Treatment of child anxiety disorder in the context of maternal anxiety

ISRCTN	ISRCTN19762288
DOI	https://doi.org/10.1186/ISRCTN19762288
Secondary identifying numbers	G0601020

Submission date: 06/06/2007
Registration date: 04/01/2008
Last edited: 19/02/2016

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

Prof Peter Cooper
Scientific

School of Psychology
University of Reading
Whiteknights
Berkshire
Reading
RG6 6AL
United Kingdom

Email	p.j.cooper@reading.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Treatment of child anxiety disorder in the context of maternal anxiety: a randomised controlled trial
Study acronym	MaCh
Study objectives	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?
Ethics approval(s)	Berkshire Local Research Ethics Committee, 13/11/2007, ref: 07/H0505/156
Health condition(s) or problem(s) studied	Mental and behavioural disorders
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 measure	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.
Overall study start date	01/01/2008
Completion date	01/12/2012

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	210
Key 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)
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	01/05/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Reading

Reading
RG6 6AL
United Kingdom

Sponsor information

University of Reading (UK)
University/education

Research & Enterprise Services
University of Reading
Berkshire
Reading
RG6 6AL
England
United Kingdom

Email	m.j.proven@reading.ac.uk
"ROR"	https://ror.org/05v62cm79

Funders

Funder type

Government

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Berkshire Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2015		Yes	No

Editorial Notes

19/02/2016: Publication reference added.
On 21/03/2012 the overall trial end date was changed from 31/01/2011 to 01/12/2012.