Improving Care and Preventing Maltreatment of Orphans

Maltreatment, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594617
• Other study ID #: ICC-C-2018-Tanzania
• Status: Completed
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2019
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: April 30, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Maltreatment, Child

Intervention

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.

Locations

Country	Name	City	State
Tanzania	Dar es Salaam University College of Education	Dar Es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
University of Konstanz	Bielefeld University, Dar es Salaam University College of Education

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in caregivers' application of harsh discipline	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)
Primary	Change in children's exposure to harsh discipline by caregivers	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	Change in student's mental health	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)
Secondary	Change in caregiver's attitudes towards harsh discipline	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)