Long term effectiveness and cost-effectiveness of early behavioural interventions

University of Cambridge and Imperial College London require access to NHS England data for the purpose of the following research project: Long term effectiveness and cost-effectiveness of early mental health intervention: Follow up to the Healthy Start, Happy Start study. The NHS England data will be used to support the cost-effectiveness evaluation only.

The following is a summary of the aims of the research project provided by the University of Cambridge and Imperial College London:

“The original Healthy Start, Happy Start study was carried out to test the clinical and cost effectiveness of a Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) for parents of young children (aged 12-36 months) at risk of developing challenging behaviour.

Characteristics of challenging behaviour were assessed during the original study on the basis of scoring in the top 20% of population norms for the Strengths and Difficulties Questionnaire (SDQ). The questionnaire characterises aspects of challenging behaviour including: Restlessness, overactivity, aggressive behaviour, lying or cheating behaviour and general obedience to adult instructions.

The primary measure used in the follow-up study is the Parental Account of Childhood Symptoms (PACS). This measure has two subscales: the attention scale and the behaviour scale. The attention scale asks parents about their child’s behaviour during activities such as watching TV, reading, playing, mealtimes, and outings, specifically asking about how long their child engages with the activity, if they are restless during this time, and if they fidget during this time. The behaviour scale asks about aspects of the child’s behaviour, for example, telling lies, stealing, rudeness, aggressiveness, destructiveness, emotional outbursts, and refusal to follow instructions. It asks for the severity of the child’s behaviour and the frequency of the occurrence.

This follow-up study will assess the long-term clinical and cost-effectiveness of the intervention. The study is interested in finding out about how children’s behaviour changes as they get older. The study are particularly interested in how parents and children interact during everyday activities together and whether a programme, delivered to some families earlier in the study, is helpful in thinking about both the positive and challenging moments.

The primary objective of this follow-up study is to assess whether, compared to usual care in the NHS, a brief parenting intervention (VIPP-SD) leads to long-term lower levels of challenging behaviour in young children who are at high risk of developing these problems (children aged 6-9 years old). The study also aims to assess the cost-effectiveness of VIPP-SD compared to usual care in the long-term, which requires data on use of NHS services to estimate the cost side of the cost-effectiveness equation.”

In the follow up study, the Child and Adolescent Service Use Schedule (CA-SUS) is used to collect data directly from the families about their use of health and social care services. This is the same measure as described in the original trial. The Hospital Episodes Statistics (HES) and Emergency Care Dataset (ECDS) data will support the outcomes of the study by allowing a comparison in service use and therefore costs, between the control and intervention group. This NHS England data will be analysed alongside the directly collected CASUS data and will help if parents are unsure about the information asked for on the CASUS form, for example, if they cannot remember how many A&E appointments they have had for the participant child over the previous 3 years.

The following NHS England data will be accessed:

Hospital Episode Statistics

• Hospital Episode Statistics Admitted Patient Care, Accident & Emergency, Outpatients & Emergency Care Dataset (ECDS) – necessary to provide information hospital episodes of child participants which may be as a result of challenging behaviour and the actions as a result.

Impulsive or unpredictable behaviours as a result of challenging behaviour could lead to risk of injury, leading to increased A&E attendance or hospital admissions. This could be due to getting into fights (aggressiveness), reckless behaviour eg running into roads (restlessness, refusal to follow instructions), or causing self-harm either accidentally or intentionally (eg during temper tantrums). If the VIPP-SD intervention has been beneficial to parenting and child well-being, this may lead to a reduction in hospital attendance, either through parents ability to manage their child’s behaviour and reducing accidents/injuries occurring or by feeling more confident to deal with minor injuries (which may not require medical attention) themselves instead of presenting at A&E.

Some of the children who were screened as being at high risk of developing challenging behaviour will have now received diagnoses, such as for Autism or ADHD, or may be in the process of assessment. These children may attend more medical appointments as part of their assessment and/or support, eg therapeutic support. Processing of secondary care data linked with study data collected from participants will allow researchers to characterise hospital visits associated with challenging behaviour.

The level of the data will be identifiable – necessary as although the data flowing from NHS England to University of Cambridge will be pseudonymised using a unique study ID and will be held separately from the identifying details of cohort members, the University of Cambridge will hold the means to reidentify participant data. Therefore this data is considered identifiable.

The data will be minimised as follows:

• Limited to data for the Healthy Start, Happy Start study cohort, which recruited 300 children.

• Data for the whole cohort will be requested from the date of first participant recruitment to 5 years after the last participant was recruited. The first participant was recruited on the 23/07/2015 and the last participant was recruited on 25/07/2017. Data will therefore be requested to cover the period 23/07/2015 to 25/07/2022.

• Data requested will be for the data periods 2015/16 to 2022/23 financial years to cover the recruitment & post-recruitment period indicated above. University of Cambridge will perform additional minimisation upon receipt of the data to restrict data processed to cover from recruitment to the study to five years post recruitment.

Consent was gained from the participants parent or guardian prior to inclusion in the study.

University of Cambridge and Imperial College London are the Data Controllers for this study. University of Cambridge is the research sponsor for the follow-up study whilst Imperial College London was the controller and sponsor for the original Healthy Start, Happy Start trial. Imperial College London members of the research team maintain roles in determining study practise and processing through the Senior Study Statistician.

Both University of Cambridge and Imperial College London are the organisations responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The research study is in the public interest as studies indicate that challenging behaviour form the bulk of the burden of psychiatric morbidity in early childhood. According to the National Institute for Health and Care Excellence (NICE), about 30% of a typical GP’s child consultations are for challenging behaviour and 45% of community child health referrals are for behaviour disturbances indicating a increasing rate of young people are at risk of developing challenging behaviour characteristics and the risk of associated impacts this can have on psychiatric morbidity in early childhood. Studies suggest that challenging behaviour is one of the most common reasons for children to be referred to mental health services This study may inform decisions on earlier, more cost-effective intervention to address the needs of challenging behaviour and to develop a standard NHS care pathway for those affected.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because the data are required to better understand the long-term impacts of parent interventions on behavioural problems in children and young people and aims to produce generalisable and publicly available information to better inform future decisions over patients’ treatments or care pathways.

The funding is provided by NIHR. The funding is specifically for the Healthy Start, Happy Start follow-up study described. Funding is in place until 31/08/2023.

University College London (UCL) and Metropolitan University of Manchester are named within the protocol as having personnel involved in the study. Personnel from these organisation are not involved in decisions making relating to the use of NHS England data and will not access data shared by NHS England under this Agreement.

King’s College London is a data processor acting under the instructions of the data controllers. King’s College London’s role is limited to the role of health economists conducting cost-effectiveness analysis on the data. University of Cambridge are also processing the data. The data will be stored within the University of Cambridge’s Data Safe Haven, where processors will access and perform analysis within this environment.

The main statistician team is based at Imperial College London however it will not be involved in processing the NHS England data. The statisticians at Imperial will be conducting analysis on the data gathered directly from participants and the education data requested from the Department for Education National Pupil Database.

Parents of young children have been and will continue to be actively involved in the research process. The follow-up project’s design was developed in consultation with the original Patient and Public Involvement (PPI) group of the Healthy Start, Happy Start study. At a dedicated meeting to discuss future research plans, the PPI group strongly recommended that a long-term follow-up was important to understand how children are developing as they grow older and to provide more robust evidence about effectiveness and cost-effectiveness. PPI is also embedded within the study team, as two PPI representatives are Co-Investigators in the study. Both members have had the opportunity to review the protocol and have offered feedback on the design and content of participant materials. These two PPI representatives will continue to be active members of the Project Management Group to ensure positive study management and oversight. They will join meetings of external oversight groups, policy events, and assist with the coordination of the PPI panels.

A separate study steering committee has also been put in place with two PPI representatives as members. The study steering committee have been consulted on the discussion for proposing the use of NHS England data previously prior to this request. The study steering committee do not make decision on how the data is processed, they provide advice to those decision makers and provide updates on the study conduct to the study funder.

A PPI group has been set up at the establishment of the follow-up study. Members (parents, caregivers, educators) were recruited from health and community services across the original study sites. The group help the study team to develop materials for communicating with participants and review key participant materials. A panel of children (aged 6-9 years old) and parents was convened to advise on all aspects of the study including participant materials and data collection procedures. This included seeking opinion on the study booklets and assent forms. The PPI group is also planned to take part in organised pilot visits to meet researchers, further involvement in discussions on the dissemination of outputs including specific involvement from the child participants.

The dissemination strategy for study findings will be devised in collaboration with the PPI groups. Support and advice for best practice in PPI is sought from the Public Involvement Coordinator at Imperial Clinical Trials Unit (ICTU) and the PPI co-investigators.

University of Cambridge will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Name, Gender, Postcode and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the HES and ECDS datasets to University of Cambridge. The data will contain no direct identifying data items but will contain a unique study ID which can be used to link the data with other record level data already held by the recipient.

Upon receipt of the data, the University of Cambridge will process the data to minimise at a participant level. This will remove data prior to consent and after 5-year follow-up for each participant. The resulting dataset will be used as the analysis dataset. Data not included in the analysis dataset will be destroyed, and confirmation of destruction provided to NHS England.

The data will be stored on servers at the University of Cambridge Data Safe Haven. The data will not be transferred to any other location. The data will be accessed by authorised personnel via remote access. The data will remain on the servers at University of Cambridge at all times. The data will not leave England/Wales at any time.

Access is restricted to substantive employees or agents of the University of Cambridge and King’s College London. Imperial College London are not permitted to access the data. UCL are not permitted to access the data. All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will be linked at person record level with study data obtained from participants within the clinical trial dataset using the unique study ID. The identifying details will be stored in a separate database to the linked dataset used for analysis. The analyses described in this request will not utilise the identifying data . There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset provided by NHS England.

Health Economists from the King’s College London will analyse the data for the purposes described above. Personnel from King’s College London only get access via authorised remote access controls that require an approved visitor’s Agreement.

The expected outputs of the processing will be:

• A report of findings to NIHR for publication within NIHR Journals Library.

• Submissions to open access peer reviewed journals such as the British Medical Journal & wider clinically based journals. The majority of these plans are yet be decided.

• Key Findings Visual Animations & Study Newsletter for presentations to study participants, including caregivers

• The study also anticipates that findings may be produced into a presentation/conference of some form to be provided to an audience of academic, healthcare and policy professionals.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Public reports

• Participant newsletters & Animations shared with participants electronically.

• Reports aimed at NIHR.

• Conference presentations

The production of initial outputs is anticipated to take place in late 2023 moving into 2024.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients and families to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments & interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of the need for, effectiveness and cost-effectiveness of early preventative health and care measures for children.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work) for the effectiveness of early intervention programmes for challenging behaviour.

Managing challenging behaviours are a key concern to the NHS, but there is no clear pathway for access to evidence-based and cost-effective preventive interventions. If the follow up study demonstrates sustained effects of the intervention and is implemented in practice, it will make a considerable impact on reducing the burden and costs of challenging behaviour in children to the NHS and wider society. This would include alleviating pressure on key services such as Child and Adolescent Mental Health Services where there is an upward trend in referrals and demand consistently outstrips capacity. Existing parenting interventions for pre-school and school-age children displaying challenging behaviour show substantial long-term savings (estimated at £16425 per family). Evidence from other early interventions shown below (targeting child development more broadly), suggest that those interventions that begin earlier, such as VIPP-SD, are likely to provide an even higher return as they offer a greater opportunity to intercept psychopathology before it becomes established,

- Allen G. Early intervention: The next steps. London: The Stationery Office; 2011.

- Black MM, Walker SP, Fernald LC, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood development coming of age: Science through the life course. The Lancet. 2017;389(10064):77-90.

- Department of Health and Social Care and Department for Education. Transforming children and young people's mental health provision: A green paper. London: Department of Health and

Department for Education; 2017.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

The study will liaise with participating Trusts, the NIHR, and national organisations (including the Institute for Health Visiting, British Psychological Society, and Royal College of Psychiatrists) to ensure that national clinical and policy audiences are aware of the findings and implications for practice. In addition, the results of the effectiveness and cost-effectiveness analyses may be considered by the National Institute for Health and Care Excellence in the development of future relevant clinical guidelines. As part of this work, the study will work with the PEDAL (Play in Education, Development and Learning Research Centre) policy fellow and the study's communications team to produce a dedicated policy brief and host a roundtable event to share the study findings.

The Study Steering Committee has previously met to discuss potential output methods to be utilised should specific groups such as healthcare professionals or those involved in the development of policy propose interest in the findings of the study. These methods have been included in the expected outputs above and will seek to address interest from these areas to maximise the potential benefits.

TBC