Promoting tolerance of childrens feelings

ISRCTN	ISRCTN77196667
DOI	https://doi.org/10.1186/ISRCTN77196667
Secondary identifying numbers	11832

Submission date: 22/03/2012
Registration date: 22/03/2012
Last edited: 06/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Adela Apetroaia
Scientific

University of Reading
Department of Psychology
PO Box 238
Reading
RG6 6AL
United Kingdom

Email	a.apetroaia@reading.ac.uk

Study information

Study design	Randomised interventional treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Promoting tolerance of childrens feelings: a randomised controlled trial
Study objectives	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 childrens 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 childrens 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 childrens 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. Childrens treatment outcomes will be mediated by change in parental tolerance of childrens negative emotions.
Ethics approval(s)	ref: 12/SC/0022
Health condition(s) or problem(s) studied	Anxiety
Intervention	Guided cognitive behavioral therapy (CBT) self-help delivered via parents (four sessions, 3 face to face, 1 telephone) with adjunctive Tolerance for Childrens 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
Primary outcome measure	Primary indicator of recovery measured post treatment
Secondary outcome measures	Change in parental interactive behaviours measured at the end of study
Overall study start date	01/03/2012
Completion date	31/05/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	Planned Sample Size: 65; UK Sample Size: 65
Key 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
Key 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).
Date of first enrolment	01/03/2012
Date of final enrolment	31/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Reading

Reading
RG6 6AL
United Kingdom

Sponsor information

University of Reading (UK)
University/education

Whiteknights
PO Box 217
Berkshire
Reading
RG6 6AH
England
United Kingdom

Phone	+44 (0)118 987 5123
Email	abc@email.com
Website	http://www.reading.ac.uk/
"ROR"	https://ror.org/05v62cm79

Funders

Funder type

Research council

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No

Editorial Notes

06/03/2018: Publication reference added.
25/02/2016: No publications found, verifying study status with principal investigator.

Promoting tolerance of childrens feelings