Condition category
Mental and Behavioural Disorders
Date applied
30/07/2012
Date assigned
30/07/2012
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We have recently begun to understand how the risk for anxiety disorders is transmitted from parent to child. Part of the transmission is genetic, but a large proportion is environmentally mediated. This project will explore some key pathways through which anxiety is transmitted from anxious parent to child. These pathways are cognitive-behavioural pathways, meaning that they focus on thoughts and behaviours of parents. Although we now understand some of the pathways, we have no interventions/treatments that aim to reduce the increased risk of anxiety that such children run. One approach might be to prioritise treatment of anxiety in adults who have children. However, treatment is not always available or wanted, and there is no guarantee of success. For these reasons, a preventive/early intervention for children of anxious parents, which does not depend on the parents’ recovery, will be developed.
This study has two stages. In the first stage, we will be inviting parents and children into the lab to test how confidence and anxiety gets transmitted from parents to children, and seeing whether we can alter this. In the second stage, we will be inviting parents who suffer from anxiety to come to a one-day workshop. At this workshop we will give parents tips and advice to help them raise confident children. We will then be testing out whether this has any impact on the children.

Who can participate?
For the first stage of the project, this study aims to recruit 64 non-anxious parents and 64 parents who have a diagnosed anxiety disorder. Parents must have a child aged 5-9, who will also take part in the study. For the second stage of the study, 100 parents with an anxiety disorder will be recruited. For stage two, parents must have a child aged 3-9.

What does the study involve?
This study has two stages. In the first stage, we will be inviting parents and children into the lab to test how confidence and anxiety gets transmitted from parents to children, and seeing whether we can alter this. In the second stage, we will be inviting parents who suffer from anxiety to come to a one-day workshop. At this workshop we will give parents tips and advice to help them raise confident children. We will then be testing out whether this has any impact on the children.

What are the possible benefits and risks of participating?
We don’t think that there will be any direct benefit for the families that take part in stage one. Parents assigned to the experimental group in stage two may benefit from taking part in the group workshop. Parents will be reimbursed for their time, and children will receive a t-shirt.
We don’t think that there are any risks in taking part. Some of the tasks might involve the parents and children feeling mildly scared. However, it is emphasised that parents and children do not have to take part in any tasks that they don’t want to.

Where is the study run from?
Stage one is run at the Child Anxiety Theory and Treatment (CATT) Lab, University of Sussex. The workshops in stage two will be run in NHS seminar facilities.

When is study starting and how long is it expected to run for?
Families started taking part in January 2012 and the study will run until 2015.

Who is funding the study?
The research is being funded by the National Institute of Health Research.

Who is the main contact?
Dr Sam Cartwright-Hatton
s.cartwright-hatton@sussex.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sam Cartwright-Hatton

ORCID ID

Contact details

University of Sussex
School of Psychology
Pevensey Building
Falmer
Brighton
BN1 9QG
United Kingdom
+44 1273 872828
s.cartwright-hatton@sussex.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9414

Study information

Scientific title

Transmission of anxiety from parent to child – investigating cognitive-behavioural processes, developing and piloting a brief randomised preventative intervention

Acronym

ASPI

Study hypothesis

This research is based on the observation that children of parents who have anxiety disorders are at substantially increased risk of developing anxiety disorders themselves. Part of this risk is genetic, but a large part is due to environmental factors. In particular, we know that many anxious parents behave in ways that might help to transmit their anxiety to their children. The research comprises two studies that will explore the processes that transmit anxiety from parent to child and will develop a brief, pragmatic intervention to reduce this risk.

Stage 1 is a laboratory-based study, and will examine cognitive-behavioural processes that are hypothesised to be involved in the transmission of anxiety from parent to child. It will recruit both families where a parent has an anxiety disorder and families where they do not.
1. Self reported parenting of clinically anxious and non-anxious parents will differ
2. Observed parenting, in a fear-evoking situation, will differ between clinically anxious and non-anxious parents
3. Clinically anxious parents will exhibit greater attentional bias to child threat words than non-anxious parents
4. Clinically anxious parents will show a different pattern of errors in detecting emotion in children’s faces and voices compared to non-anxious parents

Stage 1 will also explore techniques that might be employed in a preventative intervention. Parents and children will complete a number of tasks exploring parents’ ability to: disguise their fear; change their patterns of reinforcement and verbal fear-information giving; and rapidly learn to devise fear-exposure programmes.
1. Non-anxious parents will be more successful at disguising their fear than clinically anxious parents
2. A brief (ten minute), educational intervention will improve parenting of both groups of parents when in a fear-evoking situation
3. A brief (ten minute) educational intervention will enable clinically anxious and non-anxious parents to devise acceptable fear hierarchies for managing fear in children

Stage 2 will develop and pilot an intensive, one-day, group parenting-based intervention for anxious parents. An intervention manual will be developed, taking account of existing knowledge, clinical experience, new results from the PI'’s other research, and by running exploratory workshops. It is hypothesised that anxiety at 12 months will be lower in the children of the parents who were randomised to receive the intervention, when compared to those in the control group.

Ethics approval

The NRES Committee – London – East approved the project on 18/8/2011, ref: 11/LO/0759. An amendment was approved on 1/12/2011. A second amendment was approved on 12/7/2012.

Study design

Interventional and Observational; Design type: Prevention, Cross-sectional study, stage 2: randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Anxiety; Disease: Anxiety

Intervention

In stage 1, participants with an anxiety disorder or without an anxiety disorder take part in some lab-based tasks.

In stage 2, a different group of participants are randomised to the parenting intervention or no parenting intervention.

Parenting workshop, Intensive, one-day, group parenting-based intervention for anxious parents with two follow-up telephone calls.

Follow-up length: 12 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Stage 1:
The Fear Survey Schedule for Children – Revised
The Revised Children’s Anxiety and Depression Scale

Stage 2:
Anxiety Disorders Interview Schedule for Children; Timepoint(s): 12-month follow-up

Secondary outcome measures

1. Fear Survey Schedule – Parent version
2. Fear Survey Schedule – revised – Child version
3. Spence Child Anxiety Scale – Parent Version
4. Spence Child Anxiety Scale
5. Semi-structured interview examining parental behaviour management style

Overall trial start date

13/01/2012

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents with children aged 3 to 9 years
2. For the intervention component, the parent must have an anxiety disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Stage 1: Planned sample size: 128; UK sample size: 128. Stage 2: Planned sample size: 100; UK sample size 100

Participant exclusion criteria

Stage 1
1. Parent or child has moderate to severe learning disability
2. Parent or child does not have moderately strong English

Stage 2
1. Parent or child has moderate to severe learning disability
2. Parent or child does not have moderately strong English
3. Parent has a disorder that would make participation in a group intervention problematic (e.g. severe personality disorder, uncontrolled psychosis), as determined by the referring clinician

Recruitment start date

13/01/2012

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Brighton
BN1 9QG
United Kingdom

Sponsor information

Organisation

Brighton and Sussex Medical School

Sponsor details

Medical Research Building
Biology Road Falmer
Brighton
BN1 9PS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) Grant Codes: NIHR-CDF-2010-03-036

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/11/2015: On the 27/11/2015, the study record has been edited in order to clearly show the difference between the laboratory part of the study (stage 1) and the interventional study (stage 2).