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

NCT01918436 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-08-07

No results posted yet for this study

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.

Conditions

  • ADHD
  • Attention Deficit Disorder With Hyperactivity

Interventions

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.

OTHER

Control group

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

Sponsors & Collaborators

  • Psychiatry Roskilde

    collaborator INDUSTRY
  • University of Southern Denmark

    collaborator OTHER
  • Holbaek Sygehus

    lead OTHER

Principal Investigators

  • Jesper Pedersed, MD,PH.D · Psychiatric Hospital Roskilde: Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918436 on ClinicalTrials.gov