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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN12166762 |
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Date of registration:
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30/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anxiety in young children: A randomised controlled trial of a new cognitive-behaviourally based parenting intervention
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Scientific title:
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Date of first enrolment:
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31/03/2005 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12166762 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sam
Cartwright-Hatton |
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Address:
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School of Psychological Sciences
Zochonis Building
Brunswick St
M13 9PL
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 275 2576 |
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Email:
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sam.cartwright-hatton@manchester.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Families of anxious children aged under 10 years. Patients will be included in the trial if they score at or above the suggested clinical cut-off for an internalising disorder on the child behaviour checklist (the primary outcome measure). However, to ensure that all participants are of clinical severity, they must also have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of an anxiety disorder, assessed by the Anxiety Disorders Interview Schedule for Children (not including specific phobia, obsessive compulsive disorder, post-traumatic stress disorder/acute stress disorder, anxiety due to a general medical condition, or substance induced anxiety disorder). Participants will not be excluded on the grounds of other comorbid conditions.
Exclusion criteria: Parents or children with moderate to severe learning disabilities will not be included in the study. Children whose parents do not have adequate English to benefit from the group format of the intervention will not be included.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety Disorders
Mental and Behavioural Disorders
Anxiety disorders
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Intervention(s)
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Experimental intervention: 10 week course of 2-h group sessions for parents. Content is cognitive-behaviourally based parenting advice, focussing on gentle and consistent discipline, relationship building, and techniques to manage worry and fear.
Control intervention: 10 weeks wait list, followed by treatment as usual.
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Primary Outcome(s)
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The primary outcome point is after 10 weeks participation in the trial, comparing those who have received the new intervention, and those who have remained on a waiting list. The primary outcome measure will be parent report of ?internalising symptoms? on the ?Child Behavior Checklist?.
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Secondary Outcome(s)
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The secondary outcome point is after 12 months in the trial where those who received the new intervention, and those who remained on a waiting list for at least 10 weeks before receiving ?treatment as usual? will be compared. The secondary outcome measures are teacher report of ?internalising symptoms? on the ?Child Behavior Checklist ? teacher report form?; and DSM-IV Anxiety Disorder diagnosis.
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK) G108/604
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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