Guide Intervening Early: Promoting Positive Behaviour in Young Children

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There are two study phases. Phase 2 involves random assignment to the intervention or treatment as usual. Parents are recruited into the study using a number of strategies.

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The principal recruitment pathway is through health visiting services. Information is also provided through social media as well as advertisements in community media outlets. The screening pack includes an invitation letter, an information sheet, a consent form regarding participation in Phase 1 of the study, and the screening questionnaire which comprises the SDQ, and a small number of demographic variables including caregiving status, age, and educational attainment.

Alternatively, participants can complete the same forms electronically via the study website. Families who are both eligible and interested in participating in the full study progress to phase 2. Those participants who are interested in participating in the full study are provided with an information pack for phase 2 and a date is arranged to meet with them in order to conduct the first assessment visit where appropriate.

Participants are randomized following this visit. Site-level randomization lists are prepared by a statistician using allocation and appropriate block sizes and uploaded on to the study electronic data capture system. Eligible subjects are allocated online to the next available treatment code in the appropriate randomization list. Randomization is stratified by recruitment site and by willingness and availability of both parents to be involved, versus one only.

VIPP-SD is a manualised, home-based intervention, delivered over six sessions at approximately fortnightly intervals. Each session involves two parts, the first part involves filming parent-child interactions and the second part involves giving parents focused feedback based on the filmed interactions from the previous session. The intervention is delivered by trained, supervised health practitioners, predominantly health visitors.

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The key role of the therapists is to develop a trusting relationship with the participants in the treatment arm, and to deliver the treatment in six sessions in accordance with the manual. Treatment is monitored closely for fidelity to the manual by the clinical supervisor. Therapists also provide subjective ratings of fidelity for each session. All sessions are audio-recorded and a random proportion of sessions will be assessed by an independent researcher trained in the intervention. The six treatment sessions comprise of:.

Two booster sessions: these are spaced one month apart, and the key messages are repeated using continuing video interaction material at each session. Participants in both groups will continue to receive treatment as usual. The baseline assessment includes a brief demographic interview. The primary outcome is an assessment of severity of behavioural problems using a modified version of the Preschool Parental Account of Child Symptoms Pre-PACS , a semi-structured investigator-led interview administered to a parent or caregiver.

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The modification of the Pre-PACS for this study was carried out in collaboration with one of its developers through piloting and discussion and all researchers conducting assessments received extensive training on administering the interview. The interview has previously been validated for preschool-aged children.

The Pre-PACS has high inter-rater reliability and good construct validity, and has been used in previous clinical trials e. Semi-structured interviews are the gold-standard measure for most psychiatric disorders. They are more objective as they use investigator-based criteria for scoring symptoms, and are thus less prone to parental biases, which are seen when using parent-reported questionnaires.

Interviews are recorded for reliability purposes and are assessed periodically to avoid drift and to ensure that the measure remains robust to rater and respondent bias. The latter comprises syndrome scores for attention problems and aggressive behaviours. SDQ scores from the conduct and hyperactivity scales will be combined to provide an overall externalising behavioural difficulties score.

Parent behaviour is assessed using the Parenting Scale [ 46 ], a reliable and valid measure of dysfunctional discipline practices in parents. Parental sensitivity will be rated based on video-recorded parent-child interactions, using a standardised rating scale, by raters blinded to group allocation.

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Parental mood is measured using the widely used Patient Health Questionnaire 9 PHQ-9 to index depression severity [ 48 ], while anxiety is measured using the Generalised Anxiety Disorder 7 GAD-7 [ 49 ], a seven-item generalised anxiety disorder questionnaire that has been extensively used in research as a general measure of anxiety in adults.

Parents who are allocated to the intervention arm are also asked to complete a feedback questionnaire following the 5-month assessment to explore their satisfaction with and experiences of the VIPP programme. The primary analysis will be by intention to treat ITT. Descriptive analyses, including histograms and box plots, will be used to assess the distributional assumptions and to check for possible outliers. Log transformations will be applied, where appropriate, in order to render the outcomes distributions closer to the normal. Bootstrap techniques will be used if this does not achieve reasonable normality, to the extent that this may influence the properties of the regression analysis.

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The relationship between the outcomes and other variables will be explored graphically, using scatter plots and box plots, and descriptive data will be presented in accordance with the variable type. Prior to data analysis, missingness in the baseline variables and outcomes will be investigated to assess any risk of bias and the impact on precision of estimates for the proposed statistical methods.

Sensitivity analyses modelling different assumptions for missing data will be undertaken to determine the need for supplementary multiple imputation for missing values. These analyses will account for results of any losses to follow-up insofar as they pertain to differences in measured variables i. This will enable us to effectively incorporate information gleaned from earlier follow-up times when the final follow-up outcome is absent. This will be done by incorporating outcomes at earlier time points into the predictive model for the multiple imputation of the outcome at 2-year follow-up.

Secondary outcome variables will be analysed similarly. Economic outcomes will be explored in two ways: a short-term, within-trial evaluation and a longer-term decision model. Data is recorded in interview with parents at baseline, and at the 4- and month follow up assessments, using the Child and Adolescent Service Use Schedule CA-SUS , a measure of service use designed for use in mental health populations and successfully applied in pre-school populations [ 53 ] and populations with problematic behaviour [ 54 , 55 ].

The CA-SUS has been modified to ensure relevance to the current population through review of recent literature and clinical feedback.

Data on intervention contacts and other resources are collected directly from health visitor records and indirect time time spent on preparation, supervision, administration, travel etc. National unit costs will be applied to all services [ 56 , 57 ], with the exception of the VIPP intervention, which will be costed using a micro-costing approach [ 58 ].

Within-trial analyses will include i a cost-effectiveness analysis using the primary outcome measure of the trial Pre-PACS , reporting incremental cost-effectiveness ratios and uncertainty explored using cost-effectiveness acceptability curves [ 59 , 60 , 61 ], and ii a cost-consequences analysis, outlining the costs alongside all secondary outcome measures in order to explore potential economic impacts of the intervention more broadly.

There are currently no valid preference-based measures of health-related quality of life, capable of generating quality-adjusted life years QALYs , for application to a pre-school population. It is, therefore, not possible to undertake a cost-utility analysis at this stage. However, the feasibility of using modelling to explore longer-term cost-utility will be explored, as described below. The economic implications of behavioural problems are long term in nature affecting multiple domains of well-being across the life course [ 62 , 63 ].

These longer-term outcomes will be explored using decision analytic modelling, following methods applied in similar research [ 64 ]. Data from the trial will be supplemented with data from a systematic literature review, which will attempt to locate evidence from a broader perspective, additionally including education and criminal justice sector resources, the cost of criminal activity and productivity losses.

In terms of outcomes, where data allow, effectiveness estimates in the trial will be linked to estimates of health-related quality-of-life scores, to support a cost-utility analysis.

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Decision analysis will be used to model data from the proposed trial plus existing data on costs, outcomes and probabilities from published studies [ 66 , 67 ]. The most suitable modelling framework in which to carry out the analysis will be selected, dependent upon the results of the proposed study. In cases where individuals can be regarded as independent and interaction between them is not an issue in terms of the course or progression of an illness, as is the case in the current population, either a decision tree or a Markov model may be appropriate [ 68 ].

The cost-effectiveness of the VIPP-SD versus control groups will be analysed using incremental analysis and probabilistic sensitivity analysis. It is necessary for models to build in uncertainty estimates for the probability, cost and outcome parameters used.

In this model it is likely that variability, heterogeneity and uncertainty will be important and will therefore need to be incorporated. Because many of the model parameters will be based on real data from the proposed RCT study, it will be possible to use regression models and appropriate assumptions regarding the statistical distribution of the data to handle the uncertainty [ 59 ].

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However, secondary analysis will explore longer time periods, dependent on data availability. All data will be entered on to an electronic trial database, following a standard data management protocol for data entry. A trial monitor will then check data quality. The trial will be conducted in accordance with the Data Protection Act at all times. All identifiable data will be kept strictly confidential, identifiable information will not be stored alongside any clinical data to ensure trial participants remain anonymous. It details the actions researchers, and individuals delivering the intervention are required to take to ensure participant safety, and that they receive any emergency or healthcare support needed.

All safety concerns will be reported directly to the Principal Investigator, who will put into effect any further actions required. The Principal Investigator will also provide the research team with any clinical supervision needed. All serious adverse events will be documented, and the sponsor and ethics committee will be informed.

All participants will be informed that should they wish to withdraw from the trial at any time they are able to so without giving a reason, however, any reasons provided by participants who chose to withdraw from the trial will be recorded. The results of the trial will be disseminated to participants, healthcare professionals, researchers and to the public. Participants will receive regular newsletters on the progress of the trial and a final summary report of the study findings. The trial team will consult with the Patient and Public Involvement advisory group for support on the dissemination of results to all trial participants, as well as on sharing results within services for child and families and on national parenting websites.

Stakeholders, including NHS professionals delivering the intervention, Netmums collaborators, and the Patient and Public Involvement advisory group will also receive regular updates on the trial via newsletters, media releases and a final summary report of the study results. Study reports will be submitted to the trial funders, the Health Technology Assessment HTA , at regular intervals to monitor progress, including a final report at the end of the trial. The trial team will present the progress and results of the study at relevant national and international conferences to both research and clinical audiences, including the Clinical Research Network annual conference.

A final article will be submitted to a peer-reviewed journal for publication. Phase 1 recruitment commenced in June and is ongoing.