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

Feasibility and clinical outcome assessments were carried out at baseline (T1), at post-treatment (T2, 9-11 weeks) and at three-month follow-up (T3).

The primary feasibility outcome measures for this study are:
1. Recruitment measured by the percentage of eligible participants who progressed from initial enquiry to treatment allocation and enrolment.
2. Retention to follow-up measured by the completeness of online data collection in each arm at post-intervention and 3- month follow-up. This will be presented as a percentage of the participants randomised.
3. Treatment compliance measured at 9-11 weeks post-randomisation by means of objective system usage data (‘participant access data’). Website use and treatment engagement were measured in the following ways:
3.1. The number of sessions completed (0-18 total) . treatment compliance)
3.2. The number of times users logged in (‘unique logins’)
3.3. The average length of time users remained logged in
3.4. The number of times individual pages were viewed
3.5. The number of interactive strategies completed
3.6. The number of participants who submitted weekly homework
3.7. The most and least accessed website components based on the module page accessed and completion rates
4. Treatment satisfaction and acceptability measured using the Internet Evaluation and Utility Questionnaire (Thorndike et al., 2008). This measure was used at T2 / post-intervention only.
5. Website satisfaction measured using six purposely constructed questions based on Ritterband’s model for intervention development (Ritterband et al., 2009). This measure was used at T2 / post-intervention only.
6. Treatment expectancies: post-randomisation, children and parents completed a measure of treatment expectancies which comprised of a visual analogue scale with anchors (0 = No help, 10 = Most help you can imagine) that asked participants to select the face and numerical anchor which shows how much they anticipate this programme might help with symptom improvement. This measure was used at T1 / baseline assessment only.

The primary clinical outcome measures for this study are:
1. Physical health (functional limitations) assessed using the Pediatric Quality of Life Inventory - Physical health subscale (PedsQL™ 4.0; Varni, 1998). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
2. Pain intensity assessed using the Wong-Baker FACES Pain Rating Scale, a six‐item ordinal faces scale (WBS) which assessed the intensity of pain from none to worst in the previous two weeks. This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.

Feasibility and clinical outcome assessments were carried out at baseline (T1), at post-treatment (T2, 9-11 weeks) and at three-month follow-up (T3).
1. Mood assessed by children and parents using the Pediatric Quality of Life Inventory – psychological health subscale-(PedsQL™ 4.0; Varni, 1998). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
2. Child health-related quality of life assessed using the Pediatric Quality of Life Inventory -(PedsQL™ 4.0; Varni, 1998). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
3. Child use of strategies to cope with pain measured using the Pediatric Quality of Life Inventory – Coping Skills Inventory (PedQL-CSI; Varni, 1996). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
4. Level of catastrophizing assessed with the Pain Catastrophising Scale-Child and Parent versions (PCS-C&P; Crombez et al., 2003). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
5. Pain-related self-efficacy assessed using the Self-efficacy for Functioning Despite Pain Scale – Child and Parent report (Bursch et al., 2006). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
Levels of parental protective behaviour assessed using the Adult Response to Children’s Symptoms–Protect Subscale- child and parent versions (Walker, Ley & Whitehead, 2006). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group.
6. Socio-demographic characteristics and condition-specific background information for the participants in each arm of the trial were recorded at baseline to determine if there were any inequalities across groups in terms of uptake, randomisation, compliance and retention. This data included age, sex, ethnic group, marital status, highest level of educational attainment, pain type and duration.
7. Adverse events: Participants were asked to respond to an open-ended question concerning potential adverse events occurring during the study at post-intervention and follow-up assessment.