Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sinead McGilloway
ORCID ID
Contact details
Mental Health and Social Research Unit
Department of Psychology
National University of Ireland
Maynooth
N/A
Ireland
+353 (0)1 708 4765
Sinead.McGilloway@nuim.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An evaluation of the effectiveness of the Incredible Years BASIC parent training and small group DINA programmes for children with symptoms of attention deficit hyperactivity disorder (ADHD)
Acronym
Study hypothesis
The Incredible Years BASIC parent training and small group DINA programmes will affect (short-term) emotional and behavioural outcomes for children with symptoms of attention deficit hyperactivity disorder (ADHD).
Ethics approval
1. NUI Maynooth Social Research Ethics Sub-Committee approved in November 2010
2. Health Service Executive Linn Dara and Beechpark Ethics Committee approved in January 2011
Study design
Small-scale multicentre community based parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
http://iyirelandstudy.ie/faq-s.html
Condition
Hyperkinetic disorders
Intervention
1. Incredible Years DINA programme: 18 - 22 week small-group (6 children) weekly training programme
2. Incredible Years BASIC parent training programme: 18 - 20 week programme which involves weekly 2 - 2.5 hour group sessions
Following baseline assessments, parents and children will be randomly allocated on a 2:1 ratio to an intervention or waiting-list control group.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Werry-Weiss Peters Activity Rating Scale
2. Conners Parent Rating scale - Revised short form
All measures will be administered at baseline, February 2011 (prior to randomisation) and approximately 6 months later, August 2011.
Secondary outcome measures
1. Arnold et al. Parenting scale
2. Parent Stress Index
3. Strengths and Difficulties Questionnaire
All measures will be administered at baseline, February 2011 (prior to randomisation) and approximately 6 months later, August 2011.
Overall trial start date
01/02/2011
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The parent must have a child aged 3 - 6 years, either sex
2. The parent must want the training
3. The parent must agree to participate in both the research and the BASIC parent training
4. The identified child must score above the cut-off on a standardised ADHD screening measures (see below)
5. The parent must be willing to be placed on a waiting list for the parent training for approximately 6 months
6. The parent and child must not have previously taken part in any Incredible Years training programme
7. The child must not be taking ADHD-related medication for the duration of the trial
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
72 parents and 18 children
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/02/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Ireland
Trial participating centre
Mental Health and Social Research Unit
Maynooth
N/A
Ireland
Sponsor information
Organisation
Archways Ltd (Ireland)
Sponsor details
Unit 2B
Nangor Road Business Park
Nangor Road
Clondalkin
Dublin
D12
Ireland
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Archways Ltd (Ireland) [Atlantic Philanthropies and Dormant Accounts Fund]
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