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RCT, Proof of Concept Study of TEAMS (Training Executive, Attention and Motor Skills) Intervention Program (TEAMS)

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ClinicalTrials.gov Identifier: NCT01918436
Recruitment Status : Unknown
Verified August 2013 by Helle Annette Vibholm, MSc, Nurse Specialist, Holbaek Sygehus.
Recruitment status was:  Recruiting
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Collaborators:
Psychiatry Roskilde
University of Southern Denmark
Information provided by (Responsible Party):
Helle Annette Vibholm, MSc, Nurse Specialist, Holbaek Sygehus

Brief 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. 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:

  1. 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.
  2. Neurodevelopment is sensitive to and can be positively affected by appropriate environmental influences.
  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) 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.


Condition or disease Intervention/treatment Phase
ADHD Attention Deficit Disorder With Hyperactivity Behavioral: TEAMS intervention Other: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TEAMS intervention

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.

Behavioral: TEAMS intervention
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.

Active Comparator: Control group
The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.
Other: Control group
The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Compliance with TEAMS program (TCA: Treatment Compliance Assessment)(parent rated) [ Time Frame: paticipants will be followed for the duration of the 8 week intervention ]

Other Outcome Measures:
  1. Change in Behavioural screening questionnaire SDQ-DAN (Strengths and Difficulties Questionnaires - DANISH translation)(parent and teacher rated) [ Time Frame: 1 month, 3 months, 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children age 3-6, diagnosed with ADHD as primary diagnosis

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918436


Locations
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Denmark
Boerne- og Ungdomspsykiatrisk afdeling, Region Sjaelland Recruiting
Holbaek, Denmark, 4300
Contact: Helle A. Vibholm, MSc,Ns.spec.    +45 59 48 47 30    hevi@regionsjaelland.dk   
Principal Investigator: Jesper Petersen, MD,Phd.         
Sponsors and Collaborators
Holbaek Sygehus
Psychiatry Roskilde
University of Southern Denmark
Investigators
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Study Chair: Jesper Pedersed, MD,PH.D Psychiatric Hospital Roskilde: Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helle Annette Vibholm, MSc, Nurse Specialist, Msc, Nurse Specialist., Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT01918436    
Other Study ID Numbers: SJ-331
RESUS ( Other Grant/Funding Number: Region Zealand Psychiatric Research Unit )
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013
Keywords provided by Helle Annette Vibholm, MSc, Nurse Specialist, Holbaek Sygehus:
Attention Deficit Hyperactivity Disorder
Neurocognitive training for preschool children with ADHD
Play intervention for children with ADHD
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases