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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: Experimental: playtraining
* Behavioral: Placebo open play session


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: playtraining<br>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<br>* 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<br>|
| Placebo Comparator: open play session<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD preschoolers, playtraining, child-focused intervention