Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list