Parenting With Anxiety: Helping Anxious Parents Raise Confident Children

NCT ID: NCT04755933

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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The study is an online course (derived from an existing evidence-based face-to-face workshop designed and evaluated by the C.I) which aims to reduce symptoms of anxiety in the children of anxious parents. It is a learning tool to help parents to understand the basic processes involved in children's anxiety, to develop a calm, consistent, behaviour management style and to learn skills for responding to difficult emotion in their children.

The whole study takes place online, allowing the participants to sign up, run through some brief eligibility questions, read the study information and provide consent.

Once enrolled in the study, there is a series of baseline questionnaires. The participant also has the option to nominate someone who also knows their child well (e.g. a co-parent, a family member or close friend) to participate in the study with them and to complete a small number of questionnaires. This will help to give us a broader, more objective picture of the child, but is an optional part of the study. 48 hours later (to allow time for the participants to contact the co-respondent if they choose) the index participant will be randomised to one of two groups: either the intervention (the online course), or the control group where they do not receive the intervention.

Those in the intervention will be randomised to receive 8 out of 9 modules of the course, with a suggested time frame of one or two modules a week, each module taking about 30 minutes, with some home-practice tasks in-between.

Both the intervention group and the control group participants will be contacted again after 6 months to complete a set of follow-up questionnaires (similar to those completed at baseline). Depending on when each participant joins the trial, they may be contacted a third time towards the end of the life of the study, to complete another set of questionnaires,9-21 months after their first.

Conditions

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Child Anxiety Parent Anxiety Parental Wellbeing Child Wellbeing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Raising Confident Children Course

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Raising Confident Children Course

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* N/A
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kavli Trust

UNKNOWN

Sponsor Role collaborator

Brighton & Sussex Medical School

OTHER

Sponsor Role collaborator

University of Sussex

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam Cartright-Hatton

Role: PRINCIPAL_INVESTIGATOR

University of Sussex

Locations

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University of Sussex

Brighton, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Amy Arbon

Role: CONTACT

01273 641444

Abby Dunn

Role: CONTACT

Facility Contacts

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Amy Arbon

Role: primary

Abby Dunn

Role: backup

References

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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.

Reference Type DERIVED
PMID: 39291249 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36355406 (View on PubMed)

Other Identifiers

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ER/SC430/1

Identifier Type: -

Identifier Source: org_study_id

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