Treatment of child anxiety disorder in the context of maternal anxiety: a randomised controlled trial | Not Recruiting
Treatment of child anxiety disorder in the context of maternal anxiety: a randomised controlled trial
The MaCh Trial
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Mental and behavioural disorders
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN19762288
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • In an RCT for child anxiety occurring in the context of maternal anxiety: 1. Is the impact of Child Cognitive Behaviour Therapy (CCBT) enhanced by first providing CBT to the mother for her own anxiety? 2. Is the impact of CCBT enhanced by the addition of therapeutic measures designed to improve the quality of the mother-child relationship? Secondary questions: 3. Is sustained improvement in child anxiety significantly associated with a reduction in maternal anxiety? 4. Is sustained improvement in child anxiety significantly associated with improvements in maternal modelling, encouragement, over-controlling/over-protective behaviour, and associated cognitions? On 21/03/2012 the overall trial end date was changed from 31/01/2011 to 01/12/2012.
Phase
Sorry, this information is not available
Study Design
Randomised controlled trial
Study Type
Interventional
Intervention

Current interventions as of 24/04/2012 Arm 1: CCBT + MCBT + MCI control Arm 2: CCBT + MCBT control + MCI Arm 3: CCBT + MCBT control + MCI control MCBT: CBT for maternal anxiety disorder This will consist of an eight-session (one hour each) intervention for mothers delivered by a clinical psychologist (or equivalent) over eight weeks. Sessions will take place in the participants' local Child and Adolescent Mental Health Service (CAMHS), within their home, or at the University of Reading. The programme will follow a manualised transdiagnostic treatment for adult anxiety disorders. MCBT control: Supportive Counselling This will consist of either two or eight sessions (one hour each) of supportive counselling, delivered by a clinical psychologist (or equivalent) over eight weeks. Sessions will take place in the participants' local CAMHS, within their home, or at the University of Reading. The supportive counselling programme will follow a manualised treatment. CCBT: CBT for child anxiety disorder All participating children will receive an eight-session (one hour each) intervention based on the Cool Kids programme, delivered by a clinical psychologist (or equivalent) over eight weeks. Sessions will take place in the participants' local CAMHS, within their home, or at the University of Reading. MCI : Treatment of mother-child interaction This intervention consists of 10 sessions; eight with the mother alone and two with the mother and child together. This is a novel intervention which specifically targets anxiogenic features of the mother-child relationship. Specifically it aims to enhance maternal cognitions associated with child competence, reduce maternal overcontrol/overprotection, and enhance maternal warmth and encouragement. This is achieved through a combination of specific materials from existing family interventions for childhood anxiety and video-feedback techniques developed and piloted by the trial investigators. This intervention is provided by a clinical psychologist (or equivalent) in parallel with the CCBT sessions. Sessions will generally take place in the participants' local CAMHS, within their home, or at the University of Reading. The two mother and child sessions will be conducted within the laboratory at the University of Reading, as these involve the mother and child completing structured tasks which are video-recorded for feedback purposes. MCI control: Family Lifestyle Management This will consist of four sessions, two with the mother alone and two with the mother and child together. These sessions will focus on promoting a healthy lifestyle with a focus on family diet and exercise, based on existing packages applied within school settings. This intervention is provided by a clinical psychologist (or equivalent) in parallel with the CCBT sessions. Sessions will generally take place in the participants' local CAMHS, within their home, or at the University of Reading. For all treatment conditions, therapists will routinely rate the extent to which participants adhere to the intervention (e.g. completion of in-session and homework exercises, session attendance). Previous interventions Arm 1: CCBT + MCBT (CBT for maternal anxiety disorder) + MCI control (Treatment of mother-child interaction) Arm 2: CCBT + MCBT control + MCI Arm 3: CCBT + MCBT control + MCI control MCBT control: This will consist of an eight-session (one hour each) intervention for mothers delivered by a clinical psychologist (or equivalent) over eight weeks. Sessions will take place in the participants' local Child and Adolescent Mental Health Service (CAMHS), within their home, or at the University of Reading. The programme will follow a manualised transdiagnostic treatment for adult anxiety disorders. MCBT control: Supportive Counselling. This will consist of either two or eight sessions (one hour each) of supportive counselling, delivered by a clinical psychologist (or equivalent) over eight weeks. Sessions will take place in the participants' local CAMHS, within their home, or at the University of Reading. The supportive counselling programme will follow a manualised treatment. CCBT: All participating children will receive an eight-session (one hour each) intervention based on the Cool Kids programme, delivered by a clinical psychologist (or equivalent) over eight weeks. Sessions will take place in the participants' local CAMHS, within their home, or at the University of Reading. MCI: This intervention consists of 10 sessions; eight with the mother alone and two with the mother and child together. This is a novel intervention which specifically targets anxiogenic features of the mother-child relationship. Specifically it aims to enhance maternal cognitions associated with child competence, reduce maternal overcontrol/overprotection, and enhance maternal warmth and encouragement. This is achieved through a combination of specific materials from existing family interventions for childhood anxiety and video-feedback techniques developed and piloted by the trial investigators. This intervention is provided by a clinical psychologist (or equivalent) in parallel with the CCBT sessions. Sessions will generally take place in the participants' local CAMHS, within their home, or at the University of Reading. The two mother and child sessions will be conducted within the laboratory at the University of Reading, as these involve the mother and child completing structured tasks which are video-recorded for feedback purposes. MCI control: Family Lifestyle Management This will consist of four sessions, two with the mother alone and two with the mother and child together. These sessions will focus on promoting a healthy lifestyle with a focus on family diet and exercise, based on existing packages applied within school settings. This intervention is provided by a clinical psychologist (or equivalent) in parallel with the CCBT sessions. Sessions will generally take place in the participants' local CAMHS, within their home, or at the University of Reading. For all treatment conditions, therapists will routinely rate the extent to which participants adhere to the intervention (e.g. completion of in-session and homework exercises, session attendance).

Intervention Type
Behavioural
Primary Outcome Measures
  • The primary outcome is child anxiety (assessed both categorically [i.e. diagnosis] and continuously
  • [i.e. symptoms]). Diagnostic status will be assessed by the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV: C/P administered to both the mother and child. Assessors will be blind to treatment condition. Assessors' beliefs about treatment condition will be formally assessed. Child anxiety symptoms will be assessed using questionnaires (Spence Children's Anxiety Scale [SCAS]) administered to the child, the mother and the child's teacher. These measures will be administered post-treatment, and at 6 and 12 month follow-up assessments.
Secondary Outcome Measures
  • 1. Maternal anxiety, assessed categorically using the ADIS (DSM-IV) post-treatment, and at 6- and 12-month follow-up assessments
  • 2. Maternal anxiety, assessed continuously using the following questionnaires post-treatment, and at 6- and 12-month follow-up assessments:
  • 2.1. Depression Anxiety and Stress Scales (DASS)
  • 2.2. Penn State Worry Questionnaire (PSWQ)
  • 2.3. Social Interaction Anxiety Scale (SIAS)
  • 2.4. Social Phobia Scale (SPS)
  • 3. Maternal interactive behaviours will be assessed by filming the mother assisting the child perform an anxiety provoking task and applying standardised ratings of anxiogenic behaviours (i.e. modelling, lack of encouragement, overcontrol/overprotection). Interactive behaviours will be coded by independent, trained, reliable raters. Coders will be blind to the purpose and conditions of the trial. Maternal cognitions will be assessed by a standardised interview. These measures will be conducted at the post-treatment assessment.
Publication(s)
Sorry, this information is not available
Result Reports
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Gender
Both
Age Range
Mixed
Who Can Participate
Patient
Number of Participants
210
Participant Inclusion Criteria
  • Current inclusion criteria as of 21/03/2012
  • 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, co-morbid with one of the previous disorders
  • 3. Absence of significant physical or intellectual impairment (including autistic spectrum disorders)
  • Mother:
  • 1. Primary carer
  • 2. Current maternal DSM-IV anxiety disorder
  • 3. Absence of severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence)
  • For both the mother and child:
  • Absence of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least one month with agreement to maintain that dose throughout the study)
  • Previous inclusion criteria
  • Child:
  • 1. Aged 7 to 12 years
  • 2. Primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) generalised anxiety disorder, social phobia, or separation anxiety disorder
  • 3. Absence of significant physical or intellectual impairment (including autistic spectrum disorders)
  • Mother:
  • 1. Primary carer
  • 2. Current maternal DSM-IV anxiety disorder
  • 3. Absence of severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence)
  • For both the mother and child:
  • Absence of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least one month with agreement to maintain that dose throughout the study)
Participant Exclusion Criteria
  • Child:
  • 1. Aged less than 7 or over 12 years
  • 2. No primary diagnosis of DSM-IV generalised anxiety disorder, social phobia, or separation anxiety disorder
  • 3. Presence of significant physical or intellectual impairment (including autistic spectrum disorders)
  • Mother:
  • 1. Is not primary carer
  • 2. Absence of current maternal DSM-IV anxiety disorder
  • 3. Presence of severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence)
  • For both the mother and child:
  • Presence of psychotropic medication at a stable dose for less than one month
Trial Location(s)
Reading
RG6 6AL
Trial Contact(s)
Primary Trial Contact
Prof Peter Cooper
p.j.cooper@reading.ac.uk
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Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Treatment of child anxiety disorder in the context of maternal anxiety: a randomised controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Medical Research Council (UK)
  • Berkshire Healthcare NHS Trust (UK)
Other Study ID Numbers
G0601020
Sponsor(s)
University of Reading (UK)
Key Dates

Recruitment Start Date

01 Jan 2008

Recruitment End Date

01 May 2011

Trial Start Date

01 Jan 2008

Trial End Date

01 Dec 2012

Date Assigned

04 Jan 2008

Last Updated

04 Jun 2015