Advancing cluster randomised trials in children's therapy: a survey of the acceptability of trial behaviours to therapists and parents.

BACKGROUND: Randomised controlled trials of non-pharmacological interventions in children's therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users. METHODS: A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children's therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary. RESULTS: A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children's therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%). CONCLUSIONS: Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy.

Describing pre-appointment written materials as an intervention in the context of children's NHS therapy services: A national survey.

CONTEXT: Pre-appointment written materials, including letters and leaflets, are commonly used by healthcare organisations to deliver professional-patient interactions. The written materials potentially change patients' knowledge and behaviour as part of a healthcare intervention but have received little investigation. OBJECTIVE: To describe the content of pre-appointment written materials through a behaviour change intervention perspective. DESIGN: Mixed methods study with an online questionnaire about pre-appointment written materials and an analysis of actual materials. Questionnaire data were analysed descriptively and pre-appointment materials by qualitative framework analysis. SETTING AND PARTICIPANTS: Children's community/outpatient occupational therapy, physiotherapy and/or speech and language therapy services across the UK. Service managers/clinical leads provided data. INTERVENTION: Pre-appointment written materials. RESULTS: Questionnaire responses were received from n = 110 managers/clinical leads from n = 58 NHS organisations. Written materials (n = 64) were received from n = 24 organisations. Current materials are used by therapy services as a conduit to convey the therapy service's expectations related to: accessing the service, decision-making about care and help-giving. The materials enrol the parent and child to the therapy services' expectations by behaviour change techniques. The materials configure the parent/child expectations, knowledge and behaviour towards the therapy services' operational procedures. CONCLUSION: Pre-appointment written materials configure patients to organisations' operational procedures. The written materials currently lack support for parent/child empowerment, shared decision-making and self-management to improve health. PATIENT CONTRIBUTION: Four parents of children accessing therapy services were involved in the study. The parents shared their experiences to highlight the importance of the topic and contributed to the final research design and methods.

Ingredients and change processes in occupational therapy for children: a grounded theory study.

BACKGROUND: There is limited evidence about the effectiveness of occupational therapy interventions for participation outcomes in children with coordination difficulties. Developing theory about the interventions, i.e. their ingredients and change processes, is the first step to advance the evidence base. AIM: To develop theory about the key ingredients of occupational therapy interventions for children with coordination difficulties and the processes through which change in participation might happen. MATERIAL AND METHODS: Grounded theory methodology, as described by Kathy Charmaz, was used to develop the theory. Children and parents participated in semi-structured interviews to share their experiences of occupational therapy and processes of change. Data collection and analysis were completed concurrently using constant comparison methods. RESULTS: Five key ingredients of interventions were described: performing activities and tasks; achieving; carer support; helping and supporting the child; and labelling. Ingredients related to participation by changing children's mastery experience, increasing capability beliefs and sense of control. Parents' knowledge, skills, positive emotions, sense of empowerment and capability beliefs also related to children's participation. CONCLUSION AND SIGNIFICANCE: The results identify intervention ingredients and change pathways within occupational therapy to increase participation. It is unclear how explicitly and often therapists consider and make use of these ingredients and pathway.