Condition category
Mental and Behavioural Disorders
Date applied
12/10/2009
Date assigned
15/12/2009
Last edited
18/07/2016
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.dartington.org.uk

Contact information

Type

Scientific

Primary contact

Dr Vashti Berry

ORCID ID

Contact details

The Social Research Unit
Lower Hood Barn
Dartington
TQ9 6AB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

L680 TA-01631-01 RVPOG AOO

Study information

Scientific title

A randomised controlled trial of the Triple P Parent Programme with parents of children at risk of developing conduct disorder in six clusters across Birmingham City

Acronym

Study hypothesis

1. There will be an improvement in parenting competencies following parent training
2. Children whose parents received parent training will show a reduced problem behaviour and hyperactivity, and improved social competence
3. The programme will offer value for money and net benefit to the Council

Ethics approval

Warren House Group Ethics Committee, 05/03/2009, ref: WHG 2009-1

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Conduct disorder (CD)

Intervention

The 8-week Triple P Parent Programme will be delivered in Schools/Children Centres as an intervention to parents of children already displaying problematic behaviour in order to reduce the likelihood of children developing conduct disorder. The waiting list control group will be offered the intervention after the final follow up, 12 months after baseline.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total child difficulties, measured using the parent completed Strengths and Difficulties Questionnaire (SDQ). The subscales of conduct, peer relationships and hyperactivity problems, social competence, and the impact supplement, which assesses the impact problem behaviour can have in other areas of life, will also be analysed. The clinical cut-off is 17 for total difficulties - the higher the score the worse the problems. This measure will be administered at baseline, and the 6- and 12-month follow-ups.

Secondary outcome measures

Parent report at baseline, 6- and 12-month follow-ups:
1. 36-item Eyberg Child Behaviour Inventory (ECBI), to assess child problem behaviours on the index child and sibling closest in age. Each behaviour is rated on two scales:
1.1. 7-point Intensity Scale, measures how often the behaviour is perceived to occur, ranging in response intensity from 1 (never) to 7 (always)
1.2. Yes-No Problem Scale, identifies whether the behaviour is currently seen as a problem for the parent
2. Demographics Questionnaire administered at baseline to assess background family characteristics; a follow-up version will be administered at both follow-ups to establish any factors that may impact on the results
3. Parenting Scale, to assess parenting competencies. There is no cut-off but the higher the score on the 7-point Likert Scale the less competent, or skilled, the parent.
4. Adapted Service Use Questionnaire, to establish amount and type of health, social and education services accessed by the main caretaker and index child. This information will be used to calculate cost effectiveness and future cost benefits.

Overall trial start date

01/11/2009

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of a child (either sex) aged 5 - 11 years
2. Living within one of the designated six clusters
3. Child scoring above the clinical cut-off of 17 for total difficulties on the Strengths and Difficulties Questionnaire (SDQ)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

288 (144: intervention; 144 waiting list control)

Participant exclusion criteria

Parents will be excluded if their child was the wrong age or scored below the cut off on the SDQ.

Recruitment start date

01/11/2009

Recruitment end date

28/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Social Research Unit
Dartington
TQ9 6AB
United Kingdom

Sponsor information

Organisation

Birmingham City Council (UK)

Sponsor details

c/o Cheryl Hopkins
Service Director - Strategy & Commissioning
CYP&F Directorate
Room 183
Council House Extension
Margaret Street
Birmingham
B3 3BU
United Kingdom

Sponsor type

Government

Website

http://www.birmingham.gov.uk/

Funders

Funder type

Government

Funder name

Birmingham County Council (UK) (ref: L680 TA-01631-01 RVPOG AOO)

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

Publication citations

Additional files

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.