Trial document




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  DRKS00009709

Trial Description

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Title

Differential Impact of Parental Participation on Intensified Exposure Based Psychological Interventions in Anxiety Disorders in Children.

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Trial Acronym

PEACH

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URL of the Trial

http://www.kiba-studie.de

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Brief Summary in Lay Language

The project focuses on the treatment of children with anxiety disorders. Psychotherapy centers in six German Universities (Bochum, Dresden, Marburg, Koblenz-Landau, Freiburg and Würzburg) will investigate how psychotherapy can be improved, in order to most effectively help children with anxiety disorder and their parents. The study examines whether parental participation in children's psychotherapy is more effective than in a treatment focussing only on the child. Children with social anxiety, separation anxiety, or specific phobias (age:8-16 years) are invited to participate. After a thorough diagnostic assessment the child is randomly assigned to one of two psychotherapy conditions. In both conditions the child will receive cognitive behavioral therapy a treatment that has been shown as successful in many studies. In one condition the therapy will be conducted with the child only, while in the other condition the parents are being included into the treatment sessions. The results of the study will give important information on the role of active parental participation in the treatment of childhood anxiety disorders.

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Brief Summary in Scientific Language

In sharp contrast to adult Ads, childhood AD (CAD) are under-researched in spite of their high prevalence,
strong continuity into adulthood and powerful prediction of adult disorders. Moreover, existing
studies show poorer treatment outcomes in CAD and have lacked the statistical power to investigate
disorder- and age-specific effects. Basic research indicates that suboptimal conditions for extinction
learning and context conditioning with the parents as powerful context variable (specific to children
and differentially relevant to SepAD vs. other CAD) could explain poorer extinction learning and
higher return of fear in children. Conceptualizing exposure as extinction learning and parents as a
highly relevant learning context for children, we will administer high doses of extinction trials in biweekly
double sessions with (IPI/P+) vs. without (IPI/P-) parental participation to examine the disorder-
specific efficacy of parental participation aiming to improve the outcome of CAD treatment. Primary hypotheses: (1) IPI/P+ will be superior to IPI/P- in primary outcome measures at follow-up for SepAD, but not for SP and SAD. (2) In both treatment conditions the active treatment phase will yield superior outcomes compared to the no-treatment baseline phase on primary and secondary outcome measures at post and follow-up assessments. Secondary hypotheses: 3) Parental participation (IPI/P+) is expected to have stronger effects in younger patients. (4) IPI/P+ will result in more pronounced changes in behavioral proxy measures of extinction learning (see P3, P5) in SepAD but not in SP and SAD. (5) Furthermore, we will explore transgenerational effects and test the hypothesis that child interventions improve parental psychopathology. With its associated mechanistic components, the proposed study will contribute to a better identification of core ingredients and optimal ways of delivering anxiety treatment in children which can be expected to reveal substantial longterm benefits (reduced burden in children and their families, prevention of secondary mental disorders).
Ammendment, June 1st, 2018: The inclusion criteria regarding the age were changed from 8-14 to 8-16 years to ensure reaching the recruitment goals. Additionally this makes it possible to recruit adolescents from the adult trial (PROTECT AD- P1), because the project is almost finished.

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Organizational Data

  •   DRKS00009709
  •   2015/12/04
  •   [---]*
  •   yes
  •   Approved
  •   SS 012015, Deutsche Gesellschaft für Psychologie (DGPs)
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   DSM-5: 300.23 Social Anxiety Disorder
  •   DSM-5: 300.29 Specific Phobia
  •   DSM-5: 309.21 Seperation Anxiety Disorder
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Interventions/Observational Groups

  •   Intensified exposure based therapy for children with anxiety disorders with parental participation (session 1-4 and 9-11 à 50 min., session 5-8 à 100 min. over a timespan of 7 weeks (2 sessions a week/week 1-4; 1 session a week/week 5-7)
  •   Intensified exposure based therapy for children with anxiety disorders without parental participation (session 1-4 and 9-11 à 50 min., session 5-8 à 100 min. over a timespan of 7 weeks (2 sessions a week/week 1-4; 1 session a week/week 5-7)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Multi-informant approach (children, parents, clinican)

Kinder-DIPS: Diagnosis and rating of degree of severity.
Assessement is conducted pre therapy, post therapy (online diagnosis which were fulfilled pre therapy), 6-months follow-up

CGI (Clinical Global Impression Scale): Global clinical impression/ severity of symptoms
BEE/BEL (Sheehan Disability Scale): Impairment/ Disability
AASC-C (Anxiety and Avoidance Scale for Childhood Anxiety Situations): Anxiety and Avoidance in specific situations
Assessement is conducted pre therapy, throughout therapy (each session), post therapy and 6-months follow-up.
LSAS-CA-SR (Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA)- Self-report
SAAI - C/P (Seperation Anxiety and Avoidance Inventory): Seperation Anxiety Disorder
Assessement is conducted pre therapy, throughout therapy (at three points), post therapy and 6-months follow-up.

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Secondary Outcome

Multi-informant approach (parents and children)

Assessment points:
Pre therapy (BL),
post therapy post),
6-monthfollow-up (fu),
throughout therapy (i),
each session (es)

diagnosis-specific symptoms:
SCAS (Spence`s Children`s Anxiety Scale) : anxiety (BL, post und fu)

overaching symptoms:
SDQ (Strenghts and Diffilcuties Questionnaire): (BL, post und fu)
SMFQ (Short Mood and Feelings Questionnaire) : (BL, post und fu)

Impairment and quality of life:
ILK (Inventar zur Erfassung der Lebenqualität bei Kindern und Jugendlichen): quality of life (BL, post und fu)
WIRK-ALL (Selbstwirksamkeit): self efficacy (BL, i, post und fu)

Parenting style:
OP (Overprotection): (parents only) (BL, post und fu)
PPS-Q: granted autonomy (children only) (BL, post und fu)

Parental psychopathology/cognitions (parents only):
BDI-II (Beck's Depression Inventory): depression (BL, post und fu)
DSM AG (DSM Agoraphobia): DSM-5 Scale Agoraphobia (BL, post und fu)
DSM GAS (DSM Generalized Anxiety Disorder): DSM-5 Scale Generalized Anxiety Disorder (BL, post und fu)
DSM PS (DSM Panic Disorder) : DSM-5 Scale Panic Disorder (BL, post und fu)
DSM SAD (DSM Social Anxiety Disorder): DSM-5 Scale Social Anxiety Disorder (BL, post und fu)
DSM SP (DSM Specific Phobia): DSM-5 Scale Specific Phobia (BL, post und fu)
DSM SepAD (DSM Seperation Anxiety Disorder): DSM-5 Scale Seperation Anxiety Disorder (BL, post und fu)
PBA-Q (Parental Beliefs about Anxiety Questionnaire) Parental anxiety cognitions (BL, i, post und fu)
SCL-K-9 (Kurzform der Symptomcheckliste SCL-90-R): parental psychopathology (BL, post und fu)
PFB-K (Partnerschaftsfragebogen Kurzform): parental satisfaction with their partnership (BL, post und fu)

Process variables:
Exposition protocol (children only): standardized exposition protocol during the sessions (es, post und fu)
Exposition protocol (children only): standardized exposition protocol between the sessions (es, post und fu)

INEP (Inventar zur Erfassung Negativer Effekte von Psychotherapie) negative effects of psychoterhapy (post)
NWPT -K/E (Nebenwirkungen von Psychotherapie bei Kindern): possible side effects of psychotherapy for children (i)

Satisfaction with the intervention (post und fu)
Belief in the intervention’s rational (i)

Therapist:
FBB-T (Fragebogen zur Beurteilung der Behandlung): Evaluation of each session (es)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2015/12/09
  •   359
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   16   Years
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Additional Inclusion Criteria

1. Age between 8 and 16 years
2. Fullfillment of DSM-V-criteria for separation anxiety disorder, social anxiety disorder or specific phobia as a primary diagnosis (secondary comorbid disorders allowed)
3. Kinder-DIPS degree of severity >=4
4. Knowledge of the german language
5. Availability of at least one parent, informed consent of both parents of the child

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Exclusion Criteria

1. Primary mental disorder other than separation anxiety, social anxiety disorder or specific phobia.
2. unstable psychotropic medication or simultanious psychotherapy
3. Acute suicidality
4. General medical contraindication

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Addresses

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    • Fakultät für Psychologie, Arbeitseinheit für Kinder- und Jugendpsychologie, Ruhr-Universitätbochum
    • Ms.  Professor  Silvia  Schneider 
    • Massenbergstraße 9-13
    • 44787  Bochum
    • Germany
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    • Institut für klinische Psychologie und Psychotherapie
    • Chemnitzer Straße 46
    • 01187  Dresden
    • Germany
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    • Kinder- und Jugendlichen-Psychotherapie-Ambulanz Marburg (KJ-PAM)
    • Frankfurter Str. 35
    • 35037  Marburg
    • Germany
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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Würzburg
    • Füchsleinstraße 15
    • 97080  Würzburg
    • Germany
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    • Landauer Psychotherapie-Ambulanz für Kinder und Jugendliche
    • Ostbahnstr. 12.
    • 76829  Landau
    • Germany
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    • Psychotherapeutischen Ambulanz für Kinder, Jugendliche und Familien Freiburg
    • Engelbergerstraße 41
    • 79106  Freiburg
    • Germany
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    • Fakultät für Psychologie, Arbeitseinheit für Kinder- und Jugendpsychologie, Ruhr-Universität Bochum
    • Ms.  Professor  Silvia  Schneider 
    • Massenbergstraße 9-13
    • 44787  Bochum
    • Germany
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    • Zentrum für Kinder- und Jugendlichenpsychotherapie am Forschungs- und Behandlungszentrum für psychische Gesundheit der Ruhr-Universität Bochum
    • Ms.  M.Sc.  Verena  Pflug 
    • Massenbergstraße 9-13
    • 44787  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.