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 |
| Secondary identifying numbers | 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
Scientific
School of Psychological Sciences
Zochonis Building
Brunswick St
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 275 2576 |
|---|---|
| sam.cartwright-hatton@manchester.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 | Taking part information is found in http://www.psych-sci.manchester.ac.uk/pacmantrial/takingpart/ |
| 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 | 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 study start date | 31/03/2005 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 72. Added 07/09/09: referrals are no longer accepted. |
| 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
- England
- United Kingdom
Study participating centre
School of Psychological Sciences
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Anne-Marie.Brennan@manchester.ac.uk | |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) G108/604
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 | 01/03/2011 | Yes | No |
