Haar, Karin
El-Khani, Aala
Narotama, Narendra
Hussain, Amir
Fitri, Eva
Badrujaman, Aip
Wahyuni, Eka
Naheeaan, Shah Mohammad
Yassine, Ali
Maalouf, Wadih
Clinical trials referenced in this document:
Documents that mention this clinical trial
Family UNited: piloting of a new universal UNODC family skills programme to improve child mental health, resilience and parenting skills in Indonesia and Bangladesh
https://doi.org/10.1186/s13033-023-00602-w
Article History
Received: 5 October 2022
Accepted: 27 September 2023
First Online: 11 December 2023
Declarations
:
: The UNODC Drug Prevention and Health Branch in the Headquarters office in Vienna thoroughly reviewed and approved the study protocol. In addition, the national UNODC field offices in Dhaka, Bangladesh and in Jakarta, Indonesia as well as the associated national ministries (MoE, Ministry of Home Affairs and Ministry of Social Welfare in Bangladesh and the MoE and National Narcotics Board (BNN) in Indonesia), CSOs (DAM in Bangladesh) and a scientific institution (Jakarta State University) in Indonesia acknowledged and supported the programme as alternative to a formal ethics committee review. We designed and conducted our study based on the ethical standards developed by UNICEF and have taken all procedures into account. According to these standards, the submission of a trial such as ours is not mandatory to be submitted to a National Ethics Review Board or Institutional Review Board, however the study should be reviewed by at least 3 experts. In our case, we collaborated with a number of stakeholders, apart from the experts from UNODC, including the State University of Jakarta, where at least 3 independent researchers had reviewed the study thoroughly. In addition, experts in the respective governments in the two countries had reviewed the intervention and study. After this thorough review, the Family UNited programme has already been integrated into one of the National Narcotics Board programmes. The piloting was performed in accordance with the ethical standards of the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The Chief Investigator and the research team assured the confidentiality of participants in accordance with the Data Protection Act 1998. Each participant was assigned a unique identification number to ensure matching of all questionnaires. All data collected as part of the trial were treated as confidential and were only be viewed by members of the trial team; anonymised data were used wherever possible. All caregivers completed and signed a consent form at the first evaluation meeting. No measures were taken directly from children in Bangladesh; hence children were not required to complete an assent form. In Indonesia, caregivers signed for their children as they were below 16 years old at the time of enrolment, however children were informed about the programme and gave oral consent. In addition to written information being provided in the form of the Participant Information Sheets for the caregiver, participants were provided with a verbal explanation of the evaluation method at the first meeting and again when they attended the first data collection session.
: Not applicable.
: The authors declare that they have no competing interests. The views expressed in this Article do not necessarily reflect the views of the United Nations or its officials or Member States.