Clinical trial NCT05235659: EMPOWERYOU: Examining an Internet-based Prevention Program for Primary Caregivers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Victimisation
Keywords: multiphase optimization strategy
foster children
parenting
revictimization
online-intervention
Lead sponsor: University of Bremen
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
name: Bielefeld University
name: Medical School Berlin
name: Karlsruhe Institute of Technology
First posted: 2022-02-11
Enrollment: 317
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 x 2 x 2 full factorial design
Primary purpose: PREVENTION

Brief 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. 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):

1. Component: "Watch out!" (on/off): Improving relationship-related risk detection and self-protective behavior
2. Component: "You are safe here" (on/off): Improving relationship-related safety and facilitating solid relationships
3. Component: "Who am I and where do I belong?" (on/off): Supporting the child constructing an identity
4. 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:

1. 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)
2. 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:

1. To test enduring effects of selected components on secondary outcomes at 3-month follow-up
2. To test mediating effects of theory-driven factors on the relationship between selected components on secondary outcomes
3. To explore whether there are any interaction effects between components on primary or secondary outcomes
4. 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility criteria: Inclusion Criteria:

- primary caregivers (foster or adoptive) of children aged 8 to 13 years old

Exclusion Criteria:

* acute child endangerment
* short-term foster families ("Bereitschaftspflege")
* family care ("Verwandschaftspflege")
* insufficient German language knowledge

Primary outcomes:
measure: Change in frequency of (re-)victimization
timeFrame: Pre and 3 months post intervention; approx. 24 weeks after baseline
Secondary outcomes:
measure: Change in frequency of relationship-related risk-taking behavior
timeFrame: Pre and 1 week post intervention; approx. 12 weeks after baseline
measure: Change in level of functional behavior in relationship with caregiver
timeFrame: Pre and 1 week post intervention; approx. 12 weeks after baseline
measure: Change in level of functional behavior in relationship with siblings
timeFrame: Pre and 1 week post intervention; approx. 12 weeks after baseline
measure: Change in level of functional behavior across unspecified relationships
timeFrame: Pre and 1 week post intervention; approx. 12 weeks after baseline
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Bielefeld University
city: Bremen
country: Germany
facility: University of Bremen
Study officials:
affiliation: University of Bremen
name: Nina Heinrichs, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University
name: Kerstin Konrad, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bielefeld University
name: Arnold Lohaus, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical School Berlin
name: Birgit Wagner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karlsruhe Institute of Technology
name: Ulrich Eber-Priemer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.