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.

Moderators of the Effects of a Digital Parenting Intervention on Child Conduct and Emotional Problems Implemented During the COVID-19 Pandemic: Results From a Secondary Analysis of Data From the Supporting Parents and Kids Through Lockdown Experiences (SPARKLE) Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080.

Facial Regulation During Dyadic Interaction: Interpersonal Effects on Cooperation.

This study investigated interpersonal effects of regulating naturalistic facial signals on cooperation during an iterative Prisoner's Dilemma (IPD) game. Fifty pairs of participants played ten IPD rounds across a video link then reported on their own and their partner's expressed emotion and facial regulation in a video-cued recall (VCR) procedure. iMotions software allowed us to auto-code actors' and partners' facial activity following the outcome of each round. We used two-level mixed effects logistic regression to assess over-time actor and partner effects of auto-coded facial activity, self-reported facial regulation, and perceptions of the partner's facial regulation on the actor's subsequent cooperation. Actors were significantly less likely to cooperate when their partners had defected on the previous round. None of the lagged scores based on auto-coded facial activity were significant predictors of cooperation. However, VCR variables representing partner's positive regulation of expressions and actor's perception of partner's positive regulation both significantly increased the probability of subsequent actor cooperation after controlling for prior defection. These results offer preliminary evidence about interpersonal effects of facial regulation in interactive contexts and illustrate how dynamic dyadic emotional processes can be systematically investigated in controlled settings. Supplementary Information: The online version contains supplementary material available at 10.1007/s42761-023-00208-y.

The replication crisis has led to positive structural, procedural, and community changes.

The emergence of large-scale replication projects yielding successful rates substantially lower than expected caused the behavioural, cognitive, and social sciences to experience a so-called 'replication crisis'. In this Perspective, we reframe this 'crisis' through the lens of a credibility revolution, focusing on positive structural, procedural and community-driven changes. Second, we outline a path to expand ongoing advances and improvements. The credibility revolution has been an impetus to several substantive changes which will have a positive, long-term impact on our research environment.

Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice.

BACKGROUND: Systematically screening for child anxiety problems, and offering and delivering a brief, evidence-based intervention for children who are identified as likely to benefit would minimise common barriers that families experience in accessing treatment. We have developed a short parent-report child anxiety screening questionnaire, and procedures for administering screening questionnaires, sharing screening outcomes with families, and offering and delivering a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety) through schools. This trial aims to evaluate clinical and health economic outcomes for (1) children (aged 8-9) who screen positive for anxiety problems at baseline (target population) and (2) the wider population of all children in participating classes (total population) in schools randomly allocated to receive identification-to-intervention procedures and usual school practice ('screening and intervention'), compared to assessment and usual school practice only ('usual school practice').  METHODS: The trial design is a parallel-group, superiority cluster randomised controlled trial, with schools (clusters) randomised to 'screening and intervention' or 'usual school practice' arms in a 1:1 ratio stratified according to the level of deprivation within the school. We will recruit schools and participants in two phases (a pilot phase (Phase 1) and Phase 2), with progression criteria assessed prior to progressing to Phase 2. In total, the trial will recruit 80 primary/junior schools in England, and 398 children (199 per arm) who screen positive for anxiety problems at baseline (target population). In schools allocated to 'screening and intervention': (1) parents/carers will complete a brief parent-report child anxiety screening questionnaire (at baseline) and receive feedback on their child's screening outcomes (after randomisation), (2) classes will receive a lesson on managing fears and worries and staff will be provided with information about the intervention and (3) parents/carers of children who screen positive for anxiety problems (target population) will be offered OSI. OSI will also be available for any other parents/carers of children in participating classes (total population) who request it. We will collect child-, parent- and teacher-report measures for the target population and total population at baseline (before randomisation), 4 months, 12 months and 24 months post-randomisation. The primary outcome will be the proportion of children who screen positive for anxiety problems at baseline (target population) who screen negative for anxiety problems 12 months post-randomisation. DISCUSSION: This trial will establish if systematic screening for child anxiety problems, sharing screening outcomes with families and delivering a brief parent-led online intervention through schools is effective and cost-effective. TRIAL REGISTRATION: ISRCTN registry ISRCTN76119074. Prospectively registered on 4.1.2022.

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).

Swearing as a Response to Pain: Assessing Hypoalgesic Effects of Novel "Swear" Words.

Previous research showing that swearing alleviates pain is extended by addressing emotion arousal and distraction as possible mechanisms. We assessed the effects of a conventional swear word ("fuck") and two new "swear" words identified as both emotion-arousing and distracting: "fouch" and "twizpipe." A mixed sex group of participants (N = 92) completed a repeated measures experimental design augmented by mediation analysis. The independent variable was repeating one of four different words: "fuck" vs. "fouch" vs. "twizpipe" vs. a neutral word. The dependent variables were emotion rating, humor rating, distraction rating, cold pressor pain threshold, cold pressor pain tolerance, pain perception score, and change from resting heart rate. Mediation analyses were conducted for emotion, humor, and distraction ratings. For conventional swearing ("fuck"), confirmatory analyses found a 32% increase in pain threshold and a 33% increase in pain tolerance, accompanied by increased ratings for emotion, humor, and distraction, relative to the neutral word condition. The new "swear" words, "fouch" and "twizpipe," were rated as more emotional and humorous than the neutral word but did not affect pain threshold or tolerance. Changes in heart rate and pain perception were absent. Our data replicate previous findings that repeating a swear word at a steady pace and volume benefits pain tolerance, extending this finding to pain threshold. Mediation analyses did not identify a pathway via which such effects manifest. Distraction appears to be of little importance but emotion arousal is worthy of future study.