Feasibility and acceptability
Recruitment and randomisation
The first participant was enrolled on 18th December 2017 and recruitment ended on 30th October 2018. The last participant exited the trial on 30th December 2018 when the trial ended. In total, 54 participants were deemed eligible by clinicians across the five sites and invited to participate in the study. Demographics and clinical characteristics of participants at baseline by randomised group are presented in Table 1. Randomisation was evenly split across the study arms. Ten participants eligible for inclusion declined to take part (see Figure 1). Two participants withdrew from the intervention arm after baseline assessment (see Figure 1).
Of five sites, one returned detailed information about screening, eligibility and recruitment. At this site, of 41 children identified as eligible, 11 were not approached due to lack of clinic resources, eight families decided not to start taking medication or the clinician decided not to start medication then; eight did not want to take part in the study and four were initially interested but started medication before a baseline test could be carried out. This left a sample of 10 participants recruited at that clinic over a 4-month period (25% recruitment rate).
Engagement with the intervention
Completion rates for questionnaire outcome measures and QbTest decreased across the time points in each arm, for each group (see Table 2).
Protocol deviations were noted in each arm. In the intervention group, 37% (7/19) of follow-up 1 assessments were completed within the 2-4 week timeframe specified in the study protocol, and 53% (10/19) completed follow-up 2 within the 12-week timeframe. Information gained from the clinician completed pro forma in the intervention arm found that across both follow-ups, 73% (24/33 clinician responses) found QbTest was useful in determining their treatment, 18% (6) were neutral, 9% (3) stated it was not helpful. A further inspection revealed that more clinicians tended to find it helpful at follow-up 1 (76.5%, 13/17) than follow-up 2 (68.8%, 11/16).
In the control arm, the study protocol required two contacts any time within the 12 week study period: 70% (16/23) of control participants had one contact with the clinical team within 12 weeks and 30% (7/23) had two contacts within 12 weeks. No serious adverse events were reported and the side effects scores decreased in both arms from T1 to T2.
Between-group outcome measures
All results from the between-group outcome measures are presented in Table 3 and changes in outcome scores, along with 95% confidence intervals, are provided in Table 4 for all measures except the CHU9-D. Data analysis was not performed on the CHU9D as initial checks on the data revealed it was not meaningful to combine data from parent and child respondents, resulting in sample sizes that were too small for analysis. For all scales, higher scores represent greater presence of symptoms/impact. For the CGI, higher scores represent greater improvement. Figure 2 shows the difference between study arms over time on the SNAP-IV parent and teacher scales, and indicates greater improvement in change scores in the intervention arm than the control.
At follow-up 1, 55.6% (10/18) of cases in the experimental arm underwent changes to their treatment plan in comparison to only 33.3% (7/21) of cases in the control arm. At follow-up 2, the figures were more comparable with slightly fewer changes planned in the intervention arm (41.2%, 7/17) in comparison to the control (47.4%, 9/19). In all instances changes to the treatment plan involved changes to the type or dose of ADHD medication.
A comparison of medication adherence scores between the two arms revealed similar results. For those that responded, at follow-up 1, 100% (8/8) in the experimental arm and 88.8% (8/9) in the control arm reported taking their medication most/every day. At follow up 2, these figures were 87.5% (7/8) in the experimental arm and 100% (9/9) in the control arm.
Qualitative data on acceptability of the protocol and of QbTest as part of care
Eight participants agreed to be interviewed (six from the intervention group and two from the control group). All interviews were conducted with the children and young people’s primary care- givers; whilst it was initially intended that children would also be interviewed alongside their parents, this proved difficult in the initial interviews due to the young age of participants, and so the focus shifted to interviewing parents only. The characteristics of the children whose parents/primary caregivers took part in an interview are presented in Table 5. Five clinicians (from 4 of the 5 clinic sites) agreed to be interviewed; four of which were community paediatricians and one was a psychiatrist, all were female.
The interviews showed a range of challenges and benefits of using the QbTest as part of medication management. Attention was paid to what aspects of the protocol might require amendment, and which aspects were acceptable, in order to inform any subsequent trial design for a full RCT. The themes presented show the acceptability of taking part in the trial, and highlights how the Test fitted (or didn’t fit) within everyday care.
Theme 1: Acceptability of being part of a study
Separate to having QbTest form part of a person’s care, it is also important to understand the acceptability of trial procedures to families and children. This includes core elements such as randomisation and completion of multiple questionnaires. It was therefore crucial to understand how this was experienced by families.
Randomisation and recruitment
None of the participant interviews indicated concerns with randomisation and all understood they may be allocated to either study arm. Those in the intervention arm were pleased to have been randomised into that group and discussed perceived benefits of being randomised into the QbTest arm, notably, the opportunity to have additional QbTests.
‘Yeah I was fine! It’s like, sort of like, 50/50, so does it make any difference!’ P8
‘It didn’t bother me at all really. Because I mean obviously, we’ve had that additional care there with him having the three QbTests, which, as I say has been helpful for us when we noticed there was a change in his behaviour. So, you know, I was quite happy that we were put into that category.’ P1
Those in the control group also felt that their telephone consultations were helpful and indicated that there was some benefit from being in the TAU arm because this required less effort than the three QbTests in the intervention arm.
‘Yeah, yeah, it worked really well, because it was much easier than having to try and lug him there, and obviously it didn’t disrupt his routine or anything like that as well.’ P7
Completing questionnaires
Parents had no reservations about completing questionnaires and found them useful in highlighting areas of improvement or change, albeit noting there were multiple questionnaires.
‘Yeah, as I say, we noticed improvements, the forms are obviously standardised and repetitive, but yeah you can sort of see, you know, you’re making the change obviously as you’re noticing the behavioural change. So yeah, they were absolutely fine.’ P1
Theme 2: QBTest as part of care
Factoring in multiple appointments
Having QbTest as part of care meant that additional appointments were required in order to conduct tests and review results. This could provide both a challenge (in terms of additional burden) and also benefit (in terms of additional care for families, and quicker medication titration). The impact on both clinicians and families will be considered.
Scheduling three appointments within 12 weeks posed some logistical challenges for clinicians and services. The protocol required them to schedule appointments within shorter timeframes than demand on the clinics would ordinarily allow. Other considerations surrounded the use of clinic time in close succession when they might not have considered it necessary to have an appointment to monitor the medication so soon after the last appointment.
‘For one, our clinic time is very precious so we don’t have the luxury of seeing families so close, erm, together in appointments, and also I am not sure if that is clinically required.’ C3
In contrast, the primary caregivers valued the short time-frame and described it as beneficial to them and their families.
‘ I think it has been good to have that support. Because, when we have been in the past, we have had an appointment and then not been seen for months and months.’ P3
The primary caregivers in this sample were satisfied with the study’s appointment schedule but they had wider concerns regarding the time out of school that clinical appointments and QbTests required, which were not limited to the study, but also related to their overall ADHD care pathway. Whilst it was discussed that appointments before school, after school, and in school holidays would be preferable to missing school ultimately attending the appointments was considered beneficial.
‘I would have been fine, because it was for my child’s welfare, and so, you know, I would be quite happy to go to the appointment. But these appointments are all set out for before school or during school, so it is always missing education time, … so I wish they made, you know, appointments in June half term, or after-school appointments, or something like that. It would be helpful.’ P5
The clinicians also noted that clinic appointments often occur during working hours which has implications for children and young people missing school and also requires primary caregivers to take time out of work. Running multiple QbTest appointments could increase these problems.
‘Do children want to come in on a Saturday morning? Probably not! But parents, parents might find it quite useful because they are not necessarily having to take time off work.’ C5
Avoiding unnecessary workload
Whilst the implementation of QbTest undoubtedly meant conducting additional tests, clinicians voiced a preference to do this only when it was perceived to add value. Clinicians raised concerns about the requirement to conduct QbTests on all of the intervention participants. They described QbTest as one of a suite of tools they use to monitor ADHD symptoms, and felt that the additional resources required to carry out QbTests (staffing, clinic time, and test interpretation) are not necessary in routine cases but may be of use in trickier cases. Some also considered repeat QbTests to be burdensome for the children and young people.
‘… I wouldn’t think it is a great use of resources for every child with ADHD to have it in order to monitor their medication. I think it would be more helpful for the more complicated children who had, you know, other things going on as well, and where the situation wasn’t entirely clear.’ C4
‘The second follow up in the experimental arm was too much, especially for the children. A lot of the children did not want to do the QbTest, or they have one for the assessment, one for the follow up and one for the second, and, you know, some children are compliant and will just do as they are asked to do, but some really didn’t and said ‘I don’t want to do it.’ C3
An additional point raised by clinicians was that a greater number of participants could have been eligible to take part in the study if the time window of the baseline QbTest was increased. The study protocol stipulated that a QbTest conducted within 12 weeks prior to inclusion in the study could be used as the baseline QbTest. Any QbTest conducted prior to this previous 12 weeks was considered unreliable, due to potential changes in symptoms, and a new QbTest was required. Clinicians felt that this time window could be increased to widen eligibility and that this would be more in keeping with their clinical practice, where patients with a QbTest older than 12 weeks would not be requested to repeat the test before medication was prescribed.
Theme 3: Confidence and communication
QbTest was described by both groups (parents and clinicians) as increasing their confidence in the child’s treatment. Whilst clinicians didn’t perceive it as necessary in all cases, they found it particularly helpful in more complex cases (as described above).
Primary caregivers considered the repeated QbTests to be useful in increasing confidence in ongoing medication decisions as well as a tool the clinicians used to communicate changes in ADHD symptoms. They did not view the QbTests as burdensome to the children and young people, but they were considered ‘boring’ by some of the children who undertook them.
‘Yes, because I brought them home and showed my partner as well, and I have been able to explain to him what they mean and he can understand it as well, and we have been able to see the difference on that. It might just be a scribble on a piece of paper, but we can see that there is a difference.’ P3
‘He can have as many of them as they want to give him, it don’t hurt him so, it’s only 15 minutes of his life it’s not going to kill him.’ P2
Both groups voiced the potential of QbTest as an aid to communication. Parents described above how a visual representation of their child’s symptoms helped them to better understand the impact of treatment. For clinicians, similar views were expressed, and they also describe it as giving extra weight to their advice during consultations. Therefore, while the Qbtest is both an aid to communication, it is also a powerful additional ‘voice’ in the discussion. This appears to help parents be more accepting of treatment recommendations.
‘There are times when families say it [medication] doesn’t work because they are focusing on the behavioural problems which I do not expect the medication to make a huge impact on…so I use the QbTest as a way to talk to them and say ‘look changing the medication or increasing the medication is not going to make a huge difference to the behaviour which we need to address in a different way, so the QbTest is often quite helpful to have those sort of conversations.’ (C3)