search
Back to results

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

Primary Purpose

ADHD, Attention Deficit Disorder With Hyperactivity

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
TEAMS intervention
Control group
Sponsored by
Holbaek Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Attention Deficit Hyperactivity Disorder, Neurocognitive training for preschool children with ADHD, Play intervention for children with ADHD

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boerne- og Ungdomspsykiatrisk afdeling, Region SjaellandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEAMS intervention

Control group

Arm Description

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.

The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Compliance with TEAMS program (TCA: Treatment Compliance Assessment)(parent rated)

Full Information

First Posted
August 2, 2013
Last Updated
August 6, 2013
Sponsor
Holbaek Sygehus
Collaborators
Psychiatry Roskilde, University of Southern Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT01918436
Brief Title
RCT, Proof of Concept Study of TEAMS (Training Executive, Attention and Motor Skills) Intervention Program
Acronym
TEAMS
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holbaek Sygehus
Collaborators
Psychiatry Roskilde, University of Southern Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Hyperactivity Disorder, Neurocognitive training for preschool children with ADHD, Play intervention for children with ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAMS intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.
Intervention Type
Behavioral
Intervention Name(s)
TEAMS intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Pedersed, MD,PH.D
Organizational Affiliation
Psychiatric Hospital Roskilde: Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Boerne- og Ungdomspsykiatrisk afdeling, Region Sjaelland
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helle A. Vibholm, MSc,Ns.spec.
Phone
+45 59 48 47 30
Email
hevi@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Jesper Petersen, MD,Phd.

12. IPD Sharing Statement

Citations:
PubMed Identifier
29884212
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs