See page 9Primary Objective:The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See page 11 and 12
The primary outcome measure for academic activity consists of measures for
academic productivity (effort and engagement) and academic ability:
1. Academic productivity will be assessed by means of observation (the amount
of on-task behaviour) by a trained observer according to standardised rating
forms. In addition, percentage of completed assignments for the tests for
mathematics and spelling (see below) will be calculated as a measure of
productivity.
2. Academic ability will be assessed with a range of tests witch excellent
psychometric properties. As children with ADHD particularly experience problems
with mathematics, reading and spelling, these academic skills will be the focus
of our assessment. For reading ability technical reading, syntactic technical
reading and syntactical reading of stories are separately assessed.
Three putative mediating variables will be measured:
3. ADHD behaviours. We will use a set of well-established behavioural rating
scales to assess day-to-day behavioural effects of MPH on the child including
the Child Behavior Checklist (CBC) and Teacher Rating Form(TRF) (Achenbach &
Edelbrock, 1981), the VvGK (Oosterlaan et al., 2000), the ADHD rating-scale
(DuPaul, 2007) and the Strengths and Weakness of ADHD-symptoms and Normal
Behavior rating scale (SWAN; Hay, Bennett, Levy, Sergeant, & Swanson, 2007;
Swanson et al., 2005). Both parents and teachers are required to fill out these
rating scales measuring core ADHD and oppositional defiant (ODD) and conduct
disorder (CD) symptoms. In the interest of the cross-over design, adapted
versions are used that are suitable for repeated administration. As children
with ADHD are often hyperactive en therefore have an above-average mobility
actigraphy will be used to objectively measure mobility and sleep-wake rhythm
of children during the experimental conditions. Actigraphy is sensitive to the
effects of MPH (Boonstra et al., 2007) and provides additional information to
behavioural rating scales (Uebel et al., 2010).
4. Cognitive deficits. Cognitive performance is assessed by a measure of
estimated total IQ, measures of executive functioning including inhibitory
control, verbal and visual working memory, and attention (core executive
functioning deficits, see Willcutt et al., 2005), sensory integration and
measures of learning ability. Total estimated time for cognitive
neuropsychological tests is 60 minutes.
5. Motivational deficits. The third level of assessment concerns motivational
deficits. Motivational deficits are assessed with measures of delay aversion
and reward sensitivity, intrinsic motivation and extrinsic motivation. Delay
aversion and extrinsic motivation are assessed with neuropsychological tasks.
For intrinsic motivation, rating scales are filled out by the child, parent and
teacher. Total estimated time for the motivational measurements is 30,
including time necessary for the questionnaires.
Secondary outcome
not applicable
Background summary
See page 6
ADHD is a chronical developmental disorder. On average, one child out of every
two elementary school classes is diagnosed with ADHD. Most of these children
have comorbid learning problems or suffer from educational underachievement.
Methylphenidate (MPH) is the most commonly prescribed treatment for ADHD.
Research has proven the clinical effectivity of MPH for symptom reduction and
improved cognition. The effects of MPH on academic activity are less well
documented and nothing is currently known about processes mediating these
effects. Given de commoness of learning problem in children with ADHD it is
important to acquire more knowledge about the effects of MPH on academic
activity. Prior research has shown that MPH can reduce ADHD behavioral symptoms
and cognitive impairments (MTA study, 1999). No differences were found between
short-acting and long-acting MPH (Schachar et al., 2008; Swanson et al., 2004)
but the number of studies is limited. Even though MPH acts upon the dopamine
networks little is known about the effects of MPH on motivational problems in
children with ADHD.
Study objective
See page 9
Primary Objective:
The primary objective of this study is to explore the relationship between MPH
and academic activity and the mediating roles of ADHD behaviours, cognitive
deficits and motivational deficits in this relationship. Therefore, the direct
effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits
are taken into account. In particular, evidence on the effects of MPH on
motivational deficits in ADHD is scarce. It is hypothesized that treatment with
MPH results in increased academic activity as compared to placebo control. If
MPH improves academic activity, comparisons with the control group will be made
to see if academic activity in children with ADHD normalises when treated with
MPH.
Secondary Objectives:
Secondary objectives are to explore the relation between academic effort and
engagement and academic ability, resulting in a clearer description of the
construct of academic activity which is a frequently used outcome variable in
many clinical studies. Furthermore, the relation between behaviour, cognition,
motivation and academic activity will be studied in children between 8-13 years
old. A comparison between children with ADHD and healthy controls will be made
to investigate whether the relationship between these variables differs between
these groups.
Study design
The study design is a randomised placebo-controlled cross-over design. Each
condition (Equasym versus placebo) lasts one week.
Intervention
See page 10 and 11
In the placebo-condition the participants will take a placebo-capsule every
morning for one week. In the medication-condition participants will take a
capsule with Equasym XL every morning for one week. Testing takes place at the
last day of both week. Before and between the test weeks a washout period (2-4)
is scheduled. When the participants regular medication consists of short-acting
MPH, this dose will be converted to the optimal dose for long-acting MPH (see
Banachewski et al., 2002). The optimal clinical dose has been determined at the
time of medication prescription, either with a double-blind placebo-controlled
trial or with by slowly increasing the dose until an optimal behavioral effect
with minimal side effects is reached.
Study burden and risks
No risks associated with participation to our study are known. Participants
receive their regular dose of medication or a converted dose of MPH in a
different formulation. During the placebo condition the participants receive no
medication. For this study every participant will be tested twice (at the end
of each condition) for 90-120 minutes. To minimize inconvenience, testing takes
place at the primary school of the participant. Therefore, no extra time
invested needs to be made by the parents and no additional traveling is
required. In addition, short questionnaires will be filled in by the parents
and teacher of the participant and the participant will be observed in the
classroom for a short time period (8 minuten).
In general, experience learns that most children enjoy the computerized tests
that look like computer games. To assure that testing does not interfere with
the school program, a suitable testing time is chosen in consultation with the
teacher.
Because many children with ADHD between 8-13 years of age experience problems
at school and many of these children are treated with MPH it is important for
these children and their parents to know more about the the effects of MPH on
academic activity. Furthermore, additional knowledge on the effects of MPH on
behavioral, cognitive and motivational deficits in ADHD are important, also to
improve treatment.
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients: Children with ADHD will be included if they (1) are diagnosed with ADHD, (2) are currently treated with methylphenidate to reduce ADHD symptoms, (3) are aged between 8 and 13, (4) have an IQ > 70, and (5) the children and their parents have sufficient knowledge of the Dutch language;Control group: Children will be included if they are (1) aged between 8-13 years, and (2) attend regular primary school
Exclusion criteria
The following exclusion criteria will be applied for the patient group: (1) medication other than methylphenidate, (2) psychiatric disorder(s) other than ADHD and oppositional defiant disorder (ODD) conduct disorder (CD), anxiety disorder and learning disorder and, (3) neurological impairments.;For the control group children will be excluded if they have psychiatric or neurological problems.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000492-17-NL |
| CCMO | NL39440.029.12 |