Back to resultsEffects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity
Primary Purpose
ADHD
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Experimental: playtraining
Placebo open play session
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD preschoolers, playtraining, child-focused intervention
Eligibility Criteria
Inclusion Criteria: Diagnosis of ADHD or combinde ADHD/ ODD, age 3 to 6, 5 Items regarding play behavior on DSM-IV symptom checklist above 95th percentile, parents motivation to provide 15 to 30 weekly sessions
Exclusion Criteria: Autism Spectrum Disorder, IQ below 80, massive actual impairment, that requests sudden in-patient treatment, school entry in less than 2 months
Sites / Locations
- University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
playtraining
open play session
Arm Description
playtraining is a play based intervention that includes techniques of behavioral management as: structuring of play situation, detailled play planning, definition of behavioral tasks, positive reinforcement, token economy. The intervention is designed to enhance play-persistence and intensity and thereby reduce ADHD symptoms
the open play sessions are conducted in the same rooms, by the same staff and in the same time frame as the experimental sessions. The therapist plays with the child without structuring the sitauation through behavioral tecniques. The play situation is designed to be ineresting and comfortable for the child.
Outcomes
Primary Outcome Measures
FBB-ADHD-V
Symptom checklist, rated by parents and preschool teachers. Standardized quesionnaire based on the DSM-IV diagnostic criteria for ADHD. Specific form for preschoolers with norms from the year 2009
Secondary Outcome Measures
VBV-EL SUBSCALE play productivity and play-intensity
questionnaire for preschoolers VBV-EL (=parent version) VBV-ER (=preschool teacher version)focussing items that cover play behavior and restless/ hyperactive behavior
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01795053
Brief Title
Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity
Official Title
Randomized Controlled Trial to Evalualte Effects of Playtraining as Manualized in THOP, a Modulized German ADHD Manual, in 3 to 6 Year Old Children With a Diagnosis of ADHD on ADHD Symptoms and Play Persistence and Intensity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A sample of 60 children is randomly assigned to an intervention and a control condition. The intervention group receives 15 sessions of child-focused treatment with play training to enhance play persistence and intensity. The control group receives the same amount of placebo play sessions. The intervention group receives subsequently 15 sessions of parent training. All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in the intervention than in the control group. Play-persistence and -intensity should also increase more in the intervention group. An additional effect of a subsequent parent training shall furthermore be tested.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD preschoolers, playtraining, child-focused intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
playtraining
Arm Type
Experimental
Arm Description
playtraining is a play based intervention that includes techniques of behavioral management as: structuring of play situation, detailled play planning, definition of behavioral tasks, positive reinforcement, token economy. The intervention is designed to enhance play-persistence and intensity and thereby reduce ADHD symptoms
Arm Title
open play session
Arm Type
Placebo Comparator
Arm Description
the open play sessions are conducted in the same rooms, by the same staff and in the same time frame as the experimental sessions. The therapist plays with the child without structuring the sitauation through behavioral tecniques. The play situation is designed to be ineresting and comfortable for the child.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: playtraining
Intervention Description
playtraining is a play based intervention that includes techniques of behavioral management as: structuring of play situation, detailled play planning, definition of behavioral tasks, positive reinforcement, token economy. The intervention is designed to enhance play-persistence and -intensity and thereby reduce ADHD symptoms
Intervention Type
Behavioral
Intervention Name(s)
Placebo open play session
Primary Outcome Measure Information:
Title
FBB-ADHD-V
Description
Symptom checklist, rated by parents and preschool teachers. Standardized quesionnaire based on the DSM-IV diagnostic criteria for ADHD. Specific form for preschoolers with norms from the year 2009
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
VBV-EL SUBSCALE play productivity and play-intensity
Description
questionnaire for preschoolers VBV-EL (=parent version) VBV-ER (=preschool teacher version)focussing items that cover play behavior and restless/ hyperactive behavior
Time Frame
10 minutes
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: Diagnosis of ADHD or combinde ADHD/ ODD, age 3 to 6, 5 Items regarding play behavior on DSM-IV symptom checklist above 95th percentile, parents motivation to provide 15 to 30 weekly sessions
Exclusion Criteria: Autism Spectrum Disorder, IQ below 80, massive actual impairment, that requests sudden in-patient treatment, school entry in less than 2 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Doepfner, Prof., PhD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatry
City
Cologne
State/Province
Nordrhein-Westfahlen
ZIP/Postal Code
D-50931
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja Graefin Wolff Metternich-Kaizman, PhD
Email
tanja.graefin-wolff-metternich@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Manfred Doepfner, Prof., PhD
Email
manfred.doepfner@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Tanja Graefin Wolff Metternich-Kaizman, PhD
12. IPD Sharing Statement
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Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity
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