Condition category
Mental and Behavioural Disorders
Date applied
12/04/2005
Date assigned
30/06/2005
Last edited
23/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.psych-sci.manchester.ac.uk/pacmantrial/

Contact information

Type

Scientific

Primary contact

Dr Sam Cartwright-Hatton

ORCID ID

Contact details

School of Psychological Sciences
Zochonis Building
Brunswick St
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2576
sam.cartwright-hatton@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G108/604

Study information

Scientific title

Acronym

PACMAN trial (Parenting for Anxious Children - Manchester)

Study hypothesis

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Taking part information is found in http://www.psych-sci.manchester.ac.uk/pacmantrial/takingpart/

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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’.

Secondary outcome measures

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.

Overall trial start date

31/03/2005

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

72. Added 07/09/09: referrals are no longer accepted.

Participant 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.

Recruitment start date

31/03/2005

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychological Sciences
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
Anne-Marie.Brennan@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) G108/604

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21334564

Publication citations

  1. Results

    Cartwright-Hatton S, McNally D, Field AP, Rust S, Laskey B, Dixon C, Gallagher B, Harrington R, Miller C, Pemberton K, Symes W, White C, Woodham A, A new parenting-based group intervention for young anxious children: results of a randomized controlled trial., J Am Acad Child Adolesc Psychiatry, 2011, 50, 3, 242-251.e6, doi: 10.1016/j.jaac.2010.12.015.

Additional files

Editorial Notes