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Individuals with eating disorders (ED) and co-occurring post-traumatic stress disorder (PTSD) often face difficulties with sensory overload and emotion regulation (ER), which can make treatment more complex. Assistive devices that offer real-time support are needed to enhance therapeutic interventions. This qualitative pilot study explored the engagement, acceptability, and perceived impact of Purrble, a socially assistive robot, as an adjunct tool for sensory and ER support. Nine participants (8 female, 1 non-binary, aged 20–55) were recruited from an ED service and engaged with Purrble over a 10-day period following a sensory well-being workshop. Participants recorded their use of Purrble and daily reflections in diaries and participated in a focus group. Thematic analysis revealed three themes: (1) Integration into daily life, where participants highlighted Purrble’s portability and ease of use in managing anxiety across various settings; (2) Managing PTSD-related difficulties, such as calming nightmares, reducing sensory overload, and providing emotional comfort; and (3) Challenges and improvements, where participants suggested modifications, such as adding a night mode and better sound control. This study provides preliminary evidence that an assistive device can support individuals with ED and PTSD, particularly in managing sleep disturbances, overstimulation, and feelings of emotional isolation. Further research using standardised methodologies is needed to expand on these preliminary findings.

Children's conduct and emotional problems increased during the COVID-19 pandemic. 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). 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. 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. 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. ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080.

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: 1 st April 2021. Anticipated end date for recruitment: 31 st 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 ).

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. 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. 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. 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). 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.

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. 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. 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. 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. 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.

A smartphone app, Parent Positive, was developed to help parents manage their children's conduct and emotional problems during the COVID-19 pandemic. A randomized controlled trial, Supporting Parents and Kids Through Lockdown Experiences (SPARKLE), found Parent Positive to be effective in reducing children's emotional problems. However, app effectiveness may be influenced by a range of child, family, socioeconomic, and pandemic-related factors. This study examined whether baseline factors related to the child, family, and socioeconomic status, as well as pandemic-related disruption circumstances, moderated Parent Positive's effects on child conduct and emotional problems at 1- and 2-month follow-up. This study was a secondary exploratory analysis of SPARKLE data. The data set included 646 children (4-10 years of age) with parents randomized to either Parent Positive (n=320) or follow-up as usual (n=326). Candidate baseline moderators included child age, gender, attention-deficit/hyperactivity disorder symptoms, parental psychological distress, family conflict, household income, employment status, household overcrowding, and pandemic-related disruption risk (ie, homeschooling, lockdown status, and isolation status). Child conduct and emotional problem outcomes measured at 1- (T2) and 2-months (T3) post randomization were analyzed using linear mixed-effects analysis of covariance models adjusting for baseline (T1) measure of outcome and including intervention and intervention by time point interaction terms allowing for different effects at the 2 time points. Moderation of intervention effects by baseline factors was assessed by replacing the intervention by time interaction terms with intervention by time point by baseline moderator interaction terms. Child gender was a significant moderator of the Parent Positive versus follow-up as usual effect on emotional problems (B=0.72, 95% CI 0.12-1.33; P=.02). Specifically, the effect of Parent Positive was close to significant (T2: B=-0.41, 95% CI -0.82 to 0.0004; P=.05) or significant (T3: B=-0.76, 95% CI -1.22 to -0.30; P<.001) in males only when compared with females, and males experienced a significantly larger reduction in emotional problems than females in the Parent Positive arm at the 2-month post randomization time point. None of the other investigated baseline factors moderated effects on emotional problems, and no factors moderated effects on conduct problems. This study highlights Parent Positive's potential for effectively reducing emotional problems in primary school-aged male children across a wide range of families. However, due to limited variability in the demographic background of the families, cautious interpretation is required, and replications are necessary in diverse samples with longer follow-up times. ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080.

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. 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. 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. 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. 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. ClinicalTrials.gov NCT04810455; http://clinicaltrials.gov/ct2/show/NCT04810455. PRR1-10.2196/28914.

Despite theoretical support for including mental health and psychosocial support (MHPSS) with peacebuilding, few programmes in conflict-affected regions fully integrate these approaches. 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. 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. 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). The Counselling on Wheels programme shows promise as a model for integrating MHPSS with community peacebuilding activities in this conflict-affected region of Africa.

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.

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.