Introducing a Smart Toy in Eating Disorder Treatment: A Pilot Study.

Individuals with eating disorders (EDs) often encounter challenges related to body image, emotional, and sensory difficulties during nutritional rehabilitation. To address these challenges, a novel technology-enabled smart toy, Purrble, designed for immediate assistance in emotion regulation, is being explored. A mixed-method approach involving workshops, diaries, and focus groups was employed to examine the feasibility of Purrble as a therapeutic tool and its impact on participants' daily routines, sensory experiences, and emotional states. The study results demonstrate the engagement and acceptability of this device. Qualitative analysis revealed that participants independently used and integrated Purrble into their emotional and sensory regulation practices. These pilot results support the potential for a shift in the delivery of adjunct therapeutic tools through technology, particularly for ED patients with complex presentations. Future research is necessary to further explore the psychological benefits of this intervention.

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

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.

Investigating the Feasibility, Acceptability, and Appropriation of a Socially Assistive Robot Among Minority Youth at Risk of Self-Harm: Results of 2 Mixed Methods Pilot Studies.

BACKGROUND: Minority youth are at an increased risk of experiencing self-harmful thoughts and behaviors. However, there is limited evidence of successful interventions to support young people in the moment of their distress. Digital interventions are considered a potential solution for providing in-the-moment support for those at risk of adverse mental health and self-harm. OBJECTIVE: These pilot studies aim to investigate the feasibility and acceptability of a new in situ intervention tool, Purrble, among two broad groups of minority youth: (1) lesbian, gay, bisexual, transgender, queer, and similar minority (LGBTQ+) youth and (2) racial and ethnic minority youth. Purrble was designed to support in-situ emotion regulation (ER) support when individuals are facing emotionally challenging situations. METHODS: This study consisted of 2 mixed methods pilot studies that followed the same mixed methods design, including 3 weeks of daily and weekly surveys and optional follow-up interviews. Inclusion criteria were (1) aged between 16 and 25 years, (2) part of a minority group, (3) had experiences of self-harmful thoughts or behaviors or elevated symptoms of depression or anxiety, and (4) living in the United Kingdom at the time of the study. The primary outcomes were (1) the feasibility of Purrble as an intervention among pilot samples (analyzed by consent rate, retention rate, adherence to surveys, and engagement with the device) and (2) the acceptability and appropriation of Purrble across pilot studies as a tool to support ER in situ (thematically analyzed qualitative open-ended questions and interview data). The secondary outcomes were descriptive pilot data concerning the mental health outcomes in each sample. RESULTS: In total, 21 LGBTQ+ young people participated in pilot study 1, with 86% (n=18) completing the baseline and 3 weeks of daily surveys. These young people maintained engagement with Purrble across deployment, across which period there was a decrease in self-harmful thoughts and anxiety symptoms. A total of 19 ethnic and racial minority youths participated in pilot study 2, and 84% (n=16) completed the study. Although pilot study 2 participants also maintained engagement with Purrble across deployment, this was to a lesser degree than participants of pilot study 1, and perceived mental health outcomes did not indicate potential change associated with the device. The thematic analysis indicated three superordinate themes: (1) stopping the self-harm cycle, (2) adopting ER strategies, and (3) stages of change. CONCLUSIONS: These were the first pilot studies of a novel intervention that aimed to provide in situ ER support for young people at risk of self-harm. Both quantitative and qualitative findings indicate that young people found Purrble to be a feasible and acceptable intervention, as they effectively incorporated the device into their ER practices. These engagements with Purrble were described as interrupting the cycle of self-harmful ideation and behavior.

Feasibility, Perceived Impact, and Acceptability of a Socially Assistive Robot to Support Emotion Regulation With Highly Anxious University Students: Mixed Methods Open Trial.

BACKGROUND: Mental health difficulties among university students have been rising rapidly over the last decade, and the demand for university mental health services commonly far exceeds available resources. Digital interventions are seen as one potential solution to these challenges. However, as in other mental health contexts, digital programs often face low engagement and uptake, and the field lacks usable, engaging, evidence-supported mental health interventions that may be used flexibly when students need them most. OBJECTIVE: The aim of this study is to investigate the feasibility and acceptability of a new, in situ intervention tool (Purrble) among university students experiencing anxiety. As an intervention, Purrble was designed to provide in situ support for emotion regulation (ER)-a well-known transdiagnostic construct-directly in the moments when individuals are facing emotionally challenging situations. A secondary aim is to consider the perceived impact of Purrble on youth mental health, as reported by students over a 7-week deployment. METHODS: A mixed methods open trial was conducted with 78 under- and postgraduate students at Oxford University. Participants were recruited based on moderate to high levels of anxiety measured by Generalized Anxiety Disorder-7 at baseline (mean 16.09, SD 3.03). All participants had access to Purrble for 7 weeks during the spring term with data on their perceived anxiety, emotion dysregulation, ER self-efficacy, and engagement with the intervention collected at baseline (pre), week 4 (mid), and week 8 (postintervention). Qualitative responses were also collected at the mid- and postintervention points. RESULTS: The findings demonstrated a sustained engagement with Purrble over the 7-week period, with the acceptability further supported by the qualitative data indicating that students accepted Purrble and that Purrble was well-integrated into their daily routines. Exploratory quantitative data analysis indicated that Purrble was associated with reductions in student anxiety (dz=0.96, 95% CI 0.62-1.29) and emotion dysregulation (dz=0.69, 95% CI 0.38-0.99), and with an increase in ER self-efficacy (dz=-0.56, 95% CI -0.86 to -0.26). CONCLUSIONS: This is the first trial of a simple physical intervention that aims to provide ongoing ER support to university students. Both quantitative and qualitative data suggest that Purrble is an acceptable and feasible intervention among students, the engagement with which can be sustained at a stable level across a 7-week period while retaining a perceived benefit for those who use it (n=32, 61% of our sample). The consistency of use is particularly promising given that there was no clinician engagement or further support provided beyond Purrble being delivered to the students. These results show promise for an innovative intervention model, which could be complementary to the existing interventions.

Toward an integrated approach for mental health and psychosocial support and peacebuilding in North-East Nigeria: programme description and preliminary outcomes from 'Counselling on Wheels'.

BACKGROUND: Despite theoretical support for including mental health and psychosocial support (MHPSS) with peacebuilding, few programmes in conflict-affected regions fully integrate these approaches. AIMS: To describe and assess preliminary outcomes of the Counselling on Wheels programme delivered by the NEEM Foundation in the Borno State of North-East Nigeria. METHOD: We first describe the components of the Counselling on Wheels programme, including education and advocacy for peace and social cohesion through community peacebuilding partnerships and activities, and an MHPSS intervention open to all adults, delivered in groups of eight to ten people. We then conducted secondary analysis of data from 1550 adults who took part in the MHPSS intervention, who provided data at baseline and 1-2 weeks after the final group session. Vulnerability to violent extremism was assessed with a locally developed 80-item scale. Symptoms of common mental disorders were assessed with the Depression, Anxiety and Stress Scale (DASS-21) and Post-Traumatic Stress Disorder Scale (PTSD-8). Data were analysed through a mixed-effect linear regression model, accounting for clustering by community and adjusted for age and gender. RESULTS: After taking part in group MHPSS, scores fell for depression (-5.8, 95% CI -6.7 to -5.0), stress (-5.5, 95% CI -6.3 to -4.6), post-traumatic stress disorder (-2.9, 95% CI -3.4 to -2.4) and vulnerability to violent extremism (-44.6, 95% CI -50.6 to -38.6). CONCLUSIONS: The Counselling on Wheels programme shows promise as a model for integrating MHPSS with community peacebuilding activities in this conflict-affected region of Africa.

The Effectiveness and Cost-Effectiveness of a Universal Digital Parenting Intervention Designed and Implemented During the COVID-19 Pandemic: Evidence From a Rapid-Implementation Randomized Controlled Trial Within a Cohort.

BACKGROUND: Children's conduct and emotional problems increased during the COVID-19 pandemic. OBJECTIVE: We tested whether a smartphone parenting support app, Parent Positive, developed specifically for this purpose, reversed these effects in a cost-effective way. Parent Positive includes 3 zones. Parenting Boosters (zone 1) provided content adapted from standard face-to-face parent training programs to tackle 8 specific challenges identified by parents and parenting experts as particularly relevant for parents during the pandemic. The Parenting Exchange (zone 2) was a parent-to-parent and parent-to-expert communication forum. Parenting Resources (zone 3) provided access to existing high-quality web-based resources on a range of additional topics of value to parents (eg, neurodevelopmental problems, diet, and sleep). METHODS: Supporting Parents And Kids Through Lockdown Experiences (SPARKLE), a randomized controlled trial, was embedded in the UK-wide COVID-19: Supporting Parents, Adolescents and Children during Epidemics (Co-SPACE) longitudinal study on families' mental health during the pandemic. Parents of children aged 4 to 10 years were randomized 1:1 to Parent Positive or follow-up as usual (FAU) between May 19, 2021, and July 26, 2021. Parent Positive provided advice on common parenting challenges and evidence-based web-based resources and facilitated parent-to-parent and expert-to-parent support. Child conduct and emotional problems and family well-being were measured before randomization (T1) and at 1 (T2) and 2 (T3) months after randomization. Service use, costs, and adverse events were measured, along with app use and satisfaction. The primary outcome was T2 parent-reported child conduct problems, which were analyzed using linear mixed regression models. RESULTS: A total of 320 participants were randomized to Parent Positive, and 326 were randomized to FAU. The primary outcome analysis included 79.3% (512/646) of the participants (dropout: 84/320, 26% on Parent Positive and 50/326, 15% on FAU). There were no statistically significant intervention effects on conduct problems at either T2 (standardized effect=-0.01) or T3 (secondary outcome; standardized effect=-0.09) and no moderation by baseline conduct problems. Significant intervention-related reductions in emotional problems were observed at T2 and T3 (secondary outcomes; standardized effect=-0.13 in both cases). Parent Positive, relative to FAU, was associated with more parental worries at T3 (standardized effect=0.14). Few intervention-attributable adverse events were reported. Parent Positive was cost-effective once 4 outliers with extremely high health care costs were excluded. CONCLUSIONS: Parent Positive reduced child emotional problems and was cost-effective compared with FAU once outliers were removed. Although small when considered against targeted therapeutic interventions, the size of these effects was in line with trials of nontargeted universal mental health interventions. This highlights the public health potential of Parent Positive if implemented at the community level. Nevertheless, caution is required before making such an interpretation, and the findings need to be replicated in large-scale, whole-community studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080.

An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial.

BACKGROUND: Emotion regulation is a key transdiagnostic risk factor for a range of psychopathologies, making it a prime target for both prevention and treatment interventions in childhood. Existing interventions predominantly rely on workshops or in-person therapy-based approaches, limiting the ability to promote emotion regulation competence for children in everyday settings and at scale. Purrble is a newly developed, inexpensive, socially assistive robot-in the form of an interactive plush toy-that uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the need for a priori training. Although qualitative data from previous studies show high engagement in situ and anecdotal evidence of the robot being incorporated into children's emotion regulation routines, there is no quantitative evidence of the intervention's impact on child outcomes. OBJECTIVE: The aim of this study is to examine the efficacy of a new intervention model for child-led emotion regulation-Purrble-that can be deployed across prevention and treatment contexts. METHODS: Overall, 134 children aged 8 to 10 years will be selected from an enriched nonclinical North American population; for inclusion, the cutoff for the parents' rating of child dysregulation will be ≥10 points in the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff was selected to obtain a measurable, but not necessarily clinical, level of the child's emotion regulatory difficulties. The selected families will be randomly assigned with .5 probability to receive either a Purrble or an active control (noninteractive plush toy). The primary outcome will be a daily ecological momentary assessment measure of child emotion regulation capability (as reported by parents) over a period of 4 weeks. Exploratory analyses will investigate the intervention impact on secondary outcomes of child emotion regulation, collected weekly over the same 4-week period, with follow-ups at 1 month and 6 months postdeployment. Quantitative data will be analyzed on an intent-to-treat basis. A proportion of families (approximately 30% of the sample) will be interviewed after deployment as part of the process analysis. RESULTS: The study is funded by the UKRI Future Leaders Fellowship (MR/T041897/1) and an in-kind contribution from the Committee for Children. This study received ethical approval from the Pearl institutional review board (#18-CFC-101). Participant recruitment started in February 2021, with the 1-month deployment in April-May 2021. The results of this analysis will be published in 2022. CONCLUSIONS: This study will be the first quantitative evaluation of the efficacy of an innovative, proof-of-concept intervention model for an in situ, child-led emotion regulation intervention. Insights into the trajectory of daily changes, complemented with weekly questionnaire batteries and postdeployment interviews, will result in an in-depth understanding of whether and how the hypothesized intervention logic model works, leading to further intervention optimization. TRIAL REGISTRATION: ClinicalTrials.gov NCT04810455; http://clinicaltrials.gov/ct2/show/NCT04810455. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28914.

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families' mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children's behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. TRIAL DESIGN: SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort - Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). PARTICIPANTS: Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. INTERVENTION AND COMPARATOR: Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children's behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. MAIN OUTCOMES: Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. RANDOMISATION: Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. BLINDING (MASKING): It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. TRIAL STATUS: V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1st April 2021. Anticipated end date for recruitment: 31st July 2021. TRIAL REGISTRATION: Clinicaltrial.gov: NCT04786080 . The trial was prospectively registered on 8 March 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Young People's Attitude Toward Positive Psychology Interventions: Thematic Analysis.

BACKGROUND: Digital instantiations of positive psychology intervention (PPI) principles have been proposed to combat the current global youth mental health crisis; however, young people are largely not engaging with available resources. OBJECTIVE: The aim of this study is to explore young people's attitudes toward various PPI principles to find ways of making digital instantiations of them more engaging. METHODS: We conducted an explorative workshop with 30 young people (aged 16-21 years). They rated and reviewed 29 common PPIs. Ratings and recorded discussions were analyzed using thematic analysis. RESULTS: Some interventions were conflicting with young people's values or perceived as too difficult. Participants responded positively to interventions that fit them personally and allowed them to use their strengths. CONCLUSIONS: Values, context, strengths, and other personal factors are entangled with young people's attitudes toward digital instantiations of PPI principles.

A Smart Toy Intervention to Promote Emotion Regulation in Middle Childhood: Feasibility Study.

BACKGROUND: A common challenge with existing psycho-social prevention interventions for children is the lack of effective, engaging, and scalable delivery mechanisms, especially beyond in-person therapeutic or school-based contexts. Although digital technology has the potential to address these issues, existing research on technology-enabled interventions for families remains limited. This paper focuses on emotion regulation (ER) as an example of a core protective factor that is commonly targeted by prevention interventions. OBJECTIVE: The aim of this pilot study was to provide an initial validation of the logic model and feasibility of in situ deployment for a new technology-enabled intervention, designed to support children's in-the-moment ER efforts. The novelty of the proposed approach relies on delivering the intervention through an interactive object (a smart toy) sent home with the child, without any prior training necessary for either the child or their carer. This study examined (1) engagement and acceptability of the toy in the homes during 1-week deployments, and (2) qualitative indicators of ER effects, as reported by parents and children. In total, 10 families (altogether 11 children aged 6-10 years) were recruited from 3 predominantly underprivileged communities in the United Kingdom, as low SES populations have been shown to be particularly at risk for less developed ER competencies. Children were given the prototype, a discovery book, and a simple digital camera to keep at home for 7 to 8 days. Data were gathered through a number of channels: (1) semistructured interviews with parents and children prior to and right after the deployment, (2) photos children took during the deployment, and (3) touch interactions automatically logged by the prototype throughout the deployment. RESULTS: Across all families, parents and children reported that the smart toy was incorporated into the children's ER practices and engaged with naturally in moments the children wanted to relax or calm down. Data suggested that the children interacted with the toy throughout the deployment, found the experience enjoyable, and all requested to keep the toy longer. Children's emotional connection to the toy appears to have driven this strong engagement. Parents reported satisfaction with and acceptability of the toy. CONCLUSIONS: This is the first known study on the use of technology-enabled intervention delivery to support ER in situ. The strong engagement, incorporation into children's ER practices, and qualitative indications of effects are promising. Further efficacy research is needed to extend these indicative data by examining the psychological efficacy of the proposed intervention. More broadly, our findings argue for the potential of a technology-enabled shift in how future prevention interventions are designed and delivered: empowering children and parents through child-led, situated interventions, where participants learn through actionable support directly within family life, as opposed to didactic in-person workshops and a subsequent skills application.

Digital Life and Youth Well-being, Social Connectedness, Empathy, and Narcissism.

Youth well-being, social connectedness, and personality traits, such as empathy and narcissism, are at the crux of concerns often raised about the impacts of digital life. Understanding known impacts, and research gaps, in these areas is an important first step toward supporting media use that contributes positively to youth's happiness, life satisfaction, and prosocial attitudes and behaviors. By examining existing work addressing these issues across domains, we found that a complex interplay of individual factors, type of digital media engagement, and experiences in media contexts informs outcomes related to well-being, social connectedness, empathy, and narcissism. We argue that further research is needed to uncover how, where, when, and for whom digital media practices support positive well-being and social connectedness outcomes. Specifically, research needs to move beyond correlational studies to uncover causal connections between traits like narcissism and media use. Longitudinal studies are also needed to explore patterns of media use over time and related impacts. Further research is needed to explore how specific technologies can be designed to support positive well-being, social outcomes, and prosocial personality traits. Finally, research is needed regarding parenting, educational practices, and policies that support positive digital media use and related outcomes. Although existing research suggests that digital life has mixed potentials and effects for well-being, social connectedness, empathy, and narcissism, we provide recommendations for clinicians, policy makers, and educators in partnering with caregivers and youth to support media use that promotes positive outcomes in these areas.