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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01795053
• Other study ID #: playtrainingADHD
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2012
• Last updated: March 14, 2017
• Start date: February 2012
• Est. completion date: October 2017

Study information

• Verified date: March 2017
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• 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
• Placebo open play session

Locations

Country	Name	City	State
Germany	University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatry	Cologne	Nordrhein-Westfahlen

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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