Clinical trial NCT03594617: Improving Care and Preventing Maltreatment of Orphans
Official title: Improving Care and Preventing Maltreatment of Orphans: A Cluster-randomized Controlled Study With Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maltreatment, Child
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Bielefeld University
name: Dar es Salaam University College of Education
First posted: 2018-07-20
Enrollment: 374
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in caregivers' application of harsh discipline
timeFrame: The CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
measure: Change in children's exposure to harsh discipline by caregivers
timeFrame: CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Secondary outcomes:
measure: Change in student's mental health
timeFrame: SDQ will be used at (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
measure: Change in caregiver's attitudes towards harsh discipline
timeFrame: The adapted version of CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Dar es Salaam University College of Education
Study officials:
affiliation: Bielefeld University
name: Tobias Hecker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hecker T, Mkinga G, Kirika A, Nkuba M, Preston J, Hermenau K. Preventing maltreatment in institutional care: A cluster-randomized controlled trial in East Africa. Prev Med Rep. 2021 Oct 9;24:101593. doi: 10.1016/j.pmedr.2021.101593. eCollection 2021 Dec.