Factors affecting adolescents’ participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project

Saarijärvi, Markus; Wallin, Lars; Moons, Philip; Gyllensten, Hanna; Bratt, Ewa‐Lena

doi:10.1186/s12874-020-01088-7

Cited by 11 publications

(6 citation statements)

References 61 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In a previous study, 43% of adolescent participants who met the diagnostic criteria for moderate to severe depression suggested that helping others and contributing to wider understanding was their main motivation for participating in a randomised clinical trial [ 56 ]. Similarly, Saarijärvi et al, [ 57 ] found adolescents with more complex conditions felt grateful towards research and the healthcare system and were thus motivated to ‘give back’. A population with a specific common interest (e.g., a medical condition) could potentially have more altruistic motivations.…”

Section: Discussionmentioning

confidence: 99%

Recruitment and retention into longitudinal health research from an adolescent perspective: a qualitative study

Jong

Stevenson

Winpenny

et al. 2023

BMC Med Res Methodol

View full text Add to dashboard Cite

Background High quality longitudinal studies investigating changes in health behaviours over the transition into early adulthood are critical. However, recruiting and retaining adolescents is challenging. This study explored adolescents’ perspectives of signing up to and continuing involvement in a hypothetical longitudinal health research study. Methods Forty-eight individuals (15-20y) participated in nine in-person focus groups about recruitment and retention in research. Participants were (a) school students in the last year of compulsory school (Year 11, 15-16y), (b) school/college students in Sixth Form (Year 13, 17-18y), (c) Further Education students studying after secondary education, but not higher education (16-18y) and (d) young adults not in education, employment, or training (18-20y) across England. Thematic analysis resulted in seven themes. Results Driving factors for sign-up included social connection e.g., joining with peer groups, personalised feedback, and incentives, primarily financial. Key barriers were lack of interest, the perception of commitment, and timing of recruitment. Young people preferred recruitment processes via social media with messages tailored to their motivations, monthly data collection of maximally 20–30 min, and hybrid data collection with some in-person contact with a consistent, non-judgemental researcher. The provision of autonomy, choice, and financial incentives were perceived to promote retention. Conclusions Adolescent recruitment and retention strategies need to align with contemporary interests and motivations. Studies should involve adolescents early to develop a planned, systematic approach to participant sign-up and follow-up. Effective and ineffective recruitment and retention strategies should be reported as part of study findings. Future research should trial how perceived barriers to study engagement can be overcome.

show abstract

Section: Discussionmentioning

confidence: 99%

Recruitment and retention into longitudinal health research from an adolescent perspective: a qualitative study

Jong

Stevenson

Winpenny

et al. 2023

BMC Med Res Methodol

View full text Add to dashboard Cite

show abstract

“…Indeed, only a third of adolescents in the transition program participated during the information day. Potential reasons for this are that adolescents with a CC might feel uncomfortable in engaging with others in the same situation and spend excessive time thinking about their illness [ 29 , 30 ]. Within patient empowerment, the ability to enable others is a core construct [ 14 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

Implementation fidelity of a transition program for adolescents with congenital heart disease: the STEPSTONES project

Saarijärvi

Wallin

Moons

et al. 2022

BMC Health Serv Res

Self Cite

View full text Add to dashboard Cite

Background Although transition programs have been evaluated for adolescents with chronic conditions, these have rarely involved process evaluations. Indeed, outcomes of complex interventions are dependent on how the intervention is implemented in practice and evaluations of implementation process are therefore pivotal. The aim of this study was to evaluate the extent to which a transition program for adolescents with congenital heart disease was delivered as intended. Research questions were 1) to what level of fidelity was the program delivered? and 2) what potential moderating factors affected the delivery of the program and overall fidelity? Methods A mixed methods design was used, where a process evaluation was embedded in the STEPSTONES randomized controlled trial in Sweden. The implementation fidelity framework by Carrol (2007) and Hasson (2010) was used to design, collect and analyze data. Quantitative data consisted of intervention records on adherence and were analyzed with descriptive statistics. Qualitative data on moderators affecting fidelity were collected through interviews, log-books and focus group interviews with healthcare professionals implementing the intervention and participatory observations of the implementation process. Data were analyzed with deductive content analysis. Triangulation was used to integrate quantitative and qualitative data within the fidelity framework. Results Six out of eight components of the transition program were delivered to an extent that adhered to the program theory or achieved a high level of fidelity. However, components involving peer support had a low attendance by the participating sample (32.2%), and the joint transfer meeting was challenging to implement, despite achieving high adherence. Moderators affecting the implementation process were the adolescent’s and healthcare professional’s engagement in the intervention, contextual factors and a lack of standard operating procedures for all components in the program. Conclusion Barriers and facilitators for a future implementation of transition programs have been illuminated in this study. The use of an implementation fidelity framework in the process evaluation proved successful in providing a comprehensive evaluation of factors affecting the implementation process. However, implementation fidelity must be considered in relation to adaptations to the local and personal prerequisites in order to create interventions that can achieve fit.

show abstract

“…For instance, several participants did not attend the information day due to feeling uncomfortable about interacting with other adolescents’ with CHD. Previous studies have shown that adolescents lack of engagement in their illness affects study participation negatively [ 15 ]. In addition, group dynamic and not being able to identify with the role models during the information day were seen as shortcomings.…”

Section: Discussionmentioning

confidence: 99%

“…A qualitative explorative design was employed. This study was part of a larger process evaluation study [ 11 , 15 ]. The planning and reporting of this study followed the Consolidated Criteria for Reporting Qualitative studies (COREQ) checklist [ 16 ] (Additional file 1 ).…”

Section: Methodsmentioning

confidence: 99%

Mechanisms of impact and experiences of a person-centred transition programme for adolescents with CHD: the Stepstones project

Saarijärvi

Wallin

Moons

et al. 2021

BMC Health Serv Res

Self Cite

View full text Add to dashboard Cite

Background During the past decade there has been some evaluation of transition programmes for adolescents with chronic conditions. However, this has rarely involved process evaluations focusing on mechanisms leading to outcomes, thus hampering implementation of these complex interventions. Our aim was to (I) describe adolescents’ and parents’ experiences of participating in a person-centred transition programme aiming to empower them in transition to adulthood and (II) explore the mechanisms of impact. Methods A qualitative process evaluation was performed, embedded in a randomized controlled trial evaluating the effectiveness of a transition programme for adolescents with congenital heart disease in Sweden. A purposive sample of 14 adolescents and 12 parents randomized to the intervention group were interviewed after participation in the programme. Data were analysed deductively and inductively in NVivo v12. Results Experiences of participation in the transition programme were generally positive. Meeting a transition coordinator trained in person-centred care and adolescent health and embarking on an educational process based on the adolescents’ prerequisites in combination with peer support were considered key change mechanisms. However, support to parents were not sufficient for some participants, resulting in ambivalence about changing roles and the unmet needs of parents who required additional support. Conclusions Participants experienced increased empowerment in several dimensions of this construct, thus demonstrating that the transition programme was largely implemented as intended and the evidence-based behaviour-change techniques used proved effective in reaching the outcome. These findings can inform future implementation of transition programmes and illuminate challenges associated with delivering a complex intervention for adolescents with chronic conditions.

show abstract

Factors affecting adolescents’ participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project

Cited by 11 publications

References 61 publications

Recruitment and retention into longitudinal health research from an adolescent perspective: a qualitative study

Recruitment and retention into longitudinal health research from an adolescent perspective: a qualitative study

Implementation fidelity of a transition program for adolescents with congenital heart disease: the STEPSTONES project

Mechanisms of impact and experiences of a person-centred transition programme for adolescents with CHD: the Stepstones project

Contact Info

Product

Resources

About