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Improving Care and Preventing Maltreatment of Orphans

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ClinicalTrials.gov Identifier: NCT03594617
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
University of Bielefeld
Dar es Salaam University College of Education
Information provided by (Responsible Party):
Prof. Dr. Thomas Elbert, University of Konstanz

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Maltreatment, Child Behavioral: Interaction Competencies with Children - for Caregiver Not Applicable

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 eight to ten 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 25 randomly selected children (age: 6-12) per facility (N = 200) 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  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Care and Preventing Maltreatment of Orphans: A Cluster-randomized Controlled Study With Caregivers
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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
Behavioral: Interaction Competencies with Children - for Caregiver

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.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594617


Contacts
Contact: Tobias Hecker, PhD +49 521 106-4491 tobias.hecker@uni-bielefeld.de

Locations
Tanzania
Dar es Salaam University College of Education Recruiting
Dar Es Salaam, Tanzania
Contact: Mabuka Nkuba, PhD    +255677944885    mabula.nkuba@duce.ac.tz   
Sponsors and Collaborators
University of Konstanz
University of Bielefeld
Dar es Salaam University College of Education
Investigators
Principal Investigator: Tobias Hecker, PhD Bielefeld University

Responsible Party: Prof. Dr. Thomas Elbert, Full Professor of Clinical Psychology and Behvavioral Neuroscience, University of Konstanz
ClinicalTrials.gov Identifier: NCT03594617     History of Changes
Other Study ID Numbers: ICC-C-2018-Tanzania
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No