ADHDTEAMSNCT01918436
RCT, Proof of Concept Study of TEAMS (Training Executive, Attention and Motor Skills) Intervention Program
A study testing TEAMS intervention in people with ADHD and Attention Deficit Disorder With Hyperactivity, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
Background: TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological, neurocognitive intervention program targeted preschool children with ADHD developed by Professor Jeffrey Halperin, and his team from New York University. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- ADHD, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- TEAMS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Dec 2014
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 3-6, diagnosed with ADHD as primary diagnosis
Who cannot join
- Children of parents, who are not capable of cooperating in order to implement the program.
- Children living at residential institution or in an unstable environment outside the home.
- Children or parents, who do not speak/understand Danish Children, who are in medical treatment for ADHD.
- Children with significant disabilities due to comorbidity, such as autism, attachment disorder or mental retardation.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Boerne- og Ungdomspsykiatrisk afdeling, Region Sjaelland
Holbæk, 4300
Helle A. Vibholm, MSc,Ns.spec., +45 59 48 47 30, hevi@regionsjaelland.dk
Jesper Petersen, MD,Phd.
About this study
Official title: TEAMS (Training Executive, Attention, and Motor Skills): - Intervention Program for Preschoolers With ADHD (Attention Deficit Hyperactivity Disorder). A Rct. Proof-of-Concept Study.
Background:
TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological, neurocognitive intervention program targeted preschool children with ADHD developed by Professor Jeffrey Halperin, and his team from New York University. The uniqueness of this program lies in the concept, based on stimulating neurocognitive growth through focused physical activity and play (Halperin et al.; 2011, 2012, in press).
Read more
Teams hypotheses:
TEAMS is based on the notions that:
- The behavioural manifestations of ADHD are the result of deficient neural networks that affect a wide array of neurocognitive and behavioural processes which are not necessarily identical in all children with the disorder.
- Neurodevelopment is sensitive to and can be positively affected by appropriate environmental influences.
- Effective environmental stimulation will be best achieved within a social context.
- The engagement of the child in the core activities of the treatment must be intrinsically rewarding (i.e., fun) in order to facilitate compliance of the intervention.
The initial research by Halperin et al. (2012)indicated significant improvement in ADHD severity from pre- to post-treatment, which also persisted 3 months later.
Objective: The aim of this study is, through a randomized controlled trial (RCT), to validate the TEAMS treatment program in a clinical setting in Denmark.
Method: Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as primary diagnosis are offered participation in the RCT study of the TEAMS program. The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand. The intervention groups participate in eight weekly group sessions consisting of separate parent- and children's groups.
In the child group the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development.
Read the detailed description
Based on a calculation of strength:
Concurring to a statistically significant outcome the estimated cohort should be minimum 87 children. Based on Region Zealand's visitation history records the cohort is expected to be approximately 100-160 children.
Group size:
The number of participants in each treatment group depends in part on how many children have been recruited. Given the constraints of our setting, treatment groups generally consist of at least two, and up to five participants.
Staffing: Two group leaders and one student-assistant are present for every five participants in the playgroup.
For the primary efficiency measurements the project uses: ADHD-RS-IV (Attention Deficit Hyperactivity Disorder Rating Scale fourth edition), a scale for evaluating the severity of the ADHD symptoms, SDQ-DAN (Strengths and Difficulties Questionnaire - Danish translation) focuses upon the child's strengths and weaknesses in accordance with activity and attention, emotional problems, behavioural difficulties etc. For the secondary efficiency measurements the project uses: TCA (Treatment Compliance Assessment) (Halperin et al: in press), which establishes how much time the child spends on each TEAMS activity and television/computer games each day. Each day the parents fill out the TCA, as part of a logbook which also describes compliance with the TEAMS treatment project.
The questionnaires are continuously catalogued in a database facility (SurveyXact).
The TCA instrument is completed weekly during the 8 week TEAMS program.
- Being tested
- TEAMS intervention, Control group
- Keywords
- Attention Deficit Hyperactivity Disorder, Neurocognitive training for preschool children with ADHD, Play intervention for children with ADHD
- 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.
TEAMS interventionBehavioural
In the child group the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development.
Control groupOther
The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.
| Study group | Role | What they receive |
|---|---|---|
| TEAMS intervention | Experimental | Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as primary diagnosis are offered participation in the RCT study of the TEAMS program.
The intervention groups participate in eight weekly group sessions consisting of separate parent- and children's groups.
In the child group, the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development. Receives: Behavioral: TEAMS intervention |
| Control group | Active comparator | The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD (Attention Deficit Hyperactivity Disorder) core symptoms: measured by ADHD-RS IV: 'Attention Deficit Hyperactivity Disorder- symptom rating scale (teacher and parent rated.)
Measured: 1 month, 3 months, 6 months
Secondary outcomes (1)
Compliance with TEAMS program (TCA: Treatment Compliance Assessment)(parent rated)
Measured: paticipants will be followed for the duration of the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatry Roskilde, University of Southern Denmark
- Responsible party
- Principal investigator, Helle Annette Vibholm, MSc, Nurse Specialist, Holbaek Sygehus
- Investigators
- Jesper Pedersed, MD,PH.D, Study chair, Psychiatric Hospital Roskilde: Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918436
- Sponsor's protocol ID
- SJ-331
- Other IDs
- RESUS
- Acronym
- TEAMS
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vibholm HA, Pedersen J, Faltinsen E, Marcussen MH, Gluud C, Storebo OJ. Training, executive, attention and motor skills (TEAMS) training versus standard treatment for preschool children with attention deficit hyperactivity disorder: a randomised clinical trial. BMC Res Notes. 2018 Jun 8;11(1):366. doi: 10.1186/s13104-018-3478-3.
PubMed 29884212
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAMS (Training Executive, Attention, and Motor Skills): - Intervention Program for Preschoolers With ADHD (Attention Deficit Hyperactivity Disorder). A Rct. Proof-of-Concept Study.
- ClinicalTrials.gov ID
- NCT01918436
- Acronym / sponsor ID
- TEAMS / SJ-331
- Keywords
- Attention Deficit Hyperactivity Disorder, Neurocognitive training for preschool children with ADHD, Play intervention for children with ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Psychiatry Roskilde, University of Southern Denmark
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Aug 2013 (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.
Background:
TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological, neurocognitive intervention program targeted preschool children with ADHD developed by Professor Jeffrey Halperin, and his team from New York University. The uniqueness of this program lies in the concept, based on stimulating neurocognitive growth through focused physical activity and play (Halperin et al.; 2011, 2012, in press).
Teams hypotheses:
TEAMS is based on the notions that:
- The behavioural manifestations of ADHD are the result of deficient neural networks that affect a wide array of neurocognitive and behavioural processes which are not necessarily identical in all children with the disorder.
- Neurodevelopment is sensitive to and can be positively affected by appropriate environmental influences.
- Effective environmental stimulation will be best achieved within a social context.
- The engagement of the child in the core activities of the treatment must be intrinsically rewarding (i.e., fun) in order to facilitate compliance of the intervention.
The initial research by Halperin et al. (2012)indicated significant improvement in ADHD severity from pre- to post-treatment, which also persisted 3 months later.
Objective: The aim of this study is, through a randomized controlled trial (RCT), to validate the TEAMS treatment program in a clinical setting in Denmark.
Method: Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as primary diagnosis are offered participation in the RCT study of the TEAMS program. The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand. The intervention groups participate in eight weekly group sessions consisting of separate parent- and children's groups.
In the child group the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development.
Detailed description
Based on a calculation of strength:
Concurring to a statistically significant outcome the estimated cohort should be minimum 87 children. Based on Region Zealand's visitation history records the cohort is expected to be approximately 100-160 children.
Group size:
The number of participants in each treatment group depends in part on how many children have been recruited. Given the constraints of our setting, treatment groups generally consist of at least two, and up to five participants.
Staffing: Two group leaders and one student-assistant are present for every five participants in the playgroup.
For the primary efficiency measurements the project uses: ADHD-RS-IV (Attention Deficit Hyperactivity Disorder Rating Scale fourth edition), a scale for evaluating the severity of the ADHD symptoms, SDQ-DAN (Strengths and Difficulties Questionnaire - Danish translation) focuses upon the child's strengths and weaknesses in accordance with activity and attention, emotional problems, behavioural difficulties etc. For the secondary efficiency measurements the project uses: TCA (Treatment Compliance Assessment) (Halperin et al: in press), which establishes how much time the child spends on each TEAMS activity and television/computer games each day. Each day the parents fill out the TCA, as part of a logbook which also describes compliance with the TEAMS treatment project.
The questionnaires are continuously catalogued in a database facility (SurveyXact).
The TCA instrument is completed weekly during the 8 week TEAMS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAMS intervention | Experimental | Behavioral: TEAMS interventionPre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as primary diagnosis are offered participation in the RCT study of the TEAMS program. The intervention groups participate in eight weekly group sessions consisting of separate parent- and children's groups. In the child group, the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development. |
| Control group | Active comparator | Other: Control groupThe control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children age 3-6, diagnosed with ADHD as primary diagnosis
Key exclusion criteria (4 listed)
- Children of parents, who are not capable of cooperating in order to implement the program.
- Children living at residential institution or in an unstable environment outside the home.
- Children or parents, who do not speak/understand Danish Children, who are in medical treatment for ADHD.
- Children with significant disabilities due to comorbidity, such as autism, attachment disorder or mental retardation.
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 |
|---|---|---|
| TEAMS interventionIn the child group the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development. | Behavioural | TEAMS intervention |
| Control groupThe control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark. | Other | Control group |
Primary outcome
Change in ADHD (Attention Deficit Hyperactivity Disorder) core symptoms: measured by ADHD-RS IV: 'Attention Deficit Hyperactivity Disorder- symptom rating scale (teacher and parent rated.)
Time frame: 1 month, 3 months, 6 months
1 secondary outcome
Compliance with TEAMS program (TCA: Treatment Compliance Assessment)(parent rated)
Time frame: paticipants will be followed for the duration of the 8 week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 29884212Vibholm HA, Pedersen J, Faltinsen E, Marcussen MH, Gluud C, Storebo OJ. Training, executive, attention and motor skills (TEAMS) training versus standard treatment for preschool children with attention deficit hyperactivity disorder: a randomised clinical trial. BMC Res Notes. 2018 Jun 8;11(1):366. doi: 10.1186/s13104-018-3478-3.
Related trials for ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
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.
Boerne- og Ungdomspsykiatrisk afdeling, Region Sjaelland
Holbæk, Denmark
Jesper Pedersed, MD,PH.D study chair
Psychiatric Hospital Roskilde: Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAMS intervention in people with ADHD and Attention Deficit Disorder With Hyperactivity, run by Holbaek Sygehus at 1 site in Denmark.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD (Attention Deficit Hyperactivity Disorder) core symptoms: measured by ADHD-RS IV: 'Attention Deficit Hyperactivity Disorder- symptom rating scale (teacher and parent rated.) (time frame: 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918436, which also lists 1 linked publication.
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 7 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.