components by using a randomized factorial design, based on the Multiphase Optimization Strategy (MOST; Collins, 2018). In a 2 x 2 x 2 x 2 factorial trial, an initial N = 317 foster caregivers with children ages 8 - 13 are randomly assigned to one of 16 conditions. The primary outcome is the rate of (re-)victimization from pre- to 3-month follow-up. Secondary outcomes include risk-taking and functional behaviors in relationships. All caregivers will receive access to all components after trial ends if there is no significant harm associated with any of the intervention component. Participants in the condition with all component levels on are expected to show the best improvement. Anticipated date for study completion is determined by the funding period. However, we plan to apply for a study extension.
Detailed description
Given that childhood victimization leads to an increased vulnerability for subsequent revictimization in adolescence, findings highlight a strong need for evidence-based prevention programs targeting children with a history of child maltreatment as a high-risk population of revictimization. However, evidence-based programs for foster parents that aim to prevent revictimization of the child, while addressing the needs of the caregivers are scarce. In order to develop and tailor such services to foster parents (and youth in care) with maltreatment experiences, we developed a consumer-informed conceptual model in a prior project (EMPOWERYOU SP3) that outlines the key mediators which may impact upon the risk of revictimization and how we plan to address these with different intervention components. Thus, in subproject 3 the conceptual model and the online-intervention components were developed, involving the participants themselves as well as relevant stakeholders. The usability of the online-intervention and the feasibility of the clinical trial (EMPOWERYOU SP4) was piloted in subproject 3 (March 2021 - September 2021).
In subproject 4, we will conduct a factorial study to tear apart the main effects of each intervention component on the mediator and outcome of interest, including potential interaction effects. This will help optimizing the intervention approach. The full online-intervention comprises five content modules and a coach, who is supporting the caregiver with up to four phone-calls (50 minutes each) and short message service (SMS) or e-mail reminders. Caregivers have two weeks to work through one module. Every caregiver will receive the first two basic modules on parental self-care and child´s self-worth and emotional regulation. This allows us to offer some level of support in all conditions including the condition with the lowest component level across all factors.
Based on the MOST principles, this study will use a 2 x 2 x 2 x 2 full factorial design by randomly allocating families with equal probability to one of 16 experimental conditions. However, this factorial experiment does not represent a 16-arm randomized controlled trial (RCT). The ultimate goal is to choose from a set of four intervention components with two levels each (on/off) the one(s) that best reduce and prevent (re-)victimization. The following intervention components have been selected (three content components, one engagement/adherence component):
- Component: "Watch out!" (on/off): Improving relationship-related risk detection and self-protective behavior
- Component: "You are safe here" (on/off): Improving relationship-related safety and facilitating solid relationships
- Component: "Who am I and where do I belong?" (on/off): Supporting the child constructing an identity
- Component: "My Coach" (on/off): Professional support of the caregiver in form of up to four phone calls with a coach (i.e., one call per module 1\&2 (combined), 3, 4, and 5).
The primary research objectives are:
- To examine the efficacy of selected candidate components on primary outcome, the risk of re-victimization, at follow-up (i.e., 3 months post intervention; approx. 24 weeks after baseline)
- To examine the efficacy of selected candidate components on secondary outcomes (risk-taking behavior and functional behavior in relationships with caregiver, siblings, peers, and others) at post-test (i.e., 1 week post intervention; approx. 12 weeks after baseline)
The secondary objectives are:
- To test enduring effects of selected components on secondary outcomes at 3-month follow-up
- To test mediating effects of theory-driven factors on the relationship between selected components on secondary outcomes
- To explore whether there are any interaction effects between components on primary or secondary outcomes
- To conduct exploratory analyses of potential moderators
Based on the conceptual model described above, this study will examine the following hypotheses related to the main effects of intervention components:
- Component "Watch out!" - Relationship-related risks: We hypothesize that receiving this component will result in better detection of risk signals in relationships and less risk-taking cognitions. This will lead to less relationship-related risk-taking behavior which in turn will result in reductions of re-victimization experiences and others secondary outcomes.
- Component "You are safe here" - Relationship-related safety: We hypothesize that receiving this component will result in better detection of safety signals in relationships and more emotional security. This will lead to more functional relationship behavior which in turn will result in reductions of (re-)victimization experiences and other secondary outcomes.
- Component "Who am I and where do I belong?" - Constructing identity: We hypothesize that receiving this component will increase parental support in the child´s constructing of identity. This will lead to a more positive self-appraisal and in turn to less risk-taking and more functional relationship behavior, which in turn will result in reductions of (re-)victimization experiences and other secondary outcomes.
- Component "My Coach" - Professional support: We hypothesize that professional support from a parent coach who is facilitating each component, will result in higher program adherence/engagement which will yield larger intervention effects on primary and secondary outcomes than without professional support.
- We hypothesize that there will be an interaction effect between the relationship risk and relationship safety components. When both components will be present, the effect will be larger compared to only one of them present.
- We hypothesize that there will be an interaction effect between each component and the professional support component, such that with professional support, the effects of each component will be larger than without professional support via greater adherence/engagement of the caregiver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- 2 x 2 x 2 x 2 full factorial design
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Basic modulesComponent 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off |
| Condition 2 | Experimental | Behavioral: Basic modules and experimental condition "My coach"Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on |
| Condition 3 | Experimental | Behavioral: Basic modules and experimental module "Who am I and where do I belong?"Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off |
| Condition 4 | Experimental | Behavioral: Basic modules and experimental modules "Who am I and where do I belong?" and "My coach"Component 1 (Watch out!): off, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on |
| Condition 5 | Experimental | Behavioral: Basic modules and experimental module "You are safe here"Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off |
| Condition 6 | Experimental | Behavioral: Basic modules and experimental modules "You are safe here" and "My coach"Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on |
| Condition 7 | Experimental | Behavioral: Basic modules and experimental modules "You are safe here" and "Who am I and where do I belong?"Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off |
| Condition 8 | Experimental | Behavioral: Basic modules and experimental modules "You are safe here", "Who am I and where do I belong?", and "My coach"Component 1 (Watch out!): off, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on |
| Condition 9 | Experimental | Behavioral: Basic modules and experimental module "Watch out!"Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off |
| Condition 10 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!" and "My coach"Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on |
| Condition 11 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!" and "Who am I and where do I belong?"Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off |
| Condition 12 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!", "Who am I and where do I belong?", and "My coach"Component 1 (Watch out!): on, Component 2 ("You are safe here"): off, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on |
| Condition 13 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!" and "You are safe here"Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): off |
| Condition 14 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "My coach"Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): off, Component 4 ("My coach"): on |
| Condition 15 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "Who am I and where do I belong?"Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): off |
| Condition 16 | Experimental | Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", "Who am I and where do I belong?", and "My coach"Component 1 (Watch out!): on, Component 2 ("You are safe here"): on, Component 3 ("Who am I and where do I belong?"): on, Component 4 ("My coach"): on |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- primary caregivers (foster or adoptive) of children aged 8 to 13 years old
Key exclusion criteria (4 listed)
- acute child endangerment
- short-term foster families ("Bereitschaftspflege")
- family care ("Verwandschaftspflege")
- insufficient German language knowledge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic modulesCaregivers will only have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. | Behavioural | Condition 1 |
| Basic modules and experimental condition "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Professional support of the caregiver will be provided. Caregivers will receive one phone call (50 minutes) to support processing of information from module 1 and 2. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 2 |
| Basic modules and experimental module "Who am I and where do I belong?"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. | Behavioural | Condition 3 |
| Basic modules and experimental modules "Who am I and where do I belong?" and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support of the caregiver will be provided. Caregivers will receive two phone calls (each 50 minutes) to support processing of information from module 1, 2, and 5. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 4 |
| Basic modules and experimental module "You are safe here"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. | Behavioural | Condition 5 |
| Basic modules and experimental modules "You are safe here" and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Professional support of the caregiver will be provided. Caregivers will receive two phone calls (each 50 minutes) to support processing of information from module 1, 2, and 4. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 6 |
| Basic modules and experimental modules "You are safe here" and "Who am I and where do I belong?"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. | Behavioural | Condition 7 |
| Basic modules and experimental modules "You are safe here", "Who am I and where do I belong?", and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support of the caregiver will be provided. Caregivers will receive three phone calls (each 50 minutes) to support processing of information from module 1, 2, 4, and 5. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 8 |
| Basic modules and experimental module "Watch out!"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. | Behavioural | Condition 9 |
| Basic modules and experimental modules "Watch out!" and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Professional support of the caregiver will be provided. Caregivers will receive two phone calls (each 50 minutes) to support processing of information from module 1, 2, and 3. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 10 |
| Basic modules and experimental modules "Watch out!" and "Who am I and where do I belong?"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. | Behavioural | Condition 11 |
| Basic modules and experimental modules "Watch out!", "Who am I and where do I belong?", and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support of the caregiver will be provided. Caregivers will receive three phone calls (each 50 minutes) to support processing of information from module 1, 2, 3, and 5. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 12 |
| Basic modules and experimental modules "Watch out!" and "You are safe here"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. | Behavioural | Condition 13 |
| Basic modules and experimental modules "Watch out!", "You are safe here", and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Professional support of the caregiver will be provided. Caregivers will receive three phone calls (each 50 minutes) to support processing of information from module 1, 2, 3, and 4. Finally, they will receive text messages or emails with the core message of the modules. | Behavioural | Condition 14 |
| Basic modules and experimental modules "Watch out!", "You are safe here", and "Who am I and where do I belong?"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation of caregiver and child. Caregivers will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Caregivers will have access to module 4 "You are safe here" to improve children´s relationship-related safety and facilitate solid relationships with family and peers. Caregivers will have access to the module 5 "Who am I and where do I belong?" This module will support caregivers in helping their child developing an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. | Behavioural | Condition 15 |
| Basic modules and experimental modules "Watch out!", "You are safe here", "Who am I and where do I belong?", and "My coach"Caregivers will have access to the two basic modules (1\&2) in order to increase knowledge on parental self-care and facilitating the self-worth of the child as well as emotional regulation. They will have access to module 3 "Watch out!" on improving children´s relationship-related risk detection and self-protective behavior. Further access will be provided to module 4 "You are safe here" on improving children´s relationship-related safety and facilitating solid relationships. Access to module 5 "Who am I and where do I belong?" will support caregivers in helping their child develop an identity of their choice, while providing the freedom to consider potential contributing influences of the family of origin, foster family, and peers. Professional support will be provided. They will receive four phone calls (each 50 minutes) to support processing of information from module 1, 2, 3, 4, and 5. Text messages or emails with the core message of the modules will be provided. | Behavioural | Condition 16 |
Primary outcome
Change in frequency of (re-)victimization
Time frame: Pre and 3 months post intervention; approx. 24 weeks after baseline
The (re-)victimization composite score derived from two parent-report measures: The Juvenile Victimization Questionnaire (JVQ) and the Bullying screener. The JVQ is a widely used measure to assess victimization in children aged 8 to 17 years. It consists of 37 items spanning five domains: crime, child maltreatment, peer and sibling victimization, sexual victimization and witnessing crime with follow-up questions that also assess the frequency and perpetrators of the victimization events. Caregivers will be asked whether the child was exposed to the respective event during life and (if yes) during the last 3 months. Participants respond with yes (1) or no (0). The Bullying screener is a 6-item screening tool. After the respective definition of bullying type, caregivers are asked how often these things happened to the child or how often he/she has done this to others in the last 3 months. Caregivers then respond on a 4-point scale from never to a lot (at least once a week).
4 secondary outcomes
Change in frequency of relationship-related risk-taking behavior
Time frame: Pre and 1 week post intervention; approx. 12 weeks after baseline
Change in level of functional behavior in relationship with caregiver
Time frame: Pre and 1 week post intervention; approx. 12 weeks after baseline
Change in level of functional behavior in relationship with siblings
Time frame: Pre and 1 week post intervention; approx. 12 weeks after baseline
Change in level of functional behavior across unspecified relationships
Time frame: Pre and 1 week post intervention; approx. 12 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 36279162Heinrichs N, Bruhl A. Preventing Revictimization Through a Web-Based Intervention for Primary Caregivers of Youth in Care (EMPOWERYOU): Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2022 Oct 24;11(10):e38183. doi: 10.2196/38183.
- Individual participant dataSharing planned: Yes. It is planned to share results with members of the scientific community. The anonymized data set will be stored for 10 years and shared with other research teams upon request, using a repository that will be chosen by the consortium (advised by the DSMB).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Heinrichs, Prof. Dr. principal investigator
University of Bremen
Kerstin Konrad, Prof. Dr. principal investigator
RWTH Aachen University
Arnold Lohaus, Prof. Dr. principal investigator
Bielefeld University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic modules, Basic modules and experimental condition "My coach" and Basic modules and experimental module "Who am I and where do I belong?" in people with Victimisation, run by University of Bremen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonia Brühl, M.Sc. (+49 421 218 68542, bruehl@uni-bremen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of (re-)victimization (time frame: Pre and 3 months post intervention; approx. 24 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.