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

NCT01795053 | Unknown DMC

• 1 other identifier: playtrainingADHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD preschoolers; playtraining; child-focused intervention

Outcome Measures

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

  20 minutes

Secondary Outcomes (1)

• VBV-EL SUBSCALE play productivity and play-intensity

  10 minutes

Study Arms (2)

playtraining

EXPERIMENTAL

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

open play session

PLACEBO COMPARATOR

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

Experimental: playtraining BEHAVIORAL

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

playtraining

Placebo open play session BEHAVIORAL

open play session

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatry

Cologne, Nordrhein-Westfahlen, D-50931, Germany

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Manfred Doepfner, Prof., PhD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university professor, Phd

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: February 20, 2013
• Study Start: February 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

DE (1)