Effectiveness of an unguided modular online intervention for highly anxious parents in preventing anxiety in their children: a parallel group randomised controlled trial.

Background: Children whose parents have anxiety problems are at increased risk of developing anxiety themselves. Parenting behaviors are a contributing factor to intergenerational transmission. Interventions which seek to limit anxiogenic parenting behaviors have shown potential in reducing anxiety in offspring but are not widely accessible. This prevention trial aimed to establish the effectiveness of an unguided modular online intervention for highly anxious parents in preventing anxiety in their children. Methods: A parallel group, block-randomised controlled trial of unblinded participants in a 1:1 ratio was conducted to compare efficacy of the online course compared to a no-intervention control. The intervention comprised 8 modules, of approximately 20 min each, and participants progressed through the course at their own pace. The study was conducted entirely online with a self-referred UK-based community sample of parents (child 2-11 years) with substantial anxiety. The primary outcome measure was change in parent-reported child anxiety, as measured by the Spence Children's Anxiety Scale-Parent Report (SCAS-P) or Spence Pre-School Anxiety Scale-Parent Report (Preschool SCAS). Secondary outcomes were child internalising, externalising, and attentional symptoms (Pediatric Symptom Checklist), and parent anxiety (SCARED-Adult). Analyses using complete case analysis following intention to treat principles investigated intervention effects at 6 months (primary analysis) and additionally at 9 to 25-months' follow-up. Trial registration: ClinicalTrials.GovNCT04755933, https://clinicaltrials.gov/ct2/show/NCT04755933. Findings: 1811 participants (intervention = 900; control = 911; 92.7% (1677/1810) female; 85.3% (1535/1800) White-British; 66.8% (1201/1799) university educated). Participant retention (based on primary outcome completion) at T2 (6-months post consent) was 67.6% overall (n = 1224) and substantially lower in the intervention arm 57.3% ((516/900) control = 77.8% (708/910)). Child anxiety was lower in the intervention group compared to control at 6-month follow-up (adjusted effect size estimate -0.15 (95% CI: -0.23 to -0.08, p < 0.001). There was very strong evidence that those in the intervention arm had lowered child anxiety (standardised SCAS score) compared to the control arm, with an effect size (Cohen's d) of -0.16 (95% CI: -0.23 to -0.08, p < 0.001). The difference in standardised Spence Child Anxiety Scale score between the arms was -0.15 standard deviations. On the original scales for SCAS-P (0-114) and Preschool SCAS (0-112), this corresponds to a reduction of -2.38 (95% CI: -3.59 to -1.16) and -2.68 (95% CI: -4.05 to -1.31), respectively. No reported harms. Interpretation: A clinically unsupported online intervention designed for parents with high levels of anxiety is effective in reducing anxiety and internalising symptoms in their children, and also anxiety in parents. Given the low resource intensity of this intervention, and the positive effects reported here, these findings suggest it has promise in limiting the intergenerational transmission of severe anxiety. Funding: This work was supported by Kavli Trust (grant 38/19).

Developing a hope-focused intervention to prevent mental health problems and improve social outcomes for young women who are not in education, employment, or training (NEET): A qualitative co-design study in deprived coastal communities in South-East England.

Young women who are not in education, employment, or training (NEET) experience poorer health and social outcomes compared to non-NEET young women and to NEET young men, especially in deprived areas with intersecting inequalities. The evidence on effective public health approaches is scarce. Interventions that target hope, which NEET young women notably lack, offer a promising theory-driven and intuitive means to prevent mental health problems and improve social outcomes. Hope can be defined as a goal-focused mindset comprising self-agency (motivation and self-belief) and pathways (identifying routes to achieving goals). Hope is implicated in a variety of evidence-based psychosocial interventions for young people, but is not directly targeted by existing prevention programmes for NEET populations. The current study used a phased qualitative research design and participatory methods to model a hope-focused intervention for NEET young women. Phase 1 investigated population needs and intervention parameters through semi-structured interviews with 28 key informants living or working in disadvantaged coastal communities in South-East England. The sample comprised eight NEET young women, four family members, and 16 practitioners from relevant support organisations. Phase 2 refined intervention parameters and outcomes through co-design sessions with four NEET young women, followed by a theory of change workshop with 10 practitioners. The resulting intervention model is articulated as a mentor-supported, in-person psychosocial intervention that builds hope by enhancing positive sense of self and time spent in meaningful activities, before explicitly teaching the skills needed to identify, set, and pursue personally meaningful goals.

Self-directed digital interventions for the improvement of emotion regulation-effectiveness for mental health and functioning in adolescents: protocol for a systematic review.

INTRODUCTION: Research suggests that problems with emotion regulation, that is, how a person manages and responds to an emotional experience, are related to a range of psychological disorders (eg, bipolar disorder, anxiety and depression). Interventions targeting emotion regulation have been shown to improve mental health in adults, but evidence on related interventions for adolescents is still emerging. Increasingly, self-directed digital interventions (eg, mobile apps) are being developed to target emotion regulation in this population, but questions remain about their effectiveness. This systematic review aimed to synthesise evidence on current self-directed digital interventions available to adolescents (aged 11-18 years) and their effectiveness in addressing emotion regulation, psychopathology and functioning (eg, academic achievement). METHODS AND ANALYSIS: Several electronic databases will be searched (eg, MEDLINE, PsycINFO, ACM Digital Library) to identify all studies published any time after January 2010 examining self-directed digital interventions for adolescents, which include an emotion regulation component. This search will be updated periodically to identify any new relevant research from the selected databases. Data on the study characteristics (eg, author(s)) and methodology, participant characteristics (eg, age) and the digital interventions used to address emotion (dys-)regulation (eg, name, focus) will be extracted. A narrative synthesis of all studies will be presented. If feasible, the effectiveness data will be synthesised using appropriate statistical techniques. The methodological quality of the included studies will be assessed with the Effective Public Health Practice Project quality assessment tool. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. Findings will be disseminated widely via peer-reviewed publications and presentations at conferences related to this field. REGISTRATION DETAILS: PROSPERO CRD42022385547.

Investigating the effect of providing monetary incentives to participants on completion rates of referred co-respondents: An embedded randomized controlled trial.

Background: The use of a second informant (co-respondent) is a common method of identifying potential bias in outcome data (e.g., parent-report child outcomes). There is, however, limited evidence regarding methods of increasing response rates from co-respondents. The use of financial incentives is associated with higher levels of engagement and follow-up data collection in online surveys. This study investigated whether financial incentives paid to index participants in an online trial of a parenting-focused intervention, would lead to higher levels of co-respondent data collection. Methods: A study within a trial (SWAT) using a parallel group RCT design. Participants in the host study (an RCT of an online intervention) were randomised into one of two SWAT arms: received/did not receive a £15 voucher when referred co-respondent completed baseline measures. Primary outcome was completion (No/Yes) of Spence Children's Anxiety Scale (SCAS or SCAS-Pre) at baseline. Additional analysis explored impact of incentives on data quality. Results: Intention to treat analysis of 899 parents (183 co-respondents) in the no-incentive arm, and 911 parents (199 co-respondents) in incentive arm. Nomination of co-respondents was similar between incentive arms. The RR for the incentive arm compared to the no incentive arm was 1.13 (95% CI: 0.91 to 1.41, p = 0.264) indicating that incentives did not impact completion of outcomes by consented co-respondents. There were no indications of different data quality between arms. Discussion: The finding that payment of financial incentives to index participant does not lead to greater levels of co-respondent outcome completion suggests that careful consideration should be made before allocating resources in this way in future trials. Trial registration: The host study was registered at Study Record | ClinicalTrials.gov and the SWAT study was registered in the SWAT Store | The Northern Ireland Network for Trials Methodology Research (qub.ac.uk): SWAT number 143: Filetoupload,1099612,en.pdf (qub.ac.uk).

The impact of family interventions on communication in the context of anxiety and depression in those aged 14-24 years: systematic review of randomised control trials.

BACKGROUND: The ability to communicate is integral to all human relationships. Previous research has specifically highlighted communication within families as both a risk and protective factor for anxiety disorders and/or depression. Yet, there is limited understanding about whether communication is amenable to intervention in the context of adolescent psychopathology, and whether doing so improves outcomes. AIMS: The aim of this systematic review was to determine in which contexts and for whom does addressing communication in families appear to work, not work and why? METHOD: We pre-registered our systematic review with PROSPERO (identifier CRD42022298719), followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and assessed study quality with the Risk of Bias 2 tool. RESULTS: Seven randomised controlled trials were identified from a systematic search of the literature. There was significant heterogeneity in the features of communication that were measured across these studies. There were mixed findings regarding whether family-focused interventions led to improvements in communication. Although there was limited evidence that family-focused interventions led to improvements in communication relative to interventions without a family-focused component, we discuss these findings in the context of the significant limitations in the studies reviewed. CONCLUSIONS: We conclude that further research is required to assess the efficacy of family-focused interventions for improving communication in the context of anxiety and depression in those aged 14-24 years.

Barriers and facilitators of community-based implementation of evidence-based interventions in the UK, for children and young people's mental health promotion, prevention and treatment: rapid scoping review.

BACKGROUND: Community-based organisations continue to take on a greater role in supporting children and young people in the UK with their mental health. However, little evidence exists on the capacity and capability of these settings to effectively implement evidence-based interventions (EBIs). AIMS: To identify barriers and facilitators of the implementation of EBIs within community settings in the UK, for children and young people's mental health promotion, prevention and treatment. METHOD: A PRISMA-guided, rapid scoping review was conducted, using predefined criteria and a relevant search strategy on eight databases: Ovid EMBASE, Ovid Medline, Ovid PsycINFO, Ovid Global Health: Scopus, Web of Science All Databases, EBSCO CINAHL and EBSCO ERIC. Study characteristics and data on barriers and facilitators were extracted, with results narratively synthesised. RESULTS: Five out of 4899 studies met the inclusion criteria, addressing the barriers and facilitators of community-based implementation of EBIs for children and young people's mental health promotion, prevention and treatment. All of the studies that were identified focused on school settings, but we identified no studies that included data on barriers or facilitators of implementing EBIs in other community-based or voluntary sector settings. CONCLUSIONS: There is a lack of available evidence on the capacity and capability of community settings in the UK to effectively implement EBIs and adhere to evidence-based practice. However, existing findings within schools have highlighted key barriers and facilitators to implementation, such as the importance of meaningful involvement of stakeholders throughout the research process, and greater allocation of resources to support evidence-based decision-making in these settings.

Effectiveness of a Web-Based Intervention to Prevent Anxiety in the Children of Parents With Anxiety: Protocol for a Randomized Controlled Trial.

BACKGROUND: Anxiety is the most common childhood mental health condition and is associated with impaired child outcomes, including increased risk of mental health difficulties in adulthood. Anxiety runs in families: when a parent has anxiety, their child has a 50% higher chance of developing it themselves. Environmental factors are predominant in the intergenerational transmission of anxiety and, of these, parenting processes play a major role. Interventions that target parents to support them to limit the impact of any anxiogenic parenting behaviors are associated with reduced anxiety in their children. A brief UK-based group intervention delivered to parents within the UK National Health Service led to a 16% reduction in children meeting the criteria for an anxiety disorder. However, this intervention is not widely accessible. To widen access, a 9-module web-based version of this intervention has been developed. This course comprises psychoeducation and home practice delivered through text, video, animations, and practice tasks. OBJECTIVE: This study seeks to evaluate the feasibility of delivering this web-based intervention and assess its effectiveness in reducing child anxiety symptoms. METHODS:  This is the protocol for a randomized controlled trial (RCT) of a community sample of 1754 parents with self-identified high levels of anxiety with a child aged 2-11 years. Parents in the intervention arm will receive access to the web-based course, which they undertake at a self-determined rate. The control arm receives no intervention. Follow-up data collection is at months 6 and months 9-21. Intention-to-treat analysis will be conducted on outcomes including child anxiety, child mental health symptoms, and well-being; parental anxiety and well-being; and parenting behaviors. RESULTS: Funding was received in April 2020, and recruitment started in February 2021 and is projected to end in October 2022. A total of 1350 participants have been recruited as of May 2022. CONCLUSIONS: The results of this RCT will provide evidence on the utility of a web-based course in preventing intergenerational transmission of anxiety and increase the understanding of familial anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04755933; https://clinicaltrials.gov/ct2/show/NCT04755933. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40707.

A randomised controlled trial to compare clinical and cost-effectiveness of an online parent-led treatment for child anxiety problems with usual care in the context of COVID-19 delivered in Child and Adolescent Mental Health Services in the UK (Co-CAT): a study protocol for a randomised controlled trial.

BACKGROUND: In the context of COVID-19, NHS Child and Adolescent Mental Health Services (CAMHS) and other children's mental health services have faced major challenges in providing psychological treatments that (i) work when delivered remotely and (ii) can be delivered efficiently to manage increases in referrals as social distancing measures have been relaxed. Anxiety problems are a common reason for referral to CAMHS, children with pre-existing anxiety problems are particularly vulnerable in the context of COVID-19, and there were concerns about increases in childhood anxiety as schools reopened. The proposed research will evaluate the clinical and cost-effectiveness of a brief online parent-led cognitive behavioural treatment (CBT) delivered by the OSI (Online Support and Intervention for child anxiety) platform with remote support from a CAMHS therapist compared to 'COVID-19 treatment as usual' (C-TAU) in CAMHS and other children's mental health services throughout the COVID-19 pandemic. METHODS: We will conduct a two-arm, multi-site, randomised controlled non-inferiority trial to evaluate the clinical and cost-effectiveness of OSI with therapist support compared to CAMHS and other child mental health services 'COVID-19 treatment as usual' (C-TAU) during the COVID-19 outbreak and to explore parent and therapists' experiences. DISCUSSION: If non-inferiority is shown, the research will provide (1) a solution for efficient psychological treatment for child anxiety disorders while social distancing (for the COVID-19 context and future pandemics); (2) an efficient means of treatment delivery as 'normal service' resumes to enable CAMHS to cope with the anticipated increase in referrals; and (3) a demonstration of rapid, high-quality evaluation and application of online interventions within NHS CAMHS to drive forward much-needed further digital innovation and evaluation in CAMHS settings. The primary beneficiaries will be children with anxiety disorders and their families, NHS CAMHS teams, and commissioners who will access a potentially effective, cost-effective, and efficient treatment for child anxiety problems. TRIAL REGISTRATION: ISRCTN ISRCTN12890382 . Registered prospectively on 23 October 2020.

The Youth Patient and Public Involvement Café-A youth-led model for meaningful involvement with children and young people.

INTRODUCTION: There are few meaningful frameworks or toolkits that exist for involvement with young people. Coproduction is a more recent patient and public involvement (PPI) approach that emphasizes the importance of power-sharing, to set young people as equal partners in the research process. This paper explores the successes and challenges encountered by one coproduced PPI space for young people. METHODS: This paper is written by a team of young people who developed and worked on the Youth PPI Café over a period of 18 months. It explores how we developed a youth-led space for involvement in research. The authors have reflected on their experiences, providing examples of how youth PPI and coproduction were delivered in the NHS, in practice. RESULTS: By working 'with' young people, rather than 'for' them, we offer insights into the successes and challenges of an entirely youth-led involvement space. Despite being effective in shaping mental health research for children and young people, we faced challenges with tokenism, resourcing and diversity and inclusion. CONCLUSIONS: Involving youth meaningfully in research has the potential to inform studies at a macro- and microlevel, enabling positive change within research and within the systems that support young people. PATIENT OR PUBLIC CONTRIBUTION: Young people aged 16-24 years with lived experience were included at every stage of this project, from formulation to the delivery and development of the group, to the preparation of this manuscript and its dissemination. Sussex Partnership NHS Foundation Trust's charity 'Heads On' provided funding for this study.

Parental eating disorders: A systematic review of parenting attitudes, behaviours, and parent-child interactions.

A substantial proportion of adults with eating disorders are parents. Studies suggest these parents may experience a range of parenting challenges, and their children may be at an increased risk for the development of eating disorders themselves. With parenting practices being one potential environmental mechanism for the intergenerational transmission of eating disorders, we systematically searched Scopus, Web of Science, PubMed, MEDLINE, PsychINFO, and PsychArticles for controlled studies in which parenting attitudes, behaviours, and parent-child interactions were examined for parents with and without probable eating disorders. 26,512 abstracts were screened, and 167 full-text manuscripts were retrieved, with 33 studies meeting the review inclusion criteria. Studies suggest that parents with eating disorders experience higher levels of parenting stress than control parents, and may on average be more intrusive, less sensitive, and provide less structuring/facilitation in non-feeding interactions with their children. These parents also appear, on average, to experience increased concern about their children's weight, and parent-child mealtime interactions may be problematic and characterised by high levels of conflict. Suggestions for future research are made with a view to enhancing understandings of the intergenerational transmission of eating disorders, which may lead to the identification of intervention targets for parents with eating disorders and their children.

Intra-arterial renal infusion of autologous mesenchymal stem cells for treatment of chronic kidney disease in cats: Phase I clinical trial.

BACKGROUND: There are no known treatments that halt or reverse chronic kidney disease (CKD) in cats. In rodent models, stem cell treatment has been associated with improvement in renal function parameters, especially when stem cells were delivered intra-arterially to the kidney. To date, only IV and intrarenal stem cell infusions have been studied in cats with CKD with no clinically relevant improvement noted. OBJECTIVE: To assess the safety and feasibility of intra-arterial delivery of autologous mesenchymal stem cells (MSC) in stromal vascular fraction (SVF) to the kidney in cats with CKD. ANIMALS: Five client-owned domestic cats with International Renal Interest Society stage III CKD. METHODS: Prospective cohort study (phase I clinical trial). Adipose tissue was harvested from study animals on day 0. On days 2 and 14, an infusion of MSC in SVF was administered into the renal artery via the femoral or carotid artery using fluoroscopic guidance. Serum creatinine and blood urea nitrogen concentration, plasma iohexol clearance, and quality of life assessments were monitored between days 0 and 90. RESULTS: The procedure was performed successfully in all cats. No severe adverse events were observed in any cat during the study period. CONCLUSIONS AND CLINICAL IMPORTANCE: Intra-arterial infusion of MSC into the renal artery in CKD cats was feasible and safe within a 3-month postoperative period. Efficacy and long-term safety have yet to be established. This procedure requires careful technique and training.