Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107499406828 Date of Approval: 14/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of Narrative Therapy Approach in Behavior Disorders Healing Process among Abandoned Children in Rwanda
Official scientific title Role of Narrative Therapy Approach in Behavior Disorders Healing Process among Abandoned Children in Rwanda
Brief summary describing the background and objectives of the trial The problem of orphans and abandoned children (OAC) has increasingly become a global issue mainly in war torn parts of the world as well as in many parts of poor countries where HIV/ AIDS lead to high morbidity and mortality for parents and their children. These children who develop different psychosocial problems need psychosocial interventions for promoting their psychosocial health. Narrative Therapy refers to a postmodern approach that seeks to be non-blaming and places clients as the experts of their own lives and of the stories they tell. As this approach is new in Rwanda especially in SOS Children’s Villages, very little is known about it. Thus, this study assessed the role of Narrative Therapy in reducing the behavioural problems, anxiety and increasing resilience among abandoned children from SOS Villages, Rwanda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 09/03/2020
Actual trial start date 16/03/2020
Anticipated date of last follow up 05/06/2020
Actual Last follow-up date 12/06/2020
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic (adaptive) random allocation such as minimization Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Narrative Therapy Approach The therapy included 10 sessions (two months and a half) because one session was applied weekly Rothschild defines narrative therapy as one of the forms of therapies that aims to separate the individual from the problem, allowing the individual to externalize their issues rather than internalize them. Researchers define Narrative Therapy as s a psychotherapeutic approach based on the notion that people construct narratives to define themselves and give meaning to their daily experiences and life events. Psychological suffering is viewed as a problem-saturated way of constructing life stories and a person’s identity. In simple terms, the prior authors states that the whole idea of the narrative therapy is about trauma recovery in order to improve your quality of life on a daily basis. The literature review about the use of narrative therapy in traumatic healing processes has been argued to be best fitted in healing behavioral disorders. Dulwich Centre documented that narrative therapy seeks to be a respectful, non-blaming approach to counseling and community work, which centers people as the experts in their own lives. It views problems as separate from people and assumes people have many skills, competencies, beliefs, values, commitments and abilities that will assist them to reduce the influence of problems in their lives. Morgan (2000) states that narrative therapy seeks to be a respectful, non-blaming approach to counseling and community work, which centers people, are the experts in their own lives. It views problems as separate from people and assumes people have many skills, competencies, beliefs, values, commitments and abilities that assisted them to reduce the influence of problems in their lives. White and Epston theorized that subscribing to a harmful or adverse self-identity could have profound negative impacts on a person’s functionality and quality of life. The problem is the problem; the person is not the problem. Key characteristics of the Narrative therapy are as follows respectful approach and non-blaming approach, client as the expert. 36
Control Group Blinded 10 sessions or 2.5 months for waiting. The control group included the participants who were not assigned to narrative therapy during the study. The participants were on waiting list for finding how their outcomes may be different from those who were provided intervention (narrative therapy). 36 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Being children fostered in SOS Children’s villages of Kayonza, Kigali or Byumba; - Being aged 6-12 years during the study period; - Having at least one year fostered in SOS children’s villages; - Children who did not attend Narrative Therapy for control group. - Children with severe psychiatric disorders or any other health conditions that would affect their judgment - Children who denied providing assent - Children whose mothers (guardians) refused their participation in this study Child: 6 Year-12 Year 6 Year(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/12/2019 College of Medicine and Health Sciences Institutional Review Board at the University of Rwanda
Ethics Committee Address
Street address City Postal code Country
KG 11 Ave Gasabo, Kigali Kigali 3286 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome -Our results that narrative therapy seems to contribute to a reduction of anxiety symptoms -Narrative therapy contributed to a reduction of attention deficit hyperactivity disorders symptoms - Narrative therapy seems to contribute to an increase of psychological resilience 10 sessions or 2.5 months
Primary Outcome Children in Narrative Therapy group (experimental group) indicated a significant reduction of symptoms of psychological disorders and significant increase of psychological resilience. 10 sessions or 2.5 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SOS Children 573 Kigali Rwanda Kigali 1168 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Yes KK 737 St Kigali 4285 Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Rwanda KG 11 Ave Gasabo, Kigali Kigali 3286 Rwanda University
COLLABORATORS
Name Street address City Postal code Country
Emmanuel Biracyaza KK455 Kigali Kigali 2098 Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francoise KARIBWENDE ncalifanny@gmail.com +250788621332 KG 11 Ave Gasabo, Kigali
City Postal code Country Position/Affiliation
Kigali 3286 Rwanda Researcher
Role Name Email Phone Street address
Public Enquiries Emmanuel Biracyaza biracyazaemmaus@gmail.com +250785686886 455 Kigali, Rwanda
City Postal code Country Position/Affiliation
Kigali 2098 Rwanda District Manager
Role Name Email Phone Street address
Scientific Enquiries Jean Mutabaruka batamu2003@yahoo.fr +250788891514 KG 11 Ave Gasabo, Kigali
City Postal code Country Position/Affiliation
Kigali 3286 Rwanda Senior lecturer at the University of Rwanda
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As the study is retrospectively in the registration process, we are willing able to share with you the results before it becomes published. If it is published we will also share with you the link so that you access to it. All data were included in the manuscript. Informed Consent Form,Study Protocol They may be shared in one month since it is registered. - Respecting the confidentiality since these data are primary and they should be kept in confidential ways as agreed when we were conducting the study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/06/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information