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

NCT05235659 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2023-12-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

Basic modules

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • RWTH Aachen University

    collaborator OTHER
  • Bielefeld University

    collaborator OTHER
  • Medical School Berlin

    collaborator OTHER
  • Karlsruhe Institute of Technology

    collaborator OTHER
  • University of Bremen

    lead OTHER

Principal Investigators

  • Nina Heinrichs, Prof. Dr. · University of Bremen

  • Kerstin Konrad, Prof. Dr. · RWTH Aachen University

  • Arnold Lohaus, Prof. Dr. · Bielefeld University

  • Birgit Wagner, Prof. Dr. · Medical School Berlin

  • Ulrich Eber-Priemer, Prof. Dr. · Karlsruhe Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235659 on ClinicalTrials.gov