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

Not Applicable

• Conditions: ADHD
• Interventions: Behavioral: Placebo open play session

• Registration Number: NCT01795053
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15
• Primary Completion: 2017-07
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open play session	Placebo 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.

Primary Outcome Measures

Name	Time	Method
FBB-ADHD-V	20 minutes	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

Name	Time	Method
VBV-EL SUBSCALE play productivity and play-intensity	10 minutes	questionnaire for preschoolers VBV-EL (=parent version) VBV-ER (=preschool teacher version)focussing items that cover play behavior and restless/ hyperactive behavior

Trial Locations

Locations (1)

University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatry; 🇩🇪 Cologne, Nordrhein-Westfahlen, Germany