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

NCT ID: NCT01795053

Last Updated: 2017-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-10-31

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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Experimental: playtraining

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo open play session

Intervention Type BEHAVIORAL

Interventions

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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

Intervention Type BEHAVIORAL

Placebo open play session

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Manfred Doepfner

university professor, Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manfred Doepfner, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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

Cologne, Nordrhein-Westfahlen, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Tanja Graefin Wolff Metternich-Kaizman, PhD

Role: primary

Manfred Doepfner, Prof., PhD

Role: backup

Other Identifiers

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playtrainingADHD

Identifier Type: -

Identifier Source: org_study_id

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