NCT04755933

Brief Summary

This is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. The parents will be randomised to the intervention or a control group with no intervention. The intervention itself will undergo a component analysis to determine whether some modules are more effective than others.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,508

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

February 2, 2021

Last Update Submit

May 18, 2022

Conditions

Keywords

Parenting

Outcome Measures

Primary Outcomes (1)

  • Change in child anxiety

    Measured using the Spence Children's Anxiety Scale (SCAS-P and Preschool SCAS if the child is aged 6 or under). SCAS-P: Minimum 0 Maximum 114. A higher total score is indicative of higher level of child anxiety. T scores used to indicate clinical levels of anxiety however this is a screen not a diagnostic instrument. SCAS Preschool: Minimum 0 Maximum 112. A higher total indicates a higher level of pre-school child anxiety. A score of 1SD above the mean for a subscale or the total score indicates clinical investigated would be warranted.

    Baseline, 6 months, and up to 21 months.

Secondary Outcomes (6)

  • Change in parent anxiety and parental wellbeing

    Baseline, 6 months, and up to 21 months.

  • Change in parent anxiety and parental wellbeing

    Baseline, 6 months, and up to 21 months.

  • Change in child wellbeing and health

    Baseline, 6 months, and up to 21 months.

  • Change in child wellbeing and health

    Baseline, 6 months, and up to 21 months.

  • Change in anxiogenic parenting behaviours

    Baseline, 6 months, and up to 21 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

An online learning tool, designed to helps parents develop a calm, consistent behaviour management style, whilst learning skills to discourage children's avoidance.

Behavioral: Raising Confident Children Course

Control

NO INTERVENTION

The participants in the control arm will not receive access to the online course, but will complete the same sets of questionnaires at each of the timepoints.

Interventions

An online learning tool consisting of 8 different modular components, designed to reduce the transmission of anxiety from parents to children. The modular components include: a core starter about anxiety, the role of avoidance, using play to develop childrens confidence, using Emotion Coaching with children, managing difficult behaviour, the role of sleep, exercise and diet, reducing overprotection, modelling confident behaviour and managing difficult behaviour.

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be a parent (any gender, adoptive/biological/step/foster/grandparent) aged 16+, of a child aged 2 to 11 years (inclusive). The index parent must have at least 50 days' contact with the index child per year and confirm that they see enough of the child to report on the child's current anxiety level.
  • Index parent must be a UK resident.
  • Self-report subjectively substantial levels of current or lifetime anxiety.
  • Able to commit to completion of measures at (up to) three time points even if allocated to the control arm.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sussex

Brighton, BN1 9RH, United Kingdom

RECRUITING

Related Publications (2)

  • Dunn A, Alvarez J, Arbon A, Bremner S, Elsby-Pearson C, Emsley R, Jones C, Lawrence P, Lester KJ, Morson N, Simner J, Thomson A, Cartwright-Hatton S. Effectiveness of an unguided modular online intervention for highly anxious parents in preventing anxiety in their children: a parallel group randomised controlled trial. Lancet Reg Health Eur. 2024 Sep 4;45:101038. doi: 10.1016/j.lanepe.2024.101038. eCollection 2024 Oct.

  • Dunn A, Alvarez J, Arbon A, Bremner S, Elsby-Pearson C, Emsley R, Jones C, Lawrence P, Lester KJ, Majdandzic M, Morson N, Perry N, Simner J, Thomson A, Cartwright-Hatton S. Effectiveness of a Web-Based Intervention to Prevent Anxiety in the Children of Parents With Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 10;11(11):e40707. doi: 10.2196/40707.

Study Officials

  • Sam Cartright-Hatton

    University of Sussex

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 16, 2021

Study Start

February 15, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Data will not be shared on an individual basis. Anonymised study data will be archived at the end of the study through the University of Sussex data repository, Figshare.

Locations