The OPTIMA Trial
Children with ADHD symptoms often show challenging behaviours, such as aggression, defiance, and oppositional behaviours. These difficulties can place a significant strain on parents, affect their mental health and impact the important child-parent relationship. Often, behavioural issues are one of the main reasons parents seek specialist help for their child.
Unfortunately, long waiting times for services mean that many families receive little or no support at the time when they need it most. While parenting programmes have been shown to help, they can be difficult for families to attend or access. Digital tools, like parenting apps, may be a more accessible and flexible way to support families and potentially improve outcomes for children.
One such tool is STEPS, a parenting programme delivered through a mobile app. It is based on the New Forest Parenting Programme, a well-established, evidence- based intervention usually delivered in person. You can read more about the app on ‘The STEPS app’ page.
The OPTIMA trial tested the clinical outcomes and cost effectiveness of the STEPS app, as well as evaluating user satisfaction with the app.
The OPTIMA Trial Further Information
Pilot and Feasibility study
Before starting the full OPTIMA trial, we carried out a pilot and feasibility study (PAF). This was to assess whether we could recruit enough eligible parents to take part in the trial and produce meaningful findings.
A key feature of this initial study was testing a new approach to trial recruitment using myHealthE, a digital system already used in routine clinical care. myHealthE enabled parents of children on NHS waiting lists to complete a screening questionnaire without leaving their home, and to give their consent online to be contacted by a researcher.
The PAF showed that it was feasible to recruit parents into a trial using this method. We successfully reached a diverse group of participants and all parents reported being satisfied, or very satisfied, with the study process, including the use of online forms for data collection.
The pilot study also gave us an opportunity to test the STEPS app with a small group of parents (n = 12). Their feedback was positive: they found the app helpful and easy to use as a digital parenting support tool.
You can read more about the PAF study, including detailed results and information on participant demographics here.
Trial method
For those interested in the finer detail of the trial delivery, please see our published trial protocol.
Simply put, OPTIMA is a randomised controlled trial where all participants are split into one of two groups: those who received the STEPS app vs. the control group. Those in the STEPS group were given access to the app for 3 months at the start of their time on the trial. Then all participants, including the control group, were given 3- months’ access to the app at the end of their time in the trial.
All participants had to meet certain eligibility criteria and give their consent to take part. They were in the trial for 12 months and were asked to complete a series of online questionnaires every three months. These questionnaires asked parents about their child’s behaviour and wellbeing, their own emotional health and their relationship with their child, amongst other topics. Parents were given a small monetary reward for completing each set of questionnaires.
Parents and their child were also given the opportunity to take part in a virtual activity session with a researcher. This session used the Etch-A-Sketch Online’ drawing task, and you can read more about this part of the trial in our blog ‘ESO Drawing task’.
To give context to all this data, we have also conducted several interviews with parents and clinicians. Click here to read the protocol for this element of the trial.
* Watch this space for a publication on the findings of these interviews *
Recruitment and retention of participants
The OPTIMA study was run in selected children’s health services (see ‘Collaborators’ page for full list). Parents whose child had been recently referred to their local services and accepted onto their waiting list for assessment were screened. We used two explanatory videos to help explain the trial to potential participants.
796 parents in all were identified as eligible for OPTIMA and were invited to take part in the study. The 391 parents that went on to complete a consent form were then asked to complete an initial set of baseline questionnaires, before being officially recruited into the OPTIMA study.
Between May 2022 and July 2023, 352 parents were recruited into the study. The last parents completed their time on the trial in August 2024. Retention of participants throughout the trial was high, ranging from 91% (n = 319) at 3 months to 74% (n = 262) at the end of the 12 months.
Research Questions
The primary research question for the OPTIMA Trial is whether the STEPS app can reduce the severity of children’s oppositional and defiant behaviour, as rated by parents. There were also several secondary and exploratory outcomes.
These included whether STEPS could reduce other ADHD-related symptoms in children and whether the app had an effect on parents’ emotional wellbeing and the parent-child relationship. Importantly, the trial also looked at whether STEPS would be a cost- effective intervention.
Results
Expected Late Spring 2025 – watch this space!
Parents' feedback
Testimonials and parents’ feedback about the STEP app
