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

NCT01918436 | Unknown DMC

• 2 other identifiers: SJ-331RESUS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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. 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. 2.Neurodevelopment is sensitive to and can be positively affected by appropriate environmental influences.
3. 3.Effective environmental stimulation will be best achieved within a social context.
4. 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.

Conditions

ADHD; Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; Neurocognitive training for preschool children with ADHD; Play intervention for children with ADHD

Outcome Measures

Primary Outcomes (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.)

  1 month, 3 months, 6 months

Secondary Outcomes (1)

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

  paticipants will be followed for the duration of the 8 week intervention

Other Outcomes (1)

• Change in Behavioural screening questionnaire SDQ-DAN (Strengths and Difficulties Questionnaires - DANISH translation)(parent and teacher rated)

  1 month, 3 months, 6 months

Study Arms (2)

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.

Behavioral: TEAMS intervention

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

TEAMS intervention BEHAVIORAL

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.

TEAMS intervention

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holbaek Sygehus: lead
• Psychiatry Roskilde: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Boerne- og Ungdomspsykiatrisk afdeling, Region Sjaelland

Holbæk, 4300, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 29884212 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jesper Pedersed, MD,PH.D

  Psychiatric Hospital Roskilde: Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc, Nurse Specialist.

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 7, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

DK (1)