Anxiety in young children: A randomised controlled trial of a new cognitive-behaviourally based parenting intervention

ISRCTN	ISRCTN12166762
DOI	https://doi.org/10.1186/ISRCTN12166762
Protocol serial number	G108/604
Sponsor	University of Manchester (UK)
Funder	Medical Research Council (MRC) (UK) G108/604

Submission date: 12/04/2005
Registration date: 30/06/2005
Last edited: 23/02/2011

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

Dr Sam Cartwright-Hatton
Scientific

School of Psychological Sciences
Zochonis Building
Brunswick St
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 275 2576
Email	sam.cartwright-hatton@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PACMAN trial (Parenting for Anxious Children - Manchester)
Study objectives	Participants randomised to receive a new cognitive-behaviourally based parenting intervention will exhibit greater reductions in anxiety disorders and internalising symptoms than: a. Those who have been in a waiting list control group, after the end of the intervention period (10 weeks) b. Those who were on the waiting list, and subsequently received treatment as usual at 12 months follow-up
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Anxiety Disorders
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	10 Years
Sex	All
Target sample size at registration	72
Key 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.
Key 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.
Date of first enrolment	31/03/2005
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Psychological Sciences

Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes