Attention Deficit Hyperactivity Disorder (ADHD)TDAHEC2NCT02560454
Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Cogmed and Presco in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Cogmed and Presco
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age ≥ 8 et ≤ 12, (2)
- ADHD diagnostic according to DSM IV or V criteria,
- score between 28 to 40 for The ADHD-RS,
- IQ-score, non-verbal reasoning (WISC-III or IV) ≥80, verbal reasoning (WISC-III or IV) ≥80,
- have internet and a computer at home,
- if methylphenidate treatments must not be changed for six months, (7) written consent by legal guardian.
Who cannot join
- Participant taking other medication than methylphenidate won't be included.
- Participant suffering from another neurological disorder than ADHD won't be included
Trial locations and contacts
1 site in 1 country.
About this study
ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations.
Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working memory training is the most commonly used and studied cognitive training program in clinical practice and research. It is clear from most studies that Cogmed training program increases working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic achievement.
Read more
In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but have been less studied.
To address these challenges, this study will follow a randomized and controlled design.
The main objective of this study is to examine the impact of cognitive training in comparison with a control waiting-list group among children with ADHD on:
- ADHD symptoms,
- cognitive functioning,
- attentional capacities
- academic achievement.
The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.
Long-term effects are examined six months after training. Participants (n=90) will be randomly assigned to the two experimental group (Cogmed or Presco) or to the control group waiting list. Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.
Read the detailed description
Attention-Deficit Hyperactivity Disorder (ADHD) is a chronic developmental disorder characterized by symptoms of inattention, impulsivity and hyperactivity that do not correspond to the child's developmental level (American Psychiatric Association, 2013). For a diagnosis to be confirmed, symptoms must be present before age 12 and must be observed in at least to two domains of functioning, such as school, work, social interactions and family life (American Psychiatric Association, 2013).
ADHD is one of the most common neurobehavioral disorder with a prevalence estimated at about 5-7% for school-age children (Psychiatric Association, 2013).
ADHD alters family, social and academic functioning as well as one's professional life.
Results from studies indicated that working memory and inhibition are often altered in ADHD in childhood and persist into adulthood.
Pharmacological treatments of ADHD mostly include psychostimulants (Amphetamine and Methylphenidate) and non-stimulants (Atomoxetine, Clonidine, Guanfacine). Stimulants and no-stimulants are effective in managing ADHD symptoms.
However, these treatments present some limitation. For instance, comorbid disorders reduce stimulants efficacy in ADHD. Further, long-term effects over the year of stimulant are not yet known. Stimulants may cause side effects on sleep, hunger and growth. That is why some parents are reluctant to let their children take stimulants.
Currently, clinical guidelines recommend non-pharmacological interventions in conjunction with medication for the treatment of ADHD.
The above-mentioned limitations to the use of medication stress the importance of developing non-pharmacological approaches. Cognitive training is one type of non-pharmacological intervention used in ADHD.
This intervention consists in improving cognitive deficits through specific exercises during intensive training session. A growing number of studies examined the impact of cognitive training in ADHD.
Cognitive training is based on principles of brain plasticity with the aim to train cognitive function and to improve cognitive deficits in ADHD. According to these authors, during training changes occur in neural connection associated to ADHD. This modification allows far transfers to cognitive function not targeted by the program, to ADHD symptoms and academic performances.
Results from a meta-analysis indicated that 68% of 25 studies examining ADHD and cognitive training focus on working memory. These authors specify that Cogmed Working Memory Training is currently the most used and studied program. Indeed, this program is available in 25 countries and used by 150 clinical practitioners (http://www.cogmed.com).
Currently, one meta-analysis including seven studies examines Cogmed Working Memory Training program effects in ADHD. Results indicated that the impact of Cogmed on cognitive functioning, ADHD symptoms and academic performance remains controversial.
Cogmed is an unifactorial program targeting working memory. In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but has been less studied.
Objectives To address these challenges, this study will follow a randomized and controlled design.
The main objective of this study is to examine the impact of cognitive training in comparison with a control group among children with ADHD on:
- ADHD symptoms,
- cognitive functioning,
- attentional capacities
- academic achievement.
The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.
Long-term effects are examined six months after training. Procedure Participants (n=90) will be randomly assigned to three groups.
- Cogmed® : working memory training (unifactorial)
- Presco® : different cognitive function are trained (multifactorial)
- Control ( waiting list) Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.
For Cogmed and Presco participants will train the same time. Before beginning the program an appointment of one hour will be organized to present the program.
Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.
Cogmed working memory training CogMed® (RoboMemo,Cognitive Medical Systems AB, Stockholm) version for children will be used in this program. Twelve exercises target verbal and visio-spatial working memory. Difficulty is adjusted depending on participant performance's The program PRESCO® (Program in Cognitive Stimulation and rehabilitation ) comprises 40 exercises targeting: verbal and visio spatial working memory, attention capacities, reasoning, executive functioning , language and mental imagery. Only exercises targeting verbal, visual spatial working memory, and attentional capacities altered in ADHD are used in this present study. Difficulty is adjusted depending on the participant performances.
- Being tested
- Cogmed, Presco
- Keywords
- Cognitive Remediation, Working Memory Training, Cognitive training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogmedBehavioural
Cogmed training working memory (unifactorial). Before beginning the program an appointment of one hour will be organized to present the program.
Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.
Cogmed working memory training CogMed RM® (RoboMemo,Cognitive Medical Systems AB, Stockholm) version for children will be used in this program. Twelve exercises target verbal and visio-spatial working memory. Difficulty is adjusted depending on participant performance's
PrescoBehavioural
Presco drive of several cognitive functions (multifactorial). Before beginning the program an appointment of one hour will be organized to present the program.
Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.
The program PRESCO® (Program in Cognitive Stimulation and rehabilitation ) comprises 40 exercises targeting: verbal and visio spatial working memory, attention capacities, reasoning, executive functioning , language and mental imagery. Only exercises targeting verbal, visual spatial working memory, and attentional capacities altered in ADHD are used in this present study. Difficulty is adjusted depending on the participant performances.
| Study group | Role | What they receive |
|---|---|---|
| Cogmed® | Experimental | Cogmed® : working memory training (unifactorial) Before beginning the program an appointment of one hour will be organized to present the program.
Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling. Receives: Behavioral: Cogmed |
| Presco® | Experimental | Presco® : different cognitive function are trained (multifactorial) Before beginning the program an appointment of one hour will be organized to present the program.
Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling. Receives: Behavioral: Presco |
| Control | No intervention | Control ( waiting list) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ADHD Rating Scale IV (ADHD RS)
Measured: 6 weeks
Secondary outcomes (4)
ADHD Scale
symptoms and psychopathology associated
Measured: 6 weeks and 6 months
TEA-Ch and Continuous Performance Test
Attentional capacities
Measured: 6 weeks and 6 months
Behavior Rating Inventory of Executive Function (BRIEF)
Cognitive functioning
Measured: 6 weeks and 6 months
Wechsler Test (WIAT-II CDN-F)
Academic achievement
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amsellem Frédérique, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560454
- Sponsor's protocol ID
- K140706
- Acronym
- TDAHEC2
- Status last verified
- Feb 2018
- First submitted
- 17 Sep 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02560454
- Acronym / sponsor ID
- TDAHEC2 / K140706
- Keywords
- Cognitive Remediation, Working Memory Training, Cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations.
Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working memory training is the most commonly used and studied cognitive training program in clinical practice and research. It is clear from most studies that Cogmed training program increases working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic achievement.
In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but have been less studied.
To address these challenges, this study will follow a randomized and controlled design.
The main objective of this study is to examine the impact of cognitive training in comparison with a control waiting-list group among children with ADHD on:
- ADHD symptoms,
- cognitive functioning,
- attentional capacities
- academic achievement.
The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.
Long-term effects are examined six months after training. Participants (n=90) will be randomly assigned to the two experimental group (Cogmed or Presco) or to the control group waiting list. Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.
Detailed description
Attention-Deficit Hyperactivity Disorder (ADHD) is a chronic developmental disorder characterized by symptoms of inattention, impulsivity and hyperactivity that do not correspond to the child's developmental level (American Psychiatric Association, 2013). For a diagnosis to be confirmed, symptoms must be present before age 12 and must be observed in at least to two domains of functioning, such as school, work, social interactions and family life (American Psychiatric Association, 2013).
ADHD is one of the most common neurobehavioral disorder with a prevalence estimated at about 5-7% for school-age children (Psychiatric Association, 2013).
ADHD alters family, social and academic functioning as well as one's professional life.
Results from studies indicated that working memory and inhibition are often altered in ADHD in childhood and persist into adulthood.
Pharmacological treatments of ADHD mostly include psychostimulants (Amphetamine and Methylphenidate) and non-stimulants (Atomoxetine, Clonidine, Guanfacine). Stimulants and no-stimulants are effective in managing ADHD symptoms.
However, these treatments present some limitation. For instance, comorbid disorders reduce stimulants efficacy in ADHD. Further, long-term effects over the year of stimulant are not yet known. Stimulants may cause side effects on sleep, hunger and growth. That is why some parents are reluctant to let their children take stimulants.
Currently, clinical guidelines recommend non-pharmacological interventions in conjunction with medication for the treatment of ADHD.
The above-mentioned limitations to the use of medication stress the importance of developing non-pharmacological approaches. Cognitive training is one type of non-pharmacological intervention used in ADHD.
This intervention consists in improving cognitive deficits through specific exercises during intensive training session. A growing number of studies examined the impact of cognitive training in ADHD.
Cognitive training is based on principles of brain plasticity with the aim to train cognitive function and to improve cognitive deficits in ADHD. According to these authors, during training changes occur in neural connection associated to ADHD. This modification allows far transfers to cognitive function not targeted by the program, to ADHD symptoms and academic performances.
Results from a meta-analysis indicated that 68% of 25 studies examining ADHD and cognitive training focus on working memory. These authors specify that Cogmed Working Memory Training is currently the most used and studied program. Indeed, this program is available in 25 countries and used by 150 clinical practitioners (http://www.cogmed.com).
Currently, one meta-analysis including seven studies examines Cogmed Working Memory Training program effects in ADHD. Results indicated that the impact of Cogmed on cognitive functioning, ADHD symptoms and academic performance remains controversial.
Cogmed is an unifactorial program targeting working memory. In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but has been less studied.
Objectives To address these challenges, this study will follow a randomized and controlled design.
The main objective of this study is to examine the impact of cognitive training in comparison with a control group among children with ADHD on:
- ADHD symptoms,
- cognitive functioning,
- attentional capacities
- academic achievement.
The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.
Long-term effects are examined six months after training. Procedure Participants (n=90) will be randomly assigned to three groups.
- Cogmed® : working memory training (unifactorial)
- Presco® : different cognitive function are trained (multifactorial)
- Control ( waiting list) Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.
For Cogmed and Presco participants will train the same time. Before beginning the program an appointment of one hour will be organized to present the program.
Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.
Cogmed working memory training CogMed® (RoboMemo,Cognitive Medical Systems AB, Stockholm) version for children will be used in this program. Twelve exercises target verbal and visio-spatial working memory. Difficulty is adjusted depending on participant performance's The program PRESCO® (Program in Cognitive Stimulation and rehabilitation ) comprises 40 exercises targeting: verbal and visio spatial working memory, attention capacities, reasoning, executive functioning , language and mental imagery. Only exercises targeting verbal, visual spatial working memory, and attentional capacities altered in ADHD are used in this present study. Difficulty is adjusted depending on the participant performances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cogmed® | Experimental | Behavioral: CogmedCogmed® : working memory training (unifactorial) Before beginning the program an appointment of one hour will be organized to present the program. Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks. A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling. |
| Presco® | Experimental | Behavioral: PrescoPresco® : different cognitive function are trained (multifactorial) Before beginning the program an appointment of one hour will be organized to present the program. Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks. A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling. |
| Control | No intervention | –Control ( waiting list) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age ≥ 8 et ≤ 12, (2)
- ADHD diagnostic according to DSM IV or V criteria,
- score between 28 to 40 for The ADHD-RS,
- IQ-score, non-verbal reasoning (WISC-III or IV) ≥80, verbal reasoning (WISC-III or IV) ≥80,
- have internet and a computer at home,
Key exclusion criteria (2 listed)
- Participant taking other medication than methylphenidate won't be included.
- Participant suffering from another neurological disorder than ADHD won't be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CogmedCogmed training working memory (unifactorial). Before beginning the program an appointment of one hour will be organized to present the program. Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks. A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling. Cogmed working memory training CogMed RM® (RoboMemo,Cognitive Medical Systems AB, Stockholm) version for children will be used in this program. Twelve exercises target verbal and visio-spatial working memory. Difficulty is adjusted depending on participant performance's | Behavioural | Cogmed® |
| PrescoPresco drive of several cognitive functions (multifactorial). Before beginning the program an appointment of one hour will be organized to present the program. Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks. A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling. The program PRESCO® (Program in Cognitive Stimulation and rehabilitation ) comprises 40 exercises targeting: verbal and visio spatial working memory, attention capacities, reasoning, executive functioning , language and mental imagery. Only exercises targeting verbal, visual spatial working memory, and attentional capacities altered in ADHD are used in this present study. Difficulty is adjusted depending on the participant performances. | Behavioural | Presco® |
Primary outcome
The ADHD Rating Scale IV (ADHD RS)
Time frame: 6 weeks
4 secondary outcomes
ADHD Scale
Time frame: 6 weeks and 6 months
TEA-Ch and Continuous Performance Test
Time frame: 6 weeks and 6 months
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 6 weeks and 6 months
Wechsler Test (WIAT-II CDN-F)
Time frame: 6 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amsellem Frédérique principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed and Presco in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ADHD Rating Scale IV (ADHD RS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.