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

ADHD Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01918436
• Other study ID #: SJ-331
• Secondary ID: RESUS
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2013
• Last updated: August 6, 2013
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Boerne- og Ungdomspsykiatrisk afdeling, Region Sjaelland	Holbaek

Sponsors (3)

Lead Sponsor	Collaborator
Holbaek Sygehus	Psychiatry Roskilde, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Behavioural screening questionnaire SDQ-DAN (Strengths and Difficulties Questionnaires - DANISH translation)(parent and teacher rated)		1 month, 3 months, 6 months	No
Primary	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	No
Secondary	Compliance with TEAMS program (TCA: Treatment Compliance Assessment)(parent rated)		paticipants will be followed for the duration of the 8 week intervention	No