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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00012834
Date of registration:	07/09/2017
Prospective Registration:	Yes
Primary sponsor:	Klinikum der Universität München, Dr. von Haunersches Kinderspital; Pädiatrische Psychosomatik und Psychotherapie
Public title:	Efficacy of prevention programs for children in kindergarden
Scientific title:	Efficacy of prevention programs for children in kindergarden
Date of first enrolment:	21/09/2017
Target sample size:	100
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00012834
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//No treatment / Standard of care; Assignment: parallel; Study design purpose: prevention
Phase:	2

Countries of recruitment
Germany

Contacts

Name:	Romana Stöckl
Address:	Pettenkoferst. 8A 80336 München Germany
Telephone:	+49 89 4400 53705
Email:	Romana.Stoeckl@med.uni-muenchen.de
Affiliation:	Klinikum der Universität München, Dr. von Haunersches Kinderspital; Pädiatrische Psychosomatik und Psychotherapie

Name:	Romana Stöckl
Address:	Pettenkoferstr. 8A 80336 München Germany
Telephone:	+49 89 4400 53705
Email:	Romana.Stoeckl@med.uni-muenchen.de
Affiliation:	Klinikum der Universität München, Dr. von Haunersches Kinderspital; Pädiatrische Psychosomatik und Psychotherapie

Key inclusion & exclusion criteria

Inclusion criteria: ADHD symptoms (percentile rank > 78 % on the screening questionnaire FBB-ADHS-V)
Exclusion criteria: pervasive developmental disorder ; learning disability; children with poor knowledge of the German language; medical treatment of ADHD

Age minimum: 4 Years
Age maximum: 7 Years
Gender: All

Health Condition(s) or Problem(s) studied

F90
F98.8

F98.8

Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Hyperkinetic disorders

Intervention(s)

Group 1: Intervention B.A.S.E. ® - Babywatching (observation of a life-interaction between a mother and her baby): once per week; duration: 30 minutes; from october 2017 until july 2018
Group 2: Intervention: observation of mother-child-interaction on a videotape: one per week; duration: 30 minutes; from october 2017 until july 2018
Group 3: No intervention from october 2017 until july 2018

Primary Outcome(s)

ADHD symptoms (questionnaire FBB-ADHS-V (assessor is not blind)); Emotional competence (test ids-SEK (assessor is blind)). Two measure points: before and after the prevention program

Secondary Outcome(s)

Social Skills (questionnaire SSIS (assessor is not blind)); attachment (observation analysis GEV-B (assessor is blind)); Theory of Mind (test ToM-TB (assessor is blind)); Strengths and Difficulties SDQ (assessor is not blind)). Two measure points: before and after the prevention program

Secondary ID(s)

Source(s) of Monetary Support

Klinikum der Universität München, Dr. von Haunersches Kinderspital; Pädiatrische Psychosomatik und Psychotherapie

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 15/02/2017
Contact:

ethikkommission@med.uni-muenchen.de

Ethikkommission der Med. Fakultät der LMU

+49-89-440055191

ethikkommission@med.uni-muenchen.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00012834#studyResults

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