Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents

BackgroundChildren and adolescents with mentally ill parents represent an at-risk population for developing mental disorders themselves. Internet- and mobile-based interventions (IMIs) have been demonstrated to be an effective, scalable, and temporally and geographically independent method of treatm...

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Main Authors: P. Dülsen, K. Barck, S. Wiegand-Grefe, A. Leidger, T. Paumen, H. Baumeister
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Digital Health
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Online Access:https://www.frontiersin.org/articles/10.3389/fdgth.2025.1526995/full
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author P. Dülsen
K. Barck
S. Wiegand-Grefe
A. Leidger
T. Paumen
H. Baumeister
author_facet P. Dülsen
K. Barck
S. Wiegand-Grefe
A. Leidger
T. Paumen
H. Baumeister
author_sort P. Dülsen
collection DOAJ
description BackgroundChildren and adolescents with mentally ill parents represent an at-risk population for developing mental disorders themselves. Internet- and mobile-based interventions (IMIs) have been demonstrated to be an effective, scalable, and temporally and geographically independent method of treatment delivery. However, evidence for IMIs aimed at children and adolescents remains limited and inconclusive, especially for children of mentally ill parents. Therefore, the present trial aimed to evaluate the effectiveness of a mental health IMI (iCHIMPS) for children of parents with a mental illness. Due to insufficient recruitment, however, this article will primarily focus on lessons learned from the challenges encountered during the study’s implementation.MethodsThe IMI was targeted at children aged 12–18 years, regardless of whether they exhibited symptoms of mental disorders, provided that at least one parent had a diagnosed mental illness. To evaluate the effectiveness, the IMI was provided to one group [intervention group (IG)] while the control group received treatment as usual (TAU). At four measurement timepoints, the primary outcome (Youth Self-Report—YSR 11-18R) and various secondary outcomes were assessed. Recruitment from May 2021 to April 2023 initially took place at 21 participating mental health clinics throughout Germany and was later supplemented by various additional clinics as well as recruitment pathways.ResultsIn total, n = 22 participants were recruited. This result was far off the needed number of participants to meaningfully conduct any analyses. Therefore, no quantitative analyses were conducted, and this trial is discussed as a failed trial, providing important insights into ineffective strategies for reaching adolescents of parents with mental illnesses, in particular, and adolescents through digital interventions more generally.ConclusionThe identified reasons for the failed recruitment include the complex study design, particularly the presence of multiple concurrent trials recruiting from the same population, the inherent difficulty of reaching families with mentally ill parents, and the limitation of targeting the IMI solely at adolescents rather than involving families more broadly. Additionally, the design may not have been sufficiently engaging or appealing to adolescents. These reasons are discussed along with the implications for future IMI research involving children and adolescents. Clinical Trial Registrationidentifier (DRKS00025158).
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spelling doaj-art-51672eaae2c6444a8047233a07b192342025-08-20T03:32:23ZengFrontiers Media S.A.Frontiers in Digital Health2673-253X2025-07-01710.3389/fdgth.2025.15269951526995Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parentsP. Dülsen0K. Barck1S. Wiegand-Grefe2A. Leidger3T. Paumen4H. Baumeister5Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Psychiatry and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, GermanyDepartment of Psychiatry and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, GermanyDepartment of Psychiatry and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyBackgroundChildren and adolescents with mentally ill parents represent an at-risk population for developing mental disorders themselves. Internet- and mobile-based interventions (IMIs) have been demonstrated to be an effective, scalable, and temporally and geographically independent method of treatment delivery. However, evidence for IMIs aimed at children and adolescents remains limited and inconclusive, especially for children of mentally ill parents. Therefore, the present trial aimed to evaluate the effectiveness of a mental health IMI (iCHIMPS) for children of parents with a mental illness. Due to insufficient recruitment, however, this article will primarily focus on lessons learned from the challenges encountered during the study’s implementation.MethodsThe IMI was targeted at children aged 12–18 years, regardless of whether they exhibited symptoms of mental disorders, provided that at least one parent had a diagnosed mental illness. To evaluate the effectiveness, the IMI was provided to one group [intervention group (IG)] while the control group received treatment as usual (TAU). At four measurement timepoints, the primary outcome (Youth Self-Report—YSR 11-18R) and various secondary outcomes were assessed. Recruitment from May 2021 to April 2023 initially took place at 21 participating mental health clinics throughout Germany and was later supplemented by various additional clinics as well as recruitment pathways.ResultsIn total, n = 22 participants were recruited. This result was far off the needed number of participants to meaningfully conduct any analyses. Therefore, no quantitative analyses were conducted, and this trial is discussed as a failed trial, providing important insights into ineffective strategies for reaching adolescents of parents with mental illnesses, in particular, and adolescents through digital interventions more generally.ConclusionThe identified reasons for the failed recruitment include the complex study design, particularly the presence of multiple concurrent trials recruiting from the same population, the inherent difficulty of reaching families with mentally ill parents, and the limitation of targeting the IMI solely at adolescents rather than involving families more broadly. Additionally, the design may not have been sufficiently engaging or appealing to adolescents. These reasons are discussed along with the implications for future IMI research involving children and adolescents. Clinical Trial Registrationidentifier (DRKS00025158).https://www.frontiersin.org/articles/10.3389/fdgth.2025.1526995/fullInternet- and mobile-based interventione-healthonline interventionchildren and adolescentsmentally ill parents
spellingShingle P. Dülsen
K. Barck
S. Wiegand-Grefe
A. Leidger
T. Paumen
H. Baumeister
Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents
Frontiers in Digital Health
Internet- and mobile-based intervention
e-health
online intervention
children and adolescents
mentally ill parents
title Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents
title_full Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents
title_fullStr Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents
title_full_unstemmed Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents
title_short Lessons to be learned from an attempted RCT: iCHIMPS—an online intervention for adolescents with mentally Ill parents
title_sort lessons to be learned from an attempted rct ichimps an online intervention for adolescents with mentally ill parents
topic Internet- and mobile-based intervention
e-health
online intervention
children and adolescents
mentally ill parents
url https://www.frontiersin.org/articles/10.3389/fdgth.2025.1526995/full
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