Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000387325
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
16/03/2017
Date last updated
16/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing Effective Strategies for Reducing Child Problem Behavior Among Children Diagnosed with Attention Deficit Hyperactivity Disorder (ADHD): An Evaluation of the 1-2-3 Magic Parenting Program
Scientific title
Testing Effective Strategies for Reducing Child Problem Behavior Among Children Diagnosed with ADHD: An Evaluation of the 1-2-3 Magic Parenting Program
Secondary ID [1] 291389 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood ADHD 302412 0
Condition category
Condition code
Mental Health 301983 301983 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural parent training: 1-2-3 Magic: Effective Discipline for Children 2-12 Program.
Parents attended three intervention sessions over subsequent weeks (2 hours per session) and a booster session (one and a half hours) four weeks later. The three intervention sessions involved watching the 1-2-3 Magic DVD's, therapist input and group discussions. The booster session was a group discussion.

The intervention sessions coverered selected segments from the two 1-2-3 Magic DVD's, 1-2-3 Magic: Managing Difficult Behavior in Children 2-12 and More 1-2-3 Magic: Encouraging Good Behavior, Independence and Self-Esteem.

Both DVD's included explanations of the parenting training techniques and their application in various home and public settings. Both DVD’s featured role-play vignettes showing maladaptive parent-child interactions followed by vignettes demonstrating the corrective, more adaptive style of parent-child interaction. Total time viewing the DVD’s across the three intervention sessions was 163 minutes.

Summary of the components of 1-2-3 Magic program utilized in this study
Week 1 - 1-2-3 Magic DVD
Stop behavior
Part 1 - Straight thinking
Part 2 - Controlling obnoxious behavior
Part 3 - Real world applications/Frequently asked questions
Week 2 - 1-2-3 Magic DVD
Stop behavior
Part 4 - Testing and manipulation
Part 5 - Counting in action
Part 6 - Conclusion
Week 3 - More 1-2-3 Magic DVD
Start behavior
Introduction and review
Part 1 - Seven tactics for encouraging good behavior
Part 2 - Specific applications

Throughout the three intervention sessions the therapist explained and revised the salient concepts shown in the 1-2-3 Magic DVD's and answered participants' questions.

The booster session provided participants with an opportiunity to have any queries they had about the program answered. It also provided participants with an opportunity to share their experiences in implementing the 1-2-3 Magic Program. Participation in the group discussion was a free choice. Group size - maximum 29.
Intervention code [1] 297430 0
Treatment: Other
Comparator / control treatment
Waitlist-control group. The waitlist control group received the same intervention as the treatment goup (i.e., the 1-2-3 Magic Propgram) once the treatment group intervention had been completed.


Control group
Active

Outcomes
Primary outcome [1] 301399 0
Change in child disruptive behaviour - Eyberg Child Behavior Inventory (ECBI, Eyberg & Pincus, 1999), validated measure.
Timepoint [1] 301399 0
Time 1 - Baseline, prior to commencement of the intervention.
Time 2 - Post-intervention, 8 weeks post commencement of intervention.
Time 3 - 6 months follow-up, 6 months post intervention completion.
Primary outcome [2] 301400 0
Change in parenting behaviour - The Parent Stress Index (Fourth Edition) – Short Form (PSI-4-SF; Abidin, 1990), validated measure.
Timepoint [2] 301400 0
Time 1 - Baseline, prior to commencement of the intervention.
Time 2 - Post-intervention, 8 weeks post commencement of intervention.
Time 3 - 6 months follow-up, 6 months post intervention completion.
Primary outcome [3] 301401 0
Change in child ADHD behaviour - Conners 3rd Edition – Parent Short Form (Conners 3-P(S); Conners, 2008), validated measure.
Timepoint [3] 301401 0
Time 1 - Baseline, prior to commencement of the intervention.
Time 2 - Post-intervention, 8 weeks post commencement of intervention.
Time 3 - 6 months follow-up, 6 months post intervention completion.
Secondary outcome [1] 332539 0
Participant staisfaction - Therapy Attitude Inventory (TAI; Breston, Jacobs, Rayfield & Eyberg, 1999), validated measure.
Timepoint [1] 332539 0
Time 2 - Post-intervention, 8 weeks post commencement of intervention.

Eligibility
Key inclusion criteria
1. Parents of a child diagnosed with ADHD.
2. Target child required to be aged 6-12 years.
3. Target child required to have a formal diagnosis of ADHD.
4. Parent required to reside with the target child on a full-time or majority part-time basis.
5. Parent required to have current concerns about the target child's behaviour in the home environment.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. If child was not within the specified age range.
2. If the child did not have a formal diagnosis of ADHD.
3. If the caregiver was adequately managing the child's behaviour at home.
4. If the family were currently receiving treatment for the child's behaviour elsewhere.
5. If the caregiver was unable to attend the initial information session and at least two of the three designated intervention sessions.
6. If the caregiver had previously attended the 1-2-3 Magic program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using paired randomisation based on scores from screening questions.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2015
Date of last participant enrolment
Anticipated
Actual
28/07/2015
Date of last data collection
Anticipated
Actual
29/02/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295864 0
University
Name [1] 295864 0
Macquarie University
Country [1] 295864 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Psychology
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 294725 0
None
Name [1] 294725 0
Address [1] 294725 0
Country [1] 294725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297147 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 297147 0
Ethics committee country [1] 297147 0
Australia
Date submitted for ethics approval [1] 297147 0
11/04/2013
Approval date [1] 297147 0
09/05/2013
Ethics approval number [1] 297147 0
5201300287

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73130 0
Prof Richard Stevenson
Address 73130 0
Department of Psychology
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 73130 0
Australia
Phone 73130 0
+61 2 9850 8098
Fax 73130 0
+61 2 9850 8062
Email 73130 0
[email protected]
Contact person for public queries
Name 73131 0
Julie Chesterfield
Address 73131 0
C/- Professor Richard Stevenson
Department of Psychology
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 73131 0
Australia
Phone 73131 0
+61 412414114
Fax 73131 0
Email 73131 0
[email protected]
Contact person for scientific queries
Name 73132 0
Richard Stevenson
Address 73132 0
Department of Psychology
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 73132 0
Australia
Phone 73132 0
+61 2 9850 8098
Fax 73132 0
+61 2 9850 8062
Email 73132 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.