EMPOWERYOU: Examining an Internet-based Prevention Program for Primary Caregivers (EMPOWERYOU-4)

University of Bremen

Status: Enrolling

Conditions: Victimisation

Treatments: Behavioral: Basic modules and experimental modules "Who am I and where do I belong?" and "My coach"; Behavioral: Basic modules and experimental modules "Watch out!", "Who am I and where do I belong?", and "My coach"; Behavioral: Basic modules and experimental modules "You are safe here", "Who am I and where do I belong?", and "My coach"; Behavioral: Basic modules and experimental module "Who am I and where do I belong?"; Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "My coach"; Behavioral: Basic modules; Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "Who am I and where do I belong?"; Behavioral: Basic modules and experimental modules "Watch out!" and "My coach"; Behavioral: Basic modules and experimental modules "Watch out!" and "Who am I and where do I belong?"; Behavioral: Basic modules and experimental condition "My coach"; Behavioral: Basic modules and experimental modules "Watch out!" and "You are safe here"; Behavioral: Basic modules and experimental module "Watch out!"; Behavioral: Basic modules and experimental modules "You are safe here" and "My coach"; Behavioral: Basic modules and experimental modules "You are safe here" and "Who am I and where do I belong?"; Behavioral: Basic modules and experimental module "You are safe here"; Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", "Who am I and where do I belong?", and "My coach"

Study type: Interventional

Funder types: Other

Identifiers

NCT05235659

UBremen

FKZ 01KR1806D (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 317 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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317 participants in 16 patient groups

Condition 1

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules

Condition 2

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental condition "My coach"

Condition 3

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental module "Who am I and where do I belong?"

Condition 4

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Who am I and where do I belong?" and "My coach"

Condition 5

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental module "You are safe here"

Condition 6

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "You are safe here" and "My coach"

Condition 7

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "You are safe here" and "Who am I and where do I belong?"

Condition 8

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "You are safe here", "Who am I and where do I belong?", and "My coach"

Condition 9

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental module "Watch out!"

Condition 10

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!" and "My coach"

Condition 11

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!" and "Who am I and where do I belong?"

Condition 12

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!", "Who am I and where do I belong?", and "My coach"

Condition 13

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!" and "You are safe here"

Condition 14

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "My coach"

Condition 15

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", and "Who am I and where do I belong?"

Condition 16

Experimental group

Description:

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

Treatment:

Behavioral: Basic modules and experimental modules "Watch out!", "You are safe here", "Who am I and where do I belong?", and "My coach"