Promoting tolerance of children’s feelings

ISRCTN ISRCTN77196667
DOI https://doi.org/10.1186/ISRCTN77196667
Protocol serial number 11832
Sponsor University of Reading (UK)
Funder Medical Research Council
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

a.apetroaia@reading.ac.uk

Study information

Primary study designInterventional
Study designRandomised interventional treatment
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titlePromoting tolerance of children’s feelings: a randomised controlled trial
Study objectivesIn 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(s)ref: 12/SC/0022
Health condition(s) or problem(s) studiedAnxiety
InterventionGuided 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 typeBehavioural
Primary outcome measure(s)

Primary indicator of recovery measured post treatment

Key secondary outcome measure(s)

Change in parental interactive behaviours measured at the end of study

Completion date31/05/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit12 Years
SexAll
Target sample size at registration65
Key inclusion criteriaThe 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 criteriaChild:
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 enrolment01/03/2012
Date of final enrolment31/05/2013

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Reading
Reading
RG6 6AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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

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