Improving Care and Preventing Maltreatment of Orphans

NCT ID: NCT03594617

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 374 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2020-04-30

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.

Conditions

Maltreatment, Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Interaction Competencies with Children - for Caregiver

Intervention Type: BEHAVIORAL

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.

Control institutions

The control institutions do not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Legal age
• Written informed consent

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

Exclusion Criteria

• Acute drug or alcohol intoxication
• Known psychiatric disorder

• Known psychiatric disorder

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bielefeld University

OTHER

Sponsor Role: collaborator

Dar es Salaam University College of Education

UNKNOWN

Sponsor Role: collaborator

University of Konstanz

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Thomas Elbert

Full Professor of Clinical Psychology and Behvavioral Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Hecker, PhD

Role: PRINCIPAL_INVESTIGATOR

Bielefeld University

Locations

Dar es Salaam University College of Education

Dar es Salaam, , Tanzania

Countries

Tanzania

References

Hecker T, Mkinga G, Hartmann E, Nkuba M, Hermenau K. Sustainability of effects and secondary long-term outcomes: One-year follow-up of a cluster-randomized controlled trial to prevent maltreatment in institutional care. PLOS Glob Public Health. 2022 May 20;2(5):e0000286. doi: 10.1371/journal.pgph.0000286. eCollection 2022.

Reference Type: DERIVED

PMID: 36962306 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34976652 (View on PubMed)

Other Identifiers

ICC-C-2018-Tanzania

Identifier Type: -

Identifier Source: org_study_id