Effectiveness of an unguided modular online intervention for highly anxious parents in preventing anxiety in their children: a parallel group randomised controlled trial.
Anxiety
Child anxiety
Digital health
Parenting
Randomised controlled trial
Journal
The Lancet regional health. Europe
ISSN: 2666-7762
Titre abrégé: Lancet Reg Health Eur
Pays: England
ID NLM: 101777707
Informations de publication
Date de publication:
Oct 2024
Oct 2024
Historique:
received:
09
02
2024
revised:
01
08
2024
accepted:
07
08
2024
medline:
18
9
2024
pubmed:
18
9
2024
entrez:
18
9
2024
Statut:
epublish
Résumé
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. 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. 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. 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. This work was supported by Kavli Trust (grant 38/19).
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
This work was supported by Kavli Trust (grant 38/19).
Identifiants
pubmed: 39291249
doi: 10.1016/j.lanepe.2024.101038
pii: S2666-7762(24)00205-9
pmc: PMC11405817
doi:
Banques de données
ClinicalTrials.gov
['NCT04755933']
Types de publication
Journal Article
Langues
eng
Pagination
101038Informations de copyright
© 2024 The Authors.
Déclaration de conflit d'intérêts
All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare no support from any organisation for the submitted work beyond payments received through the grant awarded by the KAVLI Trust. PL has grant funding from Wellcome Trust and Economic and Social Research Council, all other authors have no financial relationships with any organisations that might have an interest in the submitted work in the previous three years. SB is participant on the following Boards (ACER (NIHR130693); NEON (NIHR RP-PG-0615-20016); ODDESSI (NIHR RP-PG-0615-2002)) all other authors have no other relationships or activities that could appear to have influenced the submitted work. SC-H designed the digital intervention which this trial evaluated, and funded its development.