Improving Care and Preventing Maltreatment of Orphans

May 7, 2020 updated by: Prof. Dr. Thomas Elbert, University of Konstanz

Improving Care and Preventing Maltreatment of Orphans: A Cluster-randomized Controlled Study With Caregivers

Sub-Saharan Africa, with more than 56 million orphans worldwide, is the most affected region in terms of orphans to be cared for (UNICEF, 2014). The recently developed preventative approach Interaction Competencies with Children - for Caregivers (ICC-C; Hecker, Mkinga, Ssenyonga, & Hermenau, 2017) trains the essential interaction skills in working with children. The focus here is on strengthening a warm, sensitive and reliable relationship between caregiver and child as well as on non-violent education strategies. In a first pilot study the feasibility of the approach icould be demonstrated (Hermenau, Kaltenbach, Mkinga, & Hecker, 2015).

The study applies a two-arm cluster-randomized controlled design. The participating institutions will be randomly divided into intervention and control bodies. The follow-up examination should take place three months after the intervention. All caregivers in facility (N = approx. 150) and 25 randomly selected children (age: 6-12) per facility (N = 200) will be included in this study.

Study Overview

Detailed Description

Sub-Saharan Africa, with more than 56 million orphans worldwide, is the most affected region in terms of orphans to be cared for (UNICEF, 2014). The few studies investigating children in African orphanages mostly showed inadequate care (Espié et al., 2011; Hermenau et al., 2011; Levin & Haines, 2007; Wolff & Fesseha, 1998, 1999). In addition to the lack of trained and competent caregivers, children are also confronted with violence and abuse in the orphanages themselves (Hermenau et al., 2011; SOS Children's Villages International & University of Bedfordshire, 2014). Abuse and neglect in orphanages, in addition to traumatisation, abuse and neglect in the families of origin, pose a considerable risk for the healthy development and mental health of children (Hermenau, Goessmann, Rygaard, Landolt, & Hecker, 2017). In addition to meeting basic needs (e. g. eating, drinking, basic medical care, etc.), sensitive and non-violent education in orphanages is crucial for the emotional and physical development of children. However, the focus of previous intervention studies has been on promoting a sensitive and reliable relationship between caregiver and child. Violence and maltreatment, on the other hand, received little attention (Hermenau et al., 2017).

The recently developed preventative approach Interaction Competencies with Children - for Caregivers (ICC-C; Hecker, Mkinga, Ssenyonga, & Hermenau, 2017) trains the essential interaction skills in working with children. The focus here is on strengthening a warm, sensitive and reliable relationship between caregiver and child as well as on non-violent education strategies. In a first pilot study the feasibility of the approach could be demonstrated (Hermenau, Kaltenbach, Mkinga, & Hecker, 2015).

The study applies a two-arm cluster-randomized controlled design and includes 20 to 25 orphanages. After an initial investigation, the participating institutions will be randomly divided into intervention and control bodies. The follow-up examination should take place three months after the intervention. In addition, feasibility data will be assessed in the intervention facilities only at the beginning and the end of the intervention. All caregivers in facility (N = approx. 150) and 10-15 randomly selected children (age: 6-12) per facility (N = 300) will be included in this study. Data of caregivers will be assessed with the help of self-administered questionnaires, whereas data of children will be assessed with structured interviews.

There is a clear and pressing humanitarian need for science to address the issue of care quality and maltreatment prevention in institutional care settings in a practical manner. Perhaps surprisingly in view of this, so far no evidenced-based prevention measures adapted for the limited resources in low-income countries have been developed and scientifically evaluated. This research project can address this need, with a scientifically rigorous evaluation of a violence and maltreatment prevention program that fosters the active involvement of local personnel and that considers the limited resources of school settings in low-income countries. Through these efforts this study may help more orphans to grow-up in a supportive atmosphere, maintaining their psychological well-being and improving their performance. This preventative program aims to make a significant impact on the psychological well-being of orphans in Tanzania.

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dar Es Salaam, Tanzania
        • Dar es Salaam University College of Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for caregivers:

  • Legal age
  • Written informed consent

Inclusion Criteria for children:

  • Between 6 and 12 years
  • Written informed consent by head of institutional care facility & children oral assent

Exclusion Criteria for caregivers:

  • Acute drug or alcohol intoxication
  • Known psychiatric disorder

Exclusion Criteria for children:

- Known psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICC-C
Intervention: Interaction Competencies with children - for Caregivers (ICC-C) 11 days with 8 hours of training for caregivers. Core training components include caregiver-child interactions, maltreatment prevention, effective discipline strategies, child-centered institutional care, identifying and supporting burdened children and implementation of the training materials into the daily working

Interaction Competencies with Children - for Caregiver (ICC-C) aims to reduce maltreatment and to improve care quality in institutional care facilities. Following the idea of a train-the-trainer approach, ICC-C is designed to be delivered by trained local facilitators. ICC-C is based on attachment, behavioral and social learning theories.

The key principles are its feasibility in low-resource contexts, participatory approach, and practical orientation. ICC-C includes sessions on (a) caregiver-child interaction, (b) maltreatment prevention, (c) effective non-violent caregiving strategies, and (d) identifying and supporting burdened children.

No Intervention: Control institutions
The control institutions do not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregivers' application of harsh discipline
Time Frame: The CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
The Conflict Tactics Scale Parent-Child version (CTSPC) will assess caregiver's use of violent discipline measure against children in the child care institution. All items are rated on a 7-point Likert scale from never (0) to more than 20 times (25). The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 325 with higher scores indicating more violence) and emotional violence (5 items, potential range: 0-125, with higher scores indicating more violence).
The CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Change in children's exposure to harsh discipline by caregivers
Time Frame: CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
The Conflict Tactics Scale Parent-Child version (CTSPC) will assess the children's self-reported experiences of violent discipline in the child care institution. The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 325 with higher scores indicating more violence) and emotional violence (5 items, potential range: 0-125, with higher scores indicating more violence).
CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in student's mental health
Time Frame: SDQ will be used at (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Strength and Difficulties Questionnaire (SDQ) will assess children's internalizing and externalizing problems. The SDQ consists of five subscales of five items each, which are answered in three categories from "not true" (0), "somehow true" (1) to "certainly true" (2). The sum of all items except the ones from the prosocial behavior subscale represents atotal difficulty score (SDQ score; range 0-40, with a higher score indicating more problems). Values of 17 or higher on the SDQ score indicate severely elevated levels of mental health problems.
SDQ will be used at (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Change in caregiver's attitudes towards harsh discipline
Time Frame: The adapted version of CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Items of the Conflict Tactics Scale Parent-Child version (CTSPC) have been adapted to measure caregivers' and students' attitudes towards violent discipline methods in the child care institution. All items are rated on a 4-point Likert scale from never ok (0) to almost always ok (3). The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 39 with higher scores indicating more positive attitutudes towards violence) and emotional violence (5 items, potential range: 0-15, with higher scores indicating more positive attitudes towards violence).
The adapted version of CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ICC-C-2018-Tanzania

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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