Condition category
Mental and Behavioural Disorders
Date applied
18/04/2016
Date assigned
18/04/2016
Last edited
18/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a common childhood disorder in which the sufferer struggles with attention, impulsivness and hyperactivity. Almost all treatments for ADHD have been adjusted for treating children or adults, and little research has been done to evaluate their effectiveness in adolescents. Adolescence is a time involving rapid physical, mental and social development takes place, which can lead to feelings of inner turmoil, emotional instability and negative mood. Adolescents with ADHD have a high risk of experiencing problems in development in these areas because of issues with being able to manage disruptive emotions and impulses. PowerCoaching is an ADHD treatment specifically designed for adolescents. The aim of this study is to evaluate the effectiveness of this treatment.

Who can participate?
Adolescents with ADHD between the ages of 12 and 18 years old.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive PowerCoaching immediately. This involves sessions at the participant's home every week for 18 weeks. The sessions last for about an hour and involve discussions about a range of topics and the teaching of stratagies to help cope with ADHD related problems. Those in the second group receive treatment as usual for the 18 weeks of the study. Participants in both groups complete a number of questionnaires at the start of the study and then again after 18 weeks. After participants in both groups are assessed, participants in this group are able to take part in the PowerCoaching, but no further measurements are taken.

What are the possible benefits and risks of participating?
The coaching program may benefit participants in helping them to cope with daily problems related to ADHD and improve their quality of life. There are no notable risks involved with taking part in the study.

Where is the study run from?
Yulius Academie (Netherlands)

When is the study starting and how long is it expected to run for?
February 2014 to December 2016

Who is funding the study?
Yulius (Netherlands)

Who is the main contact?
S. Kapiteijn, MSc.
s.kapiteijn@yulius.nl

Trial website

https://yuliusacademie.nl/powercoaching

Contact information

Type

Scientific

Primary contact

Dr Athanasios Maras

ORCID ID

Contact details

Yulius Academie
Dennenhout 1
Barendrecht
2994GC
Netherlands
+31 88 403 6950
a.maras@yulius.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An RCT pilot of treatment as usual compared to PowerCoaching: An multiple domain CBT coaching program for adolescents between 12 and 18 years old with Attention Deficit Hyperactivity Disorder

Acronym

Study hypothesis

1. Adolescents' quality of life is enhanced after participating in PowerCoaching compared to a control condition
2. Adolescents in the intervention condition will show more self-efficiency and selfregulating behavior and less psychosocial problems than adolescents in the control condition

Ethics approval

Medisch Ethische Toetsings Commissie TWOR, 06/03/2014, ref: MEC-2013_50, general reference number: NL47364.101.13

Study design

18-week immediate versus delayed intervention randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Attention deficit hyperacitivty disorder (ADHD) and problems in daily functioning

Intervention

Adolescents are randomized to one of two groups:

Immediate treatment group: Participants receive the PowerCoaching for a total of 18 weeks. Sessions are given once a week at the participant's home, lasting for 45 to 60 minutes, and involve the discussion of different themes (i.e. psycho-education, planning and organisation, school and study, self-image, emotion regulation, relations, risk and control and lifestyle). During the sessions, participants will learn new strategies to cope with ADHD related problems.

Delayed treatment group: For the 18 week duration of the study, participants continue as usual. Following collection of the final outcomes, the treatment is made available from week 19 to week 37.

Participants in both groups complete outcome measurements at baseline and 18 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Quality of life is measured using “Weiss Functional Impairment Rating Scale (WFRIS) excluding the subscale ‘work’ at baseline and 18 weeks.

Secondary outcome measures

1. Self-efficiency measured using a self-constructed questionnaire at baseline and 18 weeks
2. selfregulating behavior measured using the Behavior Rating Iventory Executive Functions's subscales emotion regulation, planning and organizing, and organization of materials at baseline and 18 weeks
3. Psychosocial problems measured using the Strengths and Difficulties Questionnaire at baseline and 18 weeks

Overall trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 12 to 18 years
2. An official Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV ADHD diagnosis (all subtypes). The diagnosis must have been previously set by a child and adoelscent psychiatrist, Healthcare psychologist, clinical psychologist or paediatrician specialized in social paediatrics. Adolescents with common diagnosed comorbid disorders (i.e., dyslexia, oppositional defiant disorder) can participate in the study as long as ADHD is the main disorder.
3. Stable ADHD treatment, both pharmacological and psychological
4. Minimum total intelligence quotiënt (TIQ) score must be greater than or equal to 85
5. Fluent in Dutch
6. Provision of written informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Addiction to drugs or alcohol
2. Severe psychotic disorder
3. Another acute Axis-I disorder

Recruitment start date

12/02/2015

Recruitment end date

01/03/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

Yulius Academie
Dennenhout 1
Barendrecht
2994 GC
Netherlands

Sponsor information

Organisation

Maasstad Hospital Rotterdam (Maasstadziekenhuis Rotterdam)

Sponsor details

Maasstadweg 21
Rotterdam
3007AC
Netherlands

Sponsor type

Hospital/treatment centre

Website

https://www.maasstadziekenhuis.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Yulius

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

01/05/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes