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AnteayerBMJ Open

Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial

Por: Williams · A. J. · Cleare · S. · Borschmann · R. · Tench · C. R. · Gross · J. · Hollis · C. · Chapman-Nisar · A. · Naeche · N. · Townsend · E. · Slovak · P. · On behalf of Digital Youth · Creswell · Fonagy · Arseneault · Lloyd · Mendes · Holter · Jirotka · Lazar · Patalay · Kelly · Ka
Introduction

Purrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.

Methods and analysis

The study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16–25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people’s own views of Purrble as an intervention device.

Ethics and dissemination

Ethical approval was received from King’s College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.

Trial registration number

NCT06025942.

Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease: protocol for a randomised controlled feasibility study

Por: Schmid · A. S. · Ehrler · M. · Wehrle · F. · Tuura · R. O. · Kretschmar · O. · Landolt · M. · Latal · B.
Introduction

Children with congenital heart disease (CHD) are at risk for executive functions (EF) impairments. To date, interventions have limited effects on EF in children and adolescents with complex CHD. Therefore, we developed a new multimodal and personalised EF intervention (E-Fit). This study aims to test the feasibility of this intervention called ‘E-Fit’ for children with complex CHD and EF impairments.

Methods and analysis

This is a single-centre, single-blinded, randomised controlled feasibility study exploring the E-Fit intervention. We aim to enrol 40 children with CHD aged 10–12 years who underwent infant cardiopulmonary bypass surgery and show clinically relevant EF impairments (T-score ≥60 on any Behaviour Rating Inventory for Executive Function questionnaire summary scale). The multimodal intervention was developed with focus groups and the Delphi method involving children and adolescents with CHD, their parents and teachers, and health professionals. The intervention is composed of three elements: computer-based EF training using CogniFit Inc 2022, performed three times a week at home; weekly EF remote strategy coaching and analogue games. The content of the computer and strategy training is personalised to the child’s EF difficulties. The control group follows their daily routines as before and completes a diary about their everyday activities four times a week. Participants will be randomised in a 1:1 ratio. Feasibility is measured by the participants’ and providers’ ratings of the participants’ adherence and exposure to the intervention, recruitment rates and the evaluation of the intended effects of the programme.

Ethics and dissemination

Local ethics committee approval was obtained for the study (BASEC-Nr: 2021-02413). Parents provide written informed consent. Key outputs from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly to participating families. Furthermore, these results will inform the decision whether to proceed to a randomised controlled trial to investigate effectiveness.

Trial registration number

NCT05198583.

Lifecourse investigation of the cumulative impact of adversity on cognitive function in old age and the mediating role of mental health: longitudinal birth cohort study

Por: Liu · Y. · Patalay · P. · Stafford · J. · Schott · J. M. · Richards · M.
Objective

To investigate the accumulation of adversities (duration of exposure to any, economic, psychosocial) across the lifecourse (birth to 63 years) on cognitive function in older age, and the mediating role of mental health.

Design

National birth cohort study.

Setting

Great Britain.

Participants

5362 singleton births within marriage in England, Wales and Scotland born within 1 week of March 1946, of which 2131 completed at least 1 cognitive assessment.

Main outcome measures

Cognitive assessments included the Addenbrooke’s Cognitive Examination-III, as a measure of cognitive state, processing speed (timed-letter search task), and verbal memory (word learning task) at 69 years. Scores were standardised to the analytical sample. Mental health at 60–64 years was assessed using the 28-item General Health Questionnaire, with scores standardised to the analytical sample.

Results

After adjusting for sex, increased duration of exposure to any adversity was associated with decreased performance on cognitive state (β=–0.39; 95% CI –0.59 to –0.20) and verbal memory (β=–0.45; 95% CI –0.63 to –0.27) at 69 years, although these effects were attenuated after adjusting for further covariates (childhood cognition and emotional problems, educational attainment). Analyses by type of adversity revealed stronger associations from economic adversity to verbal memory (β=–0.54; 95% CI –0.70 to –0.39), with a small effect remaining even after adjusting for all covariates (β=–0.18; 95% CI –0.32 to –0.03), and weaker associations from psychosocial adversity. Causal mediation analyses found that mental health mediated all associations between duration of exposure to adversity (any, economic, psychosocial) and cognitive function, with around 15% of the total effect of economic adversity on verbal memory attributable to mental health.

Conclusions

Improving mental health among older adults has the potential to reduce cognitive impairments, as well as mitigate against some of the effect of lifecourse accumulation of adversity on cognitive performance in older age.

Behavioural outcomes of children born with intrauterine growth restriction: protocol for a systematic review and meta-analysis

Por: Yakoub · N. · Reinelt · T. · Natalucci · G.
Introduction

Intrauterine growth restriction (IUGR) is a pregnancy condition, which is associated with poor perinatal outcomes and long-term neurodevelopmental impairment. Several studies also investigated the impact of IUGR on child behaviour (eg, internalising and externalising behaviour, social competencies). However, so far, no systematic review or meta-analysis has been conducted that summarises these effects while considering relevant third variables such as type of IUGR diagnosis and control group, or concurrent cognitive abilities. The objective of this study is to summarise the current evidence regarding the relationship between IUGR and behavioural outcomes from early childhood to young adulthood. Additionally, to explore how third variables such as type of control group, or cognitive abilities, relate to this association.

Methods

Search strategy: The following electronic databases will be searched—Web of Science, Medline Ovid, PsycInfo, Cochrane Library, Scopus and Embase. Inclusion criteria: observational (eg, cohort studies and case–control studies) and intervention studies (if standard care is used and norm values are reported for the control group) will be included if they quantitatively compare children with and without IUGR from the age of 2 to 18 years. The main outcomes are internalising and externalising behaviour, and social competencies.

Ethics and dissemination

No ethics approval was necessary for this protocol. Dissemination of findings will be done by publishing the results in peer-reviewed journals. The results of this systematic review will provide guidance for practice and counselling for clinicians and therapists facing patients affected by IUGR and their families.

PROSPERO registration number

CRD42022347467.

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