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 childrens 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 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
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 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
Phase
Drug names
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 trial start date
01/03/2012
Overall trial end date
31/05/2013
Reason abandoned (if study stopped)
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
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
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
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034014/