A randomised controlled clinical and cost effectiveness trial of an online integrated bipolar parenting intervention (IBPI) compared to treatment as usual in improving child emotional and behavioural outcomes: a study protocol
Bibliographic record
Abstract
BACKGROUND: Bipolar disorder (BD) is a severe mental health problem linked to substantial personal and social costs. Many individuals living with bipolar disorder are parents. Due to the nature of the condition, parents with BD often experience challenges in delivering consistent parenting. In addition, up to 60% of their children experience at least one mental health problem in childhood and are at increased risk of future severe mental health problems including bipolar disorder. This paper describes the rationale and protocol for a definitive randomised controlled trial of a new digital intervention (Integrated Bipolar Parenting Intervention; IBPI) to support effective parenting in the context of BD. METHODS AND DESIGN: The randomised controlled clinical and cost-effectiveness trial compares IBPI plus treatment as usual (TAU) with TAU alone. Parents with BD with a child aged 4-11 years old and living in the UK will be recruited through the NHS, mental health charities, and social media. Participants will be screened to confirm a clinical diagnosis of BD. They will then complete baseline assessments and be randomised to receive either IBPI + TAU or TAU with follow up assessments after 24- and 48- weeks. The primary clinical outcome is child emotional and behaviour problems measured by the Strengths and Difficulties Questionnaire at 24 weeks. The primary economic evaluation will be a cost-utility analysis at 24-weeks with quality-adjusted life years (QALYs) measured using the Child Health Utility 9 Dimensions measure of health-related quality of life. Secondary outcomes include parental mood and confidence and family functioning at 24- and 48- weeks, and child emotional and behavioural problems and health economic outcomes at 48 weeks. DISCUSSION: Despite the challenges faced by children of parents with BD and the parents themselves, research on how to improve their lives is lacking. This will be the first definitive trial of a tailored intervention that aims to improve child and parent outcomes. Results will be reported in line with CONSORT guidance for clinical and health economic findings. TRIAL REGISTRATION: ISRCTN Registry (ISRCTN15962574) registered on 03/05/2023.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.014 | 0.018 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.008 | 0.006 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.005 |
| Insufficient payload (model declined to judge) | 0.046 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".