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

NCT05235659 | Unknown DMC

• 2 other identifiers: UBremenFKZ 01KR1806D
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 2

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.

Conditions

Victimisation

Keywords

multiphase optimization strategy; foster children; parenting; revictimization; online-intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  Pre and 3 months post intervention; approx. 24 weeks after baseline

Secondary Outcomes (4)

• Change in frequency of relationship-related risk-taking behavior

  Pre and 1 week post intervention; approx. 12 weeks after baseline

• Change in level of functional behavior in relationship with caregiver

  Pre and 1 week post intervention; approx. 12 weeks after baseline

• Change in level of functional behavior in relationship with siblings

  Pre and 1 week post intervention; approx. 12 weeks after baseline

• Change in level of functional behavior across unspecified relationships

  Pre and 1 week post intervention; approx. 12 weeks after baseline

Study Arms (16)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Interventions

Basic modules BEHAVIORAL

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.

Condition 1

Basic modules and experimental condition "My coach" BEHAVIORAL

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.

Condition 2

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

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.

Condition 3

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

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.

Condition 4

Basic modules and experimental module "You are safe here" BEHAVIORAL

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.

Condition 5

Basic modules and experimental modules "You are safe here" and "My coach" BEHAVIORAL

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.

Condition 6

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

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.

Condition 7

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

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.

Condition 8

Basic modules and experimental module "Watch out!" BEHAVIORAL

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.

Condition 9

Basic modules and experimental modules "Watch out!" and "My coach" BEHAVIORAL

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.

Condition 10

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

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.

Condition 11

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

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.

Condition 12

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

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.

Condition 13

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

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.

Condition 14

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

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.

Condition 15

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

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.

Condition 16

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bremen: lead
• RWTH Aachen University: collaborator
• Bielefeld University: collaborator
• Medical School Berlin: collaborator
• Karlsruhe Institute of Technology: collaborator

Study Sites (2)

Bielefeld University

Bielefeld, 33615, Germany

RECRUITING

University of Bremen

Bremen, 28359, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 36279162 DERIVED

Related Links

• Study website (for subproject 4)

Study Officials

• Nina Heinrichs, Prof. Dr.

  University of Bremen

  PRINCIPAL INVESTIGATOR

• Kerstin Konrad, Prof. Dr.

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

• Arnold Lohaus, Prof. Dr.

  Bielefeld University

  PRINCIPAL INVESTIGATOR

• Birgit Wagner, Prof. Dr.

  Medical School Berlin

  PRINCIPAL INVESTIGATOR

• Ulrich Eber-Priemer, Prof. Dr.

  Karlsruhe Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Brühl, M.Sc.

CONTACT

+49 421 218 68542; bruehl@uni-bremen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study staff at University of Bremen will not view the allocation sequence. The database will not reveal participants' treatment condition to study staff until after the family´s eligibility was verified (after pre-assessment). Families will be informed of their allocation status after baseline data collection is completed to assure that participants are blind to allocation during the initial assessment.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 x 2 x 2 x 2 full factorial design

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 11, 2022
• Study Start: March 3, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be shared after data analysis and dissemination of main findings. Study Protocol will be shared once it is published (preferably open access). The clinical trial registry is mirroring the study protocol and includes excerpts of the submitted manuscript.
• Access Criteria: The anonymized data set will be shared with other research teams upon request.

Locations

DE (2)