We describe below our success in completing the objectives specified in the study protocol:
l To develop a health professional delivered parenting programme. An 8-week, group-based parenting programme designed to combine parenting skills and knowledge withfirst aid advice and safety training, and suitable for delivery in a children’s centre setting by a health professional, was developed according to our specification and delivered on time by our voluntary sector partner, Parenting UK.
l To assess the acceptability of the parenting programme to parents and professionals. Our original proposal stated that we would evaluate the parenting programme from two perspectives: parent participants, and the perspective of the health professionals delivering the programme. In addition to these perspectives, we have also evaluated the programme from an injury prevention expert
perspective, and against the Parenting Programme Evaluation Tool written by the Children’s Workforce Development Council.110Following these four evaluations we asked Parenting UK to undertake further
development work on the programme to respond to the issues raised. A print-ready version of the revised 6-week programme has been produced.
l To assess the feasibility of delivering the parenting programme against seven factors:
i. To assess recruitment and retention of parents within the trial. Using four strategies for recruitment we were able to recruit 40 of the planned 96 participants to the study using the eligibility criteria specified in the original study brief. We were also able to engage a further 11 parents using an
‘open invite’approach where there was no requirement to have a preschool child who had sustained an injury. We found that the most significant barrier to recruitment was the requirement for parents to admit that their child had been injured. Of 39 participants offered the intervention [randomised (n= 17), purposefully allocated (n= 9) and‘open invite’(n= 11)] only 15 completed the intervention, although completion was significantly greater (Fisher’s exact test,p= 0.002) using the
‘open invite’approach (85%) rather than the other two approaches (31%). Once parents started the programme retention rates were high (80% of those meeting the original eligibility criteria, and 79% of those in the‘open invite’group) suggesting that the programme itself was perceived as helpful by those attending.
ii. To assess compliance with delivery of the intervention. We asked health visitor trainers and their cofacilitators about their ability to deliver the intervention as designed during qualitative interviews and focus groups. The primary challenge for trainers was the limited capacity within the 8-week programme to respond to issues raised by the course participants while still covering the content of the programme. This was a particular challenge for one of the‘open access’groups in Nottingham where the trainer needed to accommodate the learning and social needs of the group participants. These challenges were fed back to Parenting UK and used to inform the further development work during the revision to a 6-week programme. In a future trial a formal process to assess interventionfidelity would need to be implemented to document deviations from
the programme.
iii. To determine the training, equipment and facilities needed for delivery of the parenting programme. We provided a 2-day‘train the trainer’event for the trainers and their cofacilitators providing the parenting programme as part of the feasibility trial. The training event was evaluated positively afterwards. Trainers were encouraged to take advantage of e-mail and telephone support from the programme designer at Parenting UK after delivery of each session and to provide peer support to other teams. The delivery and evaluation of the parenting programme provided opportunities to
reflect on how the‘train the trainer’event could be developed for any subsequent future trial, and week-by-week support from the developer or peers was not utilised as much as might have been anticipated. The materials and resources used during the delivery of the parenting programme were praised by the majority of users as being of high quality and engaging for parents. Each delivery team would need its own set of course resources for any subsequent trial. We anticipated delivering the four courses in children’s centres but, in practice, two courses were delivered (at least in part) in community centre venues. These venues proved equally successful, and any subsequent trial could utilise either venue according to facilities, local context and the parent participants’needs.
iv. To assess the collection of primary and secondary outcome measures. We developed and tested a tool (the injury calendar) for the collection of our primary outcome: parent-reported medically attended injuries in the index child and siblings of the index child. This proved to be acceptable to parents with 67% of parents returning calendar pages. Parents reported a large number of injuries using the tool (n= 151), both medically attended and non-medically attended, suggesting that for many of the participants the tool was not difficult to complete and that they were not concerned that they would be perceived badly by the researchers for returning a form reporting injuries in their children. Through a validation exercise we compared the parent reported medically attendances with emergency department (ED), NHS walk-in centre and GP records. We found one instance where a parent-reported NHS provider use was not found on the records searched, and four instances of NHS provider use not reported by parents returning calendar pages. Thesefindings suggest that both methods are helpful to determine child injuries during any future trial. The sensitivity of the injury calendar for collecting medically attended injuries was only 20% although this should not be overinterpreted owing to the limited number of medically attended injuries identified and the small number of parents participating in the feasibility study. The study has identified the need for greater clarity of the information for parents on how to complete the injury calendar.
During the feasibility study we made amendments to only one of ourfive non-injury secondary outcome measures. We learned that the Strengths and Difficulties Questionnaire95,96had become
validated down to the age of 2 years and we therefore used this measure in preference for younger toddlers. We used the Infant Behaviour Scale–Revised-Short Form98for children aged under 1 year.
Non-injury secondary outcome measures were collated into an A5-sized questionnaire booklets for parents, colour coded for the age of the child at entry to the study, for use at baseline and end of follow-up. These booklets were well completed by participating parents and we did not receive any feedback suggesting this format of presenting the questionnaires required amendment for any subsequent trial. We used the same child behaviour measure at follow-up as at baseline to enable a difference in scores to be estimated in both arms of the trial. However, some parents commented that infant behaviour questions used at baseline were no longer applicable at follow-up owing to the developmental progress of their child. In a future trial we would need to identify an alternative measure to assess behaviour change over periods of significant developmental change (e.g. in the first 2 years of life).
v. To determine what information to collect on‘normal care’. In our original study protocol
we proposed to compare the parenting programme intervention with‘normal care’where this was described as the actions taken by health visitor teams upon receipt of a notification of attendance at an emergency department or NHS walk-in centre for an injury. We discovered that health visitor teams have variable and locally determined‘normal care’, and that most teams are using paper-based records with no central register of receipt of notifications of injuries or action taken. The challenge of collecting‘normal care’data in a main trial, even prospectively, and the inability to pool and interpret these data owing to locally determined factors means that we would not
recommend this measure for any subsequent main trial. If the eligibility criteria for a future study were amended to any parent of a preschool child irrespective of a history of injury, then it would no
attempted to meet this study objective as originally described. The implications for a subsequent main trial are further described below.
vi. To assess which relevant resource utilisation/costing data need to be collected. We have collected detailed information on the non-recurrent costs associated with developing the parenting
programme intervention and the recurrent costs that would need to be considered in a future trial. We believe that the injury calendar developed to collect our primary outcome measure would be suitable for recording NHS provider use as an economic outcome in any future trial.
vii. To produce estimates of effect sizes to inform sample size estimation for a future trial. The low recruitment and completion rate meant that the number of medically attended injuries reported by parents was too small to make an estimate of the sample size required for a future trial. The implications of this outcome for a future trial are described below.
We have therefore met all the research objectives described in our original study proposal except the one relating to estimations of sample size for a future trial.