Condition category
Mental and Behavioural Disorders
Date applied
22/01/2011
Date assigned
21/04/2011
Last edited
21/04/2011
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.iyirelandstudy.ie/

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 measures

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

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

http://www.archways.ie

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes