[This corrects the article DOI: 10.1016/j.lanepe.2024.101038.].
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.
BackgroundThe 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.MethodsA 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.ResultsIntention 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.DiscussionThe 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 registrationThe 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).
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
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 per cent 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 behaviours are associated with reduced anxiety in their children. A brief UK-based group-based intervention delivered to parents within the UK National Health Service led to a 16 per cent reduction in children meeting criteria for an anxiety disorder. However, this intervention is not widely accessible. To widen access, a nine-module online version of this intervention has been developed. This course comprises psychoeducation and home practice delivered through text, video, animations, and practice tasks. OBJECTIVE To evaluate the feasibility of delivering a brief online intervention for parents and assess its effectiveness in reducing child anxiety symptoms. METHODS A randomised controlled trial (RCT) of a community sample of 1,754 parents with self-identified high levels of anxiety with a child aged 2-11. Parents in the intervention arm to receive access to the online course, which they undertake at a self-determined rate. The control arm receives no intervention. Follow-up data collection at 6 and 9-21 months. Intention to treat analysis will be conducted on outcomes including child anxiety, child mental health symptoms and wellbeing; parental anxiety, wellbeing; and parenting behaviours. RESULTS Funded in April 2020, recruitment started in February 2021 and projected to end October 2022. CONCLUSIONS The results of the RCT will provide evidence on the utility of an online course in preventing intergenerational transmission of anxiety and increase understanding of familial anxiety. CLINICALTRIAL Prospectively registered on ClinicalTrials.Gov NCT04755933 on Feb 16th 2021.