Development and evaluation of an online version of the Feeling Better pain management programme for children and their care-givers

Abstract Background: Reasons for poor management of paediatric chronic pain include lack of access to psychological support for pain management. Research evidence is increasingly focused on online interventions as a source of treatment delivery. However, research in this field tends to focus on adolescents with chronic pain. There is a gap in our understanding of the feasibility, acceptability and benefits of such interventions for pre-adolescent children with chronic pain. Aim: The current research focuses on the adaptation and feasibility evaluation of a manual-based pain management programme for pre-adolescent children with chronic pain and their care-givers. It was proposed that a manualised pain management programme called Feeling Better could be adapted and delivered remotely to support school-age children (5-12 years) with chronic pain. Methods: The studies conducted in this research were guided by the UK Medical Research Council Framework for developing complex interventions and a stepped intervention mapping protocol. This involved a review of the evidence base and an appraisal of needs for intervention development, adoption and implementation in four separate but inter-linking studies. In Study 1, a systematic review, meta-analysis and intervention content analysis was conducted to (i) determine the effectiveness of psychological therapies delivered using information and communication technology for children and adolescents with chronic pain and (ii) identify the theoretical basis, behaviour change techniques and modes of delivery that characterise existing interventions and be associated with estimates of effect. The outcomes assessed included pain intensity, pain-related disability, psychological distress (anxiety and depression), quality of life and treatment satisfaction at post-treatment and follow-up among children and adolescents with chronic pain. In Study 2, a participative qualitative study was used to explore the lived experience of chronic pain management and the factors that influence coping behaviour from the perspective of pre-adolescent children with chronic pain and their care-givers. A 3-phase participative protocol was employed to explore experiences, barriers and facilitators of adaptive coping behaviour with separate groups of children and parents. A theoretical analysis of study findings was undertaken to explore the utility of Social Cognitive Theory as a guiding theoretical framework for intervention development. The sample consisted of 11 children aged 5-12 years, with juvenile idiopathic arthritis and 21 parents recruited from the community using offline and online strategies. In Study 3, a mixed method approach combining quantitative and qualitative methodologies was used to test the usability and acceptability of prototype versions of the adapted Feeling Better programme. A participative research process approach was combined with online user testing to explore how children perceive technology-based therapy and what design features are most likely to engage this population. A total of 24 children, aged 5-12 years with juvenile idiopathic arthritis or ehlers-danlos syndrome and 58 care-givers contributed to this mixed method, multi-phased study. The research process involved think-aloud group feedback, a 3-phase participative protocol and online user testing involving online assessment of usability and acceptability. In addition, experts in chronic pain management and intervention development reviewed the prototype and informed subsequent modifications. In Study 4, the feasibility and potential effectiveness of an online version of the Feeling Better pain management programme was evaluated in a two-arm, parallel feasibility trial. Eligible participants were randomised using variable block randomisation to one of two groups: (1) the online, cognitive behaviour therapy-based Feeling Better intervention or (2) a waitlist control group. The Feeling Better intervention was delivered online over a period of 9 weeks. The primary feasibility outcomes were: recruitment, retention, treatment adherence and satisfaction with treatment. The primary clinical outcomes were chronic pain intensity and physical limitations (physical health). Secondary clinical outcomes were mood (psychosocial health), self-efficacy, pain catastrophising, pain coping and parental protectiveness. Assessments were performed at baseline, at post-treatment and at 3-month follow-up. Findings: The systematic review (Study 1) found tentative evidence to support the effectiveness of ICT-based psychological therapies for chronic headache pain at post-treatment. Qualitative and quantitative assessment of treatment satisfaction suggests psychological therapy delivered using ICT is acceptable to children and adolescents. Treatment satisfaction was significantly higher in the treatment group compared to the control group. Interventions that excluded the BCT 6.1 ‘demonstration of the behaviour’ and entertainment modes of delivery were associated with greater estimates of effect in response to treatment compared to interventions that were perceived to have incorporated this technique. No significant differences were observed in estimates of effect based on the number or frequency of theoretical constructs, behaviour change techniques or modes of delivery identified. These results should be interpreted with caution as the quality of the included trials was considered low and lack of data prevented several planned analyses. The findings from the participative study (Study 2) suggest children and parents use a range of self-reliant, avoidant, dependent and inconsistent coping approaches. Children and parents differed in the importance they attribute to different pain coping strategies. For children, meaningful activity and goal pursuit strongly influenced engagement in active coping behaviour. For parents, strategies that facilitate emotional equilibrium and communication at home were most important. Seven common categories of barriers (support needs) and facilitators (coping preferences / targets for treatment) were separately identified by children and parents as important influences on coping behaviour and used to inform intervention development. These include i) Being active (physical capability) (ii) Things you love doing (meaningful activities), (iii) Be with Mom (coping habits), (iv) Emotion / relief from emotional distress, (v) Friends and practical help (social support / provision), (vi) Concentration (cognitive capability) and (vii) Find the right help (training). These findings validated the selection of Social Cognitive Theory as a guiding theoretical framework and helped to refine the Feeling Better prototype. The findings from mixed-method usability testing (Study 3) indicated the iteratively developed, online Feeling Better programme was acceptable and relevant from the perspective of end-users. Suggestions for improvement directly informed each iteration of the prototype website and implementation of clinical content. This study provided preliminary support for the acceptability, relevance and functionality of the online intervention. In Study 4, the adapted online version of the Feeling Better programme was found to be feasible and potentially effective for chronic pain management. The target for recruitment was exceeded. A total of 67 children with chronic pain and their care-givers were recruited. However, attrition at post-treatment was 28% and this was significantly higher at follow-up assessment. The target completion rate of 70% was achieved, a total of 48 (74%) parent-child dyads completed the programme and post-treatment assessment. Treatment satisfaction was high among those in the intervention group. Significant differences were observed between intervention and control groups across all clinical outcomes. Estimates of beneficial effect were medium to large. A significant effect of time was also observed across all outcomes except child-reported psychosocial health and pain intensity. Further feasibility testing is recommended to determine optimal intervention intensity, parental involvement and assessment of outcomes in this population. Overall these findings support the feasibility and potential effectiveness of the online version of the Feeling Better programme and a full trial is warranted. Conclusion: Study 1 suggests psychological therapy delivered using ICT for children with chronic headache has potential and further research is needed. This study characterised the previously unknown theoretical basis and core components incorporated in existing technology-mediated, paediatric chronic pain interventions. The findings of this review offer valuable information for healthcare professionals working in chronic pain services and to researchers involved in designing and evaluating information and communication technology-based interventions. Study 2 offers insight into the subjective experience of chronic pain management in a relatively neglected sub-group of the pain population using a novel research approach. This is the first study to give pre-adolescent children a voice in the development of intervention dedicated to school age children. The children and parents in this study demonstrated a relevant and valuable understanding of the process of effective pain self-management. Study 3 demonstrates the value of usability testing and a person-centred approach to intervention development. Important issues related to programme usability and acceptability were identified and addressed. Study 4 established the previously unknown feasibility and potential effectiveness of online interventions for paediatric chronic pain. A full RCT of the online Feeling Better programme was considered feasible and warranted