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Research Article                                                                                                                                        Open Access

## A multicenter, randomized, controlled study of Training Executive, Attention, and Motor Skills (TEAMS) in Danish preschool children with attention-deficit/hyperactivity disorder: Rationale and description of the intervention and study protocol

Helle Annette Vibholm 1* , Jesper Pedersen 2 , Anne Holm 1 , and Søren Krue 1

1  Child Psychiatric Daytime ADHD Clinic, Child and Adolescent Psychiatric Centre,

Region Zealand, Holbaek, Denmark 2  Child and Adolescent Psychiatric Centre, Region Zealand, Roskilde, Denmark

*Corresponding author:

hevi@regionsjaelland.dk

## Abstract

Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent neurodevelopmental disorder that is often detected during the preschool years. Neuroimaging data indicate that children with ADHD have brains that are characterized  by  growth  and  functional  anomalies.  Data  suggest  that  the  diminution  of  ADHD  symptoms  is  correlated  with improved neural functioning and growth. On the basis  of these findings,  interventions  that  target  neural  growth,  which indicates neural development, can possibly lead to a more enduring treatment for ADHD. Training Executive, Attention, and Motor Skills (TEAMS) is a non-pharmacological neurocognitive intervention program that targets preschool children with ADHD. The program is designed to stimulate neurocognitive growth through physical activity and play in combination with psychoeducation and guidance for the parents.

Population: Children between the ages of three and six years from Region Zealand in Denmark who have been diagnosed with ADHD are offered participation in the trial. According to a calculation of the strength needed to result in a statistically significant outcome, the estimated group size should be, at minimum, 87 children. On the basis of Region Zealand's visitation history records, the cohort is expected to include approximately 100 to 120 children.

Method: The intervention groups participate in eight weekly group sessions that consist of separate parent and children's groups. The control groups receive the standard treatment program as outlined by the clinical guidelines of Region Zealand. The  ADHD Rating  Scale-IV  and the  Danish  version  of  the  Strengths  and  Difficulties  Questionnaire  are  used  to  assess ADHD symptom severity before and after the intervention and to monitor the duration of the outcome. A comparative analysis of data from the intervention and control groups will illustrate the study's results.

Study aim: This is a multicenter, randomized, controlled, single-blind, parallel-group study with the primary aims of testing the  TEAMS concept and investigating whether the intervention significantly lowers ADHD symptoms and increases the functionality level after the intervention as compared with the control group. A secondary aim is to monitor the duration and endurance of the outcome for six months after the intervention. This study is currently in progress. Full results and conclusions will be reported after the study's completion in 2015.

Key  words: Attention-deficit/hyperactivity  disorder,  preschool,  group  interventions,  TEAMS  intervention,  randomized controlled trial

## Trial registration

This  trial  is  registered  with  ClinicalTrial.Gov:  registration  no.  NCT01918436.  It  is  also  registered  with  Region's  Zealand Committee on Health Research Ethics: project registration number 34758, project number SJ-331. The project involves the use of the OPEN Randomize tool (Odense Patient data Explorative Network), and it is registered with the number OP\_38.

## Background

Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent neurodevelopmental disorder that is  typically  detected  during  the  preschool  years. ADHD  is  recognized  as  a  chronic  disorder,  with some  associated  difficulties  persisting  into  adulthood (1-4).

There  are  several  evidence-based  psychopharmacologic (5-7) and behavioral interventions for school-aged children  with  ADHD  that  provide short-term symptomatic relief (8-11). Unfortunately, such  gains  are  rarely  documented  as  being  maintained after the termination of treatment (12-20).

In addition, studies have shown that few individuals with ADHD receive effective treatment throughout  the  full  course  of  their  disorder  (21). Therefore,  the  development  of  novel  treatments that provide enduring therapeutic benefits by altering  the  chronic  and  often  incapacitating  course  of the disorder could have a huge impact on the individual  as  well  as  on  society,  in  terms  of  both  cost and human suffering.

Recent research has begun to clarify the underlying neural and neurocognitive determinants of ADHD  and  may  thus  provide  guidance  for  the development of interventions that have more lasting effects.  Neuroimaging  data  indicate  that  children with  ADHD have brains that are  characterized  by delayed, if not permanently stunted, growth as well as  by  functional  anomalies.  These  are  apparent throughout much of the neocortex as well as other parts  of  the  brain  (22-27).  Emerging  neuroimaging and neuropsychological data suggest that the diminution of ADHD symptoms is linked to the development  of  improved  neural  functioning  (28;29). These findings suggest that interventions that target neural growth and development may provide more sustainable  ADHD treatment.  The scientific  literature  demonstrates  that  neurodevelopmental  processes are highly responsive to environmental influences,  particularly  environmental  enrichment  and physical exercise (30;31).

Because  early  childhood  is  a  critical  period  for brain  development,  it  has  been  argued  that  early intervention can be extremely vital (32-35). This has been  supported  by  Halperin  and  colleagues  who studied an intervention that had the aim of addressing the array of neurodevelopmental disorders that are consistent with ADHD (32-36).

## Intervention hypotheses

The program used in this study - Training Executive, Attention,  and  Motor  Skills  (TEAMS)  -  was  designed by Professor Jeffrey Halperin and his team at New  York  University  to  enhance  brain  development and to precipitate enduring changes that could modify the developmental course of  ADHD. Halperin's preliminary results were quite promising (37;38).

The main theory behind the TEAMS program is that  the  way  children  live their  lives  has  an  impact on  brain  development,  which  in  turn  can  alter  the severity  and  trajectory  of  ADHD,  and  potentially other neurodevelopmental disabilities. TEAMS consists of a menu of game-like activities that place demands on an array of neurocognitive and motor skills; these are interspersed with periods of physical exercise and relaxation exercises. Most data suggest that  ADHD  is  the  result  of  deficient  neural  networks that affect a wide array of neurocognitive and behavioral processes, including - but not limited to inhibitory control, working memory, planning, and a range  of  other  executive  and  non-executive  functions. TEAMS' games and activities are designed to improve such neurocognitive domains. Specifically, they  are  designed  to  enhance  working  memory, inhibitory  control,  visual  and  spatial  planning,  and motor  skills.  Most  activities  also  involve  multiple cognitive  and  behavioral  functions,  including  selfregulation as well as sustained attention and concentration.  In  addition,  TEAMS  actively  incorporates aerobic  physical  exercise  and  relaxation  techniques into  the  program.  Aerobic  physical  exercise  has consistently  been shown to stimulate  brain  growth and  development,  and  relaxation  is  another  approach  to  facilitating  attention  and  inhibitory  control  while  teaching  children  purposeful  winding down (31;36;39).

## TEAMS is based on the following hypotheses:

1. The behavioral manifestations of ADHD are the  result  of  deficient  neural  networks  that affect a wide array of neurocognitive and behavioral processes, which are not necessarily identical in all children with the disorder
2. Neurodevelopment is sensitive to and can be positively  affected  by  appropriate  environmental influences (39)
3. Effective  environmental  stimulation  will  be best achieved within a social context
4. The engagement of the child in the core activities  of  the  treatment must be intrinsically rewarding (i.e., fun) rather than only extrinsically reinforced (i.e., with rewards or tokens) to facilitate the self-imposed continuation of the intervention, which will lead to generalization over time and across settings

## Study aim

This  is  a  multicenter,  randomized,  and  controlled, single-blind, and parallel group study.

The  aims  of  this  study  are  to  test  the  TEAMS concept and to investigate whether the intervention significantly lowers ADHD symptoms and increases the functionality level after the intervention as compared with the control group. Furthermore, we wish to  examine whether the effects are still present six months after the intervention. If the intervention is proved to have a significant effect, the ambition is to implement the TEAMS method as an addition to the existing treatment program in Region Zealand's child psychiatry department. By improving the child's  cognitive  and  social  competence,  this  intervention may possibly ease the difficulties and suffering that are often related to starting school.

## Sample and recruitment

Children  from  Region  Zealand  are  diagnosed  with ADHD  after  thorough  examination  and  on  the basis of the clinical guidelines as well as 10 th  revision of the International Statistical Classification of Diseases  and  Related  Health  Problems  and Diagnostic and  Statistical  Manual  of  Mental  Disorders criteria  (1). The clinical guidelines prescribe a minimum exami-

nation that consists of the following:

1. Patient anamnesis, information from the child's kindergarten or preschool, and, if necessary,  information  from  social  services  and municipal files
2. Clinical  assessment,  including  play  observation, kindergarten and preschool observation, and  a  home  visit;  neurological  evaluation; blood  pressure,  pulse,  height,  and  weight measurement;  and  heart  and  lung  stethoscope evaluation
3. Paraclinical  examination  that  includes  blood testing, electrocardiography, and electroencephalography  if  anamnesis  or  clinical  assessment arouses the suspicion of a somatic condition
4. Specialized testing, including cognitive testing, projective testing, neuropsychological testing, and  ADHD  Rating  Scale-IV  (ADHD-RSIV)  evaluation  from  the  child's  parents  and preschool or kindergarten teacher (40)

Children who are between the ages of three and six  years,  who  are  diagnosed  with  ADHD  as  their primary diagnosis, and who fit the established inclusion criteria are referred to further treatment in the ADHD clinic in Holbaek, Denmark.

The families are invited to an individual meeting at the clinic, where they are informed about existing treatment options in Region Zealand, including the possibility  of  participating  in  the  TEAMS  project. During the  first  meeting,  it  is  determined  whether or  not  the  child  and  his  or  her  family  can  comply with  the  criteria  of  the  project  and  if  they  wish  to participate. After agreeing to participate in the project,  the  parents  sign  a  declaration  of  agreement. The child is then randomized to either the intervention group or the control group with the use of the OPEN Randomize tool.

After the families are randomized, they receive an informational  letter  in  the  mail  in  which  they  are informed of which group they will be following. In this  letter  is  also  included  a  meeting  schedule,  Region  Zealand's  rules  for  mileage  allowance,  an  inquiry forms for the ADHD-RS-IV and for the Danish  version  of the  Strengths  and  Difficulties  Questionnaire (SDQ-DAN) (41;42). Both forms must be completed  by  the  child's  parents  as  well  as  his  or her  primary  preschool  or  kindergarten  teacher  and then returned to the group leader at the first meeting. The members of the intervention group receive an additional form including the rules of the child's group; this form must also be signed and returned to the group leader at the first group session. For a quick overview, see flowchart, Figure 1.

The inclusion criteria are as follows:

- Children  between  the  ages  of  three  and  six years  who  have  ADHD  as their  primary  diagnosis

The exclusion criteria are as follows:

- Children  of  parents  who  are  not  capable  of cooperating to implement the program
- Children who are living in a residential institution or in an unstable environment outside of the home
- Children or parents who do not speak or understand the Danish language
- Children who are taking medication for ADHD
- Children  with  significant  disabilities  as  a  result  of  comorbidity  such  as autism,  attachment disorder, or mental retardation

The  project  design  and  method  have  been  approved  by  Region  Zealand  University  Hospital, Region's  Zealand  Committee  on  Health  Research Ethics, and the Danish Data Protection Agency.

Recruitment  from  the  ADHD  clinics  in  Region Zealand will be ongoing until June 2015.

Assessment of patients according to

inclusion and exclusion criteria

(n = 120)

Recruitment

FIGURE 1. Flowchart showing project outline

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## TEAMS

TEAMS  is  administered  within  the  context  of  a small-group  setting  (i.e.,  two  to  five  families)  and consists  of  eight  weekly  separate  parent  and  child group sessions in the clinic.

The notion of 'keeping it fun' plays a central role in  both  the  child  and  parent  groups.  Parents  and children  must  find  TEAMS  sessions  enjoyable  to support  their  compliance  with  the  treatment.  The more enjoyable the games, the more likely it is that they will be played and that neurocognitive growth will  thus  be  stimulated.  The  importance  of  having fun together as a family is emphasized by the program,  both  to  facilitate  treatment  compliance  and generalization  and  to  benefit  parent-child  relationships.  The  intervention  does  not  include  pharmacological  treatment  during  the  time  period  of  the intervention.

## Staffing

Two  group  leaders  and  one  student  assistant  are present  in  the  playgroup.  The  group  leaders  have extensive training in the management  of  such groups  and  in  the  implementation  of  behavioral procedures. The primary group leader manages the parent  sessions  while  the  other  staff  members  attend  the  children  in  a  coexisting  play  area,  where they are offered a healthy snack and a cold beverage. After the parent's group session is completed, it is the  children's  turn  to  participate  in  the  children's group. While the children are active, the parents can relax in a coexisting waiting room, where they also have  an  opportunity  to  get  acquainted  and  to  discuss  their  experiences  in  a  more  informal  atmosphere.

## Parent group

A  main  component  of  the  parent  intervention  involves psychoeducation, collaborative problem solving,  and  facilitating  the  child's  consistent  engagement  in  TEAMS-related  activities  outside  of the clinical setting.

Specific  topics  about  which  the  parents  receive instruction include the following:

1. The  etiology  of  ADHD,  the  manifestations of ADHD symptoms across the lifespan, and the framework and philosophy behind TEAMS
2. Symptoms and developmental trends in ADHD; comorbidity
3. Evidence-based treatments: medication
4. Evidence-based treatments: psychosocial treatment of ADHD
5. ADHD and sleep disorders
6. ADHD and nutrition
7. Sibling and family relationships and ADHD
8. Resources for children and families with ADHD

Each topic is accompanied by a handout that provides a brief synopsis of key discussion points; this handout can be accessed for later reference.

Each parent session starts with an outline of the current session and is followed by an evaluation of the past week's experiences. Here the clinician and the families can assess any progress or setbacks that families may have experienced during the week and provide encouragement to each other with regard to the  continued  engagement  of  their  children  in  the program's games and goals. This also allows families to  clarify  issues  that  they  have  encountered  during the previous week.

The parents are then informed of and instructed in the coming week's activities by the group leader, who provides  a  brief  description  of  each  task  and links  each  activity  to  its  underlying  skill  sets.  Each week there are new games and activities. During the meetings, it is stressed that these activities are to be carried out for 30 to 45 minutes every day and that the children should engage in at least 20 minutes of exercise  for  a  minimum  of  three  days  per  week. Parents  are  also  asked  to  complete  a  relaxation module each day (31;36;38).

Parents are encouraged to adapt TEAMS games, activities,  and  exercises  to  fit  their  children's  skill levels and to continually create new and more ageappropriate activities for their children as they grow older;  this  is  known  as scaffolding. Scaffolding  is  a central part of the conceptual basis of TEAMS, and it  refers  to  gradual  systematic  increases  in  task  demands. The process of scaffolding slowly increases the  cognitive  and  motor  demands  of  games  and activities  with  the  aim  of  gradually  increasing  the level of mastery (31;36;38;43).

Parents are told to allow children some degree of choice in selecting the games that they wish to play. At  the  same  time,  parents  must  ensure  that  all TEAMS domains are covered during the course of a given week.

Parents  are  asked  to  complete  daily  diaries  with the  use  of  a  preprinted  'Treatment  Compliance Assessment' form, which is used to monitor compliance  with  the  program  within  the  home  setting. Each week, the parents hand in the completed diaries  and  receive  a  new  one  that  is  specific  to  the coming week's activities.

## Children's group

After the parent group meeting has ended, it is time for the children to play. The activities that the group leader  has  described  to  the  parent  group  are  now introduced to the children. An average of four new games and activities are introduced each week.

Each session consists of two units, both of which include a five-minute warm-up (e.g., jumping jacks, dancing)  and  15  minutes  of  games  and  activities. Between  the  two  units,  the  children  are  offered  a short break and a drink of water.

To ensure behavior management within the group setting,  children  are  reminded  of  the  rules  of  the children's  group  and  praised  for  their  participation and  good  fellowship.  Enjoyment  of  the  games  is emphasized so  that  children  play  for  the  fun  of  it rather  than  for  prizes  or  rewards.  Because  most games involve some form of skill development, the group  leader  matches  the  level  of  difficulty  to  the child's  actual  abilities.  Games  are  introduced  with enthusiasm, played in a mutually supportive atmosphere,  and  terminated  before  moving  on  to  other activities by reinforcing the children's success in the games and encouraging them to play the games with their parents (31;36;38).

## Visualizing the games and activities

A description of each game or activity is printed on small illustrated  card  that  includes  instructions  and tips for scaffolding. Each card is color coded, with each  color  corresponding  to  a  particular  cognitive domain:

- Red games: motor control (e.g., hopscotch)
- Green games: memory (e.g., memory matching games)
- Yellow games:  visual-spatial  skills  and  planning (e.g., tic-tac-toe)
- Blue games:  inhibitory  control  (e.g.,  freeze dancing)
- Black games: exercise (e.g., biking)

- Purple games: relaxation (e.g., deepbreathing exercises)

Each child in the group is given a small cardboard suitcase  in  which  they  can  store  the  activity  cards. New games and activities are added to the suitcase every week.

## Control group intervention

The  families  that  are  randomized  to  the  control group  are  offered  the  conventional  treatment  regime from Region Zealand. The conventional treatment mainly takes place in one of the region's four outpatient clinics. For the sake of this study, all controlgroup patients are also followed by the group  leader  in  the  Holbaek  clinic,  for  the  whole intervention period. The treatment regime for ADHD  consists  of  a  combination  of  specialized education,  psychoeducation  targeted  at  both  the child  and  the  parents,  and  network  contact  and cooperation.  Families  are  also  given  guidance  regarding positive social training, nutrition, sleep, and exercise  as  well  as  they  prevention  of  antisocial behavior  and  conduct  problems.  Pharmacological treatment  can  be  supplementary,  but  it  is  not  offered  during  the  intervention  period.  The  control groups  receive  three  1-hour  individual  counseling sessions  that  are  focused  on  each  child's  specific needs.

If, for some reason, the child does start receiving medication, he or she is excluded from the study.

## Measuring results and analysis

For the primary impact measurements, the ADHDRS-IV and the SDQ-DAN are used. The ADHDRS-IV  is  a  validated  18-item  scale  that  rates  the severity  of  ADHD  symptoms.  Each  item  corresponds  to  one  of  the  18  items  on  the  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, symptom checklist that is used to diagnose ADHD (44). The SDQ-DAN instrument has been validated, and it corresponds to the 10 th  revision of the  International  Statistical  Classification  of  Diseases  and  Related  Health  Problems and  Diagnostic and  Statistical  Manual  of  Mental  Disorders,  Fourth  Edition, criteria for the diagnosis of ADHD. It consists of 25 statements that focus on the child's strengths and  weaknesses  involving  activity,  attention,  emotional  problems,  behavioral  difficulties,  and  so  on (34).  Both  the  ADHD-RS-IV  and  the  SDQ-DAN exist  in  parent/teacher  versions  as  well  as  versions that  have  been  modified  to  fit  various  age  groups (42).

A secondary impact measurement is also used. The Treatment Compliance Assessment is a journal-like log that was developed by Halperin and colleagues to  induce  compliance  with  the  TEAMS  treatment program.  It  is  used  to  record  the  time  spent  on TEAMS-related  and  non-TEAMS-related  activities on a weekly basis (31;38).

The  intervention  group  receives  ADHD-RS-IV and  SDQ-DAN questionnaires by mail. The questionnaires  are  completed  by  the  parents  and  the children's  primary  teachers  before  the  first  group meeting, directly after the last week of the program, and then again one, three, and six months after the termination  of  the  intervention.  After  six  months, an individual evaluation meeting is held in the clinic, where the child's current status and future treatment plan are discussed.

The  same  principles  also  apply  for  the  control groups.

## Blinding

The  interventions  are  not  blinded  to  participants, parents,  treating  physicians,  or  personnel  in  the clinic.  However,  the  outcome  assessor  of  the  primary and secondary outcomes is the teachers, who are kept blinded with regard to the child's allocated intervention.  The  involved parties  (i.e.,  the  parents and  the  children)  are  instructed  not  to  inform  the teacher of the allocation. To secure the integrity of trial  data,  the  principal  investigator  who  will  be collecting  the  questionnaires  will  be  blind  to  the intervention.  Blinded  data  will  be  handed  over  to the  South  Danish  University  via  the  OPEN  database; the university will be blinded to the interventions and will be in charge of data entry and statistical  analyses.  Standardized  procedures  will  be  ensured.

## Statistical and outcome analysis

The  questionnaires  are  all  continuously  catalogued in  the  SurveyXact  database  at  Odense  University, Denmark.  SurveyXact  is  a  web-based  application developed  by  Ramboll,  Copenhagen  Denmark  for the  management  of  questionnaires.  This  database will  be  used  for  data  entry,  data  storage,  and  data extraction.

The  sample  size  is  calculated  on  the  basis  of  a type I error (α) of 5% and a type II error (β) of 20% (thereby resulting in a power of 80%), with an allocation ratio of 1:1. With a clinically relevant difference of a score of three between the experimental intervention  group  and  the  control  group  on  the ADHD-RS-IV (primary outcome) and an assumed standard deviation of five on the same scale, a sample size of 45 participants in each group is needed. With an estimated withdrawal of approximately 30 patients, this corresponds to a total of 120 random- ized participants. For missing follow-up data (>5%), multiple imputations will be conducted.

To  statistically  evaluate  the  effect  size  of  the TEAMS  intervention,  we  will  use  the  same  approach that was used in the preliminary research by Halperin  and  his  team  (31;38).  Halperin  describes the data analysis as follows:

## Plan for the analyses

The statistical analysis of the outcomes will be based on the 'intention-to-treat' principle: all randomized participants  will  be  included  in  the  analysis  in  the intervention group to which they were randomized, irrespective  of  how  much  of  the  intervention  they have  received.  Per-protocol  analyses  will  be  conducted  secondarily  for  the  participants  who  have completed 50% or more of their randomized intervention. According to the International Conference on  Harmonization  Tripartite  Guideline,  Statistical Principles  for  Clinical  Trials  E9  Analysis  of  Drug Trials (45), the analyses will primarily be conducted with adjustment for stratification variables and will secondarily  be  conducted  without  adjustment  for stratification variables. Descriptive statistics for the two  groups  will  be  generated.  To  investigate  the statistical  analyses  of  a  possible  effect,  the  mixed model  repeated  measures  method  will  be  used  to test the effect of the intervention and the effect of time.  The  significance  level  will  be  set  at P < 0.05. All  effect  measures  will  be inspected  for  normality and transformed as appropriate. Missing values will be handled via the multiple imputation method.

## Discussion

The  TEAMS  program  manual  is  still  being  improved  by  Professor  Halperin  and  his  team.  The manual that this project is based on is an unedited edition that was kindly released to us by Professor Halperin  so  that  we  could  test  the  program  in  a randomized, controlled study outside of the United States.

In  response  to  cultural,  linguistic,  and  demographic differences, it was necessary to translate the manual  into  Danish  and  to  adjust  some  of  the guidelines  to  fit  Danish  society,  clinical  resources, logistic possibilities, and Danish legislation.

Examples of such modifications include not paying  the  participants  to  attend  and  not  giving  the children  prizes  or  rewards  for  participating  in  the playgroup.

It  was  also  necessary  to  translate  the  TEAMS game cards. The games themselves are crossculturally identifiable, so relevant Danish titles were used rather than directly translating the game names.

Most  children  in  Denmark  attend  kindergarten, and the majority of primary caretakers in Denmark work outside of the home. To accommodate this, it has  been  necessary  to  schedule  the  group  sessions late  in  the  afternoon  so  that  they  do  not  interfere too much with the families' domestic lives. We expect  that  this  may  involve  the  children  being  tired when they arrive after a long day, which could make their cooperation more challenging.

Initially the TEAMS program was designed to be an  eight-week  course,  but  it  was  later  modified  to consist of only five weekly sessions. A new outline was created that  concurred with  the  original  eightweek outline. This project will thus follow the initial outline  based  on  the  assumption  that  the  reduced program, in our clinical setting, would not provide the time necessary to establish the positive connection  with  the  families  that  is  needed  for  positive collaboration  in  the  group  sessions.  This  assumption is based on the late appointment schedule and the recruitment design. Most families are new to the surroundings  and  to  the  clinical  staff,  because  we are  recruiting  from  four  different  geographic  areas of  Region  Zealand.  We  anticipate  that  this  might result  in  the  families  and  children  needing  time  to adjust  before  they  can  be  confident  and  relaxed enough  in  the  new  environment  to  optimally  participate in the intervention.

It is well documented that psychostimulant medication  has  a  positive  effect  on  ADHD  symptoms. In  Denmark, psychostimulant medication is generally  not  an  acceptable  treatment  for  children  who are less than six years old. Therefore, it is not considered unethical to prolong the participants' inability  to  obtain  this  type  of  treatment  by  engaging them  in  the  study.  In  addition,  the  intervention period is short, and, during the intervention period, the  families  and  their  networks  are  offered  a  high level  of  psychoeducation,  which  is  considered  the first  choice  from  among  the  available  treatment strategies  for  this  condition.  It  is  also  well  known that psychostimulant medication is no longer potent for  these  individuals  after  treatment  is  terminated. Thus,  it  has  been  contemplated  that  the  intervention presented by this study could possibly result in more  durable  symptom  relief  (on  the  basis  of  the hypothesis of TEAMS) and that the targeted activities may create neurocognitive growth, thereby possibly  diminishing  ADHD  symptoms  on  a  more permanent basis.

An  apparent  limitation  of  this  study  is  the  resources available for the group work. It is only possible  to  have  one  group  at  a  time,  which  prolongs the  study  and  causes  waiting  lists  to  be  necessary, thereby forcing families to wait until the next group starts  up.  Because  we  recruit  from  four  different locations, the families must relate to many different professionals; this can have an effect on the family's relationships  with  the  professionals,  which  in  this case  may  obstruct  learning  and  inhibit  the  family's response to the group leaders. In addition, in some instances, participants have a long way to travel late in  the  afternoon,  which  can  also  have  a  negative impact on the general outcome.

This study has a very simple design and is considered  to  be  low-tech  according  to  instruments  and accessories that are needed for the groups, both of which can be considered as strengths. The concept of  the  program  is  also  very  positive:  the  children and their families have fun together; they learn and evolve  while  building  bonds  and  having  positive relations.  It  is  a  safe,  ethically  strong  study  that  is instructive, educational, and fun.

## Trial status

This  project  is  still  recruiting  and  is  currently  in progress. The first three  trial  groups  have  successfully been completed. Data will be evaluated in October 2015, at which time results will be published in acknowledged national and international journals.

## Competing interests

The  authors  declare  that  they  have  no  competing interests.

## Acknowledgements

This  study  was  financially  supported  by  Region Zealand University Hospital (RESUS), Region Zealand Research Foundation. The funding bodies have no role in the design of this study; in the collection, analysis, and interpretation of data; or in the writing of this manuscript.

Odense Patient data Explorative Network (OPEN)  has  supported  this  study  by  providing access  to  the  OPEN  Randomize  and  SurveyXact database facilities at Odense University.

Jeffrey  M.  Halperin,  PhD, of  the  Department  of Psychology at Queens College (New York, NY) and The Graduate Centre at the City University of New York (New York, NY) has given the authors of this study permission to cite his work and to conduct a randomized, controlled study to further the ongoing development of the TEAMS program.

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