Promoting tolerance of children’s feelings | Not Recruiting
Promoting tolerance of children’s f... | Not Recruiting
Promoting tolerance of children’s feelings

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Medical Conditions
  • Anxiety
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN77196667

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Summary
Not provided at time of registration
Research Details
  • 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.
Phase
Sorry, this information is not available
Study Design
Randomised interventional treatment
Study Type
Interventional
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
Primary Outcome Measures
    Primary indicator of recovery measured post treatment
Secondary Outcome Measures
    Change in parental interactive behaviours measured at the end of study
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Child
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 65; UK Sample Size: 65
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 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).
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Earley
RG6 6AL
Trial Contact(s)
Primary Trial Contact
Dr Adela Apetroaia
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Promoting tolerance of children’s feelings: a randomised controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Medical Research Council
Other Study ID Numbers
11832
Sponsor(s)
University of Reading (UK)
Key Dates

Recruitment Start Date

01 Mar 2012

Recruitment End Date

31 May 2013

Trial Start Date

01 Mar 2012

Trial End Date

31 May 2013

Date added to source

22 Mar 2012

Date updated in source

25 Feb 2016