Maltreatment, ChildNCT03594617
Improving Care and Preventing Maltreatment of Orphans
A study testing Interaction Competencies with Children - for Caregiver in people with Maltreatment, Child, run by University of Konstanz at 1 site in Tanzania.
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… Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Maltreatment, Child
- What is being tested?
- Interaction Competencies with Children - for Caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteTanzania
- Study dates
- 14 Aug 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Legal age
- Written informed consent
- Between 6 and 12 years
- Written informed consent by head of institutional care facility \& children oral assent
Who cannot join
- Acute drug or alcohol intoxication
- Known psychiatric disorder
- Known psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Interaction Competencies with Children - for Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction Competencies with Children - for CaregiverBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ICC-C | Experimental | 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 Receives: Behavioral: Interaction Competencies with Children - for Caregiver |
| Control institutions | No intervention | The control institutions do not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Secondary outcomes (2)
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.
Measured: 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
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).
Measured: The adapted version of CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start14 Aug 2018
- Primary completion1 Jul 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maltreatment, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Bielefeld University, Dar es Salaam University College of Education
- Responsible party
- Principal investigator, Prof. Dr. Thomas Elbert, University of Konstanz
- Investigators
- Tobias Hecker, PhD, Principal investigator, Bielefeld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594617
- Sponsor's protocol ID
- ICC-C-2018-Tanzania
- Status last verified
- Sep 2019
- First submitted
- 11 Jul 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36962306Hecker 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.
PubMed 34976652
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care and Preventing Maltreatment of Orphans: A Cluster-randomized Controlled Study With Caregivers
- ClinicalTrials.gov ID
- NCT03594617
- Acronym / sponsor ID
- ICC-C-2018-Tanzania
- Conditions
- Maltreatment, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Bielefeld University, Dar es Salaam University College of Education
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICC-C | Experimental | Behavioral: Interaction Competencies with Children - for CaregiverIntervention: 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 |
| Control institutions | No intervention | –The control institutions do not receive any intervention. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Legal age
- Written informed consent
- Between 6 and 12 years
- Written informed consent by head of institutional care facility \& children oral assent
Key exclusion criteria (3 listed)
- Acute drug or alcohol intoxication
- Known psychiatric disorder
- Known psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interaction Competencies with Children - for CaregiverInteraction 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. | Behavioural | ICC-C |
Primary outcome
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).
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).
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 36962306Hecker 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.
- Derived from this study: PubMed 34976652Hecker 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Hecker, PhD principal investigator
Bielefeld University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction Competencies with Children - for Caregiver in people with Maltreatment, Child, run by University of Konstanz at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.