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| Treatment of child anxiety disorder in the context of maternal anxiety: A randomised controlled trial |
| Source of record | UK Trials |
| ISRCTN | ISRCTN19762288 |
| Date ISRCTN assigned | 04/01/2008 |
| Local reference number(s) | G0601020 |
| Public title | Treatment of child anxiety disorder in the context of maternal anxiety: A randomised controlled trial |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Mental and behavioural disorders |
| Study hypothesis | 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? |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Approved by the Berkshire Local Research Ethics Committee on the 13th November 2007 (ref: 07/H0505/156) |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material | Not yet available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/01/2011 |
| Status of trial | Ongoing |
| Target number of participants | 210 |
| 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). |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | 1. Medical Research Council (UK) 2. Berkshire Healthcare NHS Trust (UK) |
| Sponsor name | University of Reading (UK) |
| Sponsor details | Research & Enterprise Services University of Reading Berkshire Reading United Kingdom RG6 6AL |
| Sponsor email | m.j.proven@rdg.ac.uk |
| Contact name | Prof Peter Cooper |
| Contact details | School of Psychology University of Reading Whiteknights Berkshire Reading United Kingdom RG6 6AL |
| Contact email | p.j.cooper@rdg.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN19762288 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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