Evidence map›Paper›PMID 39154169›Full record

Trial reportTrials2024

Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial.

Inga Frantz, Heather M Foran, Jamie M Lachman, Frances Gardner, Robert J McMahon, Terje Ogden, Judy Hutchings, Madalina Ruxandra Costin, Ivo Kunovski, Marija Raleva and 2 more

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03552250 nacompletednot on this map

Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health

TypeinterventionalSponsorTechnische Universitaet BraunschweigRan2018 to 2018Enrolled140ConditionsChild Mental DisorderArmsParenting for Lifelong Health for Young Children
NCT03865485 nacompletednot on this map

RISE- Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health - A Factorial Study (Phase 2 of MOST)

TypeinterventionalSponsorUniversity of BremenRan2019 to 2020Enrolled835ConditionsChild Mental DisorderArmsParenting for Lifelong Health (PLH)
NCT04721730 nacompletednot on this map

Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test, and Extend Parenting for Lifelong Health ' - 'RISE' - The Randomized Controlled Trial (Phase 3 of MOST)

TypeinterventionalSponsorUniversity of BremenRan2020 to 2022Enrolled823ConditionsChild Mental DisorderArmsPLH-YC, Lecture
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Inga FrantzDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology, Universität Hamburg, Hamburg, Germany. inga.frantz@uni-hamburg.de.ORCID http://orcid.org/0000-0001-7541-2606
Heather M ForanInstitute of Psychology, University of Klagenfurt, Klagenfurt, Austria.
Jamie M LachmanDepartment of Social Policy and Intervention, University of Oxford, Oxford, England, UK.
Frances GardnerDepartment of Social Policy and Intervention, University of Oxford, Oxford, England, UK.
Robert J McMahonSimon Fraser University, Burnaby, Canada and BC Children's Hospital, Vancouver, Canada.
Terje OgdenNorwegian Center for Child Behavioral Development, University of Oslo, Oslo, Norway.
Judy HutchingsSchool of Psychology, Bangor University, Bangor, UK.
Madalina Ruxandra CostinDepartment of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania.
Ivo KunovskiInstitute for Marriage, Family and Systemic Practice - ALTERNATIVA, Skopje, Macedonia.
Marija RalevaInstitute for Marriage, Family and Systemic Practice - ALTERNATIVA, Skopje, Macedonia.
Janina MuellerInstitute of Psychology, University of Klagenfurt, Klagenfurt, Austria.
Nina HeinrichsDepartment of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.

Funding

H2020 Societal Challenges 779318
6 · The paper itself

Abstract

backgroundClinicians 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.

methodsAs 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.

resultsThe 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.

conclusionThe 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 registrationClinicalTrials.gov, registration number phase 1: NCT03552250; phase 2: NCT03865485, phase 3: NCT04721730 . Registered on 13 January 2021.

Indexed as

Child BehaviorParentingChecklistChildChild Behavior DisordersChild, PreschoolFemaleHumansMaleMoldovaParent-Child RelationsParentsRisk AssessmentRomaniaTime FactorsTreatment OutcomeAdverse eventsHarmsNegative effectParenting programmePrevention

Identifiers

PMID39154169
PMCPMC11330034

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.