Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial.
Frantz I., Foran HM., Lachman JM., Gardner F., McMahon RJ., Ogden T., Hutchings J., Costin MR., Kunovski I., Raleva M., Mueller J., Heinrichs N.
BACKGROUND: Clinicians and researchers should consider the expected benefits and potential harms of an intervention. Parenting programmes are a widely used evidence-based intervention for child behaviour problems. However, few data are available on potential negative effects. The aims of this paper were to increase systematic knowledge of adverse event (AE) assessment in parenting programmes and to provide an AE assessment tool. METHODS: As part of the RISE project (prevention of child mental health problems in South-eastern Europe-adapt, optimise, test and extend parenting for lifelong health), we developed and tested an AE assessment procedure in three sequential studies for parents of children with child behaviour problems aged 2 to 9 years in North Macedonia, Republic of Moldova, and Romania. This paper reports on the development of the assessment tool in phase 1 (N = 140), phase 2 (N = 835), and the final experiences with using the optimised procedures in phase 3 (multisite randomised controlled trial, N = 823) in which AEs were assessed before, three times during intervention delivery, and at 1 year follow-up. At each time point, the participants completed a 12-item AE checklist. If moderate-to-severe problems of parent or child were reported, a structured follow-up interview was conducted. RESULTS: The response rate on the AE assessment tool increased from 6% (phase 1) to 100% (phase 3) indicating improvement in collecting these data based on the experiences of each phase. Results of the RCT (phase 3) showed generally low (S)AE frequencies with the finally optimised procedure: During the intervention, no serious adverse events (SAE) were registered; at least one AE was reported by 10% (after the first session), 7% (after the third session), and 4% (after the last fifth session) of participants. None of the identified (S)AEs was causally related to the study or intervention. Cost-benefit considerations are needed to determine the best way to ensure participant safety in parenting programmes. CONCLUSION: The applied active AE assessment procedure provides a comprehensive AE assessment tool that can be used by others-with adaptations for the specific context, if needed. Based on our experiences, we outline recommendations for future studies. TRIAL REGISTRATION: ClinicalTrials.gov, registration number phase 1: NCT03552250; phase 2: NCT03865485, phase 3: NCT04721730 . Registered on 13 January 2021.