ClinicalTrials.gg
Status unknownNCT01795053Updated Mar 15, 2017

Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity

An interventional study of Experimental: playtraining and Placebo open play session in ADHD, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2017-03-15.

Sponsored by University of Cologne · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • ADHD

Keywords

  • ADHD preschoolers
  • playtraining
  • child-focused intervention
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    playtraining

    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

    Behavioral: Experimental: playtraining

  • Placebo comparator
    open play session

    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.

    Behavioral: Placebo open play session

Interventions

  • BehavioralExperimental: playtraining

    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

  • BehavioralPlacebo open play session
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 20 minutes

Secondary outcomes

  1. 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

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
  • University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatry
    Cologne, Nordrhein-Westfahlen D-50931, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Jul 2017 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2012
First posted
Feb 20, 2013
Start
Feb 2012
Primary completionEst.
Jul 2017
CompletionEst.
Oct 2017
Last update
Mar 15, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01795053
Responsible party
Manfred Doepfner (university professor, Phd, University of Cologne) — Principal investigator
First posted
Feb 20, 2013
Start date
Feb 2012
Primary completion
Jul 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Mar 15, 2017

Study contacts

Manfred Doepfner, Prof., PhD
principal investigator · University of Cologne

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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