Condition category
Mental and Behavioural Disorders
Date applied
22/03/2012
Date assigned
22/03/2012
Last edited
25/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adela Apetroaia

ORCID ID

Contact details

University of Reading
Department of Psychology
PO Box 238
Reading
RG6 6AL
United Kingdom
-
a.apetroaia@reading.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11832

Study information

Scientific title

Promoting tolerance of children’s feelings: a randomised controlled trial

Acronym

Study hypothesis

In a randomised controlled trial of childhood anxiety in the presence of a current parental anxiety disorder, the principal research questions are the following:

Phase 1
1. In comparison to parents who receive a control intervention, parents who receive an intensive tolerance of children’s negative emotion (TCNE) intervention will:
1.1. Report lower anxiety when taking part in a stressful task with their child
1.2. Exhibit lower levels of expressed anxiety and negativity
1.3. Display lower levels of physiological arousal, when engaged in mildly stressful task with their child.
2. In comparison to children in the control condition, children of parents who receive the tolerance of children’s negative emotion (TCNE) intervention will:
2.1. Report lower levels of anxiety
2.2. Exhibit lower levels of expressed anxiety
2.3. Have reduced physiological (heart rate) arousal whilst completing a stressful task with their parent.

Phase 2
1. In comparison to children in the control condition, children of parents who receive the tolerance of children’s negative emotion (TCNE) intervention as an adjunct to standard clinic treatment will demonstrate improved treatment outcomes in terms of overall improvement, recovery from anxiety diagnosis, and reduction in anxiety symptoms.

2. Children’s treatment outcomes will be mediated by change in parental tolerance of children’s negative emotions.

Ethics approval

ref: 12/SC/0022

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Anxiety

Intervention

Guided cognitive behavioral therapy (CBT) self-help delivered via parents (four sessions, 3 face to face, 1 telephone) with adjunctive Tolerance for Children’s Negative Emotions therapy (four sessions, 3 face to face, one telephone)
OR
Eight sessions of Guided Cognitive Behaviour Therapy (CBT) self-help (6 face to face, 2 telephone) followed up after 4 months

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Primary indicator of recovery measured post treatment

Secondary outcome measures

Change in parental interactive behaviours measured at the end of study

Overall trial start date

01/03/2012

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

The trial is open to children with a current primary diagnosis of a major anxiety disorder whose parent (i.e. primary carer) also currently experiences high anxiety.

Child:
1. Aged 7 to 12 years;
2. Primary diagnosis of DSM-IV generalised anxiety disorder, social phobia, separation anxiety disorder, panic disorder/agoraphobia, or specific phobia (must be at least one current comorbid anxiety disorder).

Parent:
1. Primary carer
2. Cohabitates with child
3. Currently experiences high anxiety on basis of
3.1. Scoring above clinical cut-offs on the DASS-A
3.2. Meeting diagnostic criteria for a current major anxiety disorder
4. Male and female participants

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 65; UK Sample Size: 65

Participant exclusion criteria

Child:
1. Significant physical or intellectual impairment (including autistic spectrum disorders) that would impede treatment delivery
2. Current prescription of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least 8 weeks with agreement to maintain that dose throughout the study)

Parent:
1. Significant intellectual impairment
2. Severe comorbid disorder that requires intervention outside of BCAC (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence).

Recruitment start date

01/03/2012

Recruitment end date

31/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Reading
Reading
RG6 6AL
United Kingdom

Sponsor information

Organisation

University of Reading (UK)

Sponsor details

Whiteknights
PO Box 217
Berkshire
Reading
RG6 6AH
United Kingdom
+44 (0)118 987 5123
abc@email.com

Sponsor type

University/education

Website

http://www.reading.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

25/02/2016: No publications found, verifying study status with principal investigator.