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Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach (SPBT)

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ClinicalTrials.gov Identifier: NCT02824796
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Assuta Hospital Systems

Brief Summary:
The purpose of this study is to determine whether a new parent training protocol for children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the comorbidities.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: Schema Parent Behavioral Training Behavioral: Parent Behavioral Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Treatment
Official Title: Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach: A Randomized Controlled Trial
Actual Study Start Date : March 9, 2016
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : December 19, 2019

Arm Intervention/treatment
Experimental: Schema Parent Behavioral Training
An enhanced protocol which combines a Schema Focused Therapy (SFT) and Behavioral Parent Training (PBT)
Behavioral: Schema Parent Behavioral Training
A novel protocol for parent whose children suffer from ADHD and comorbidities. The protocol combines elements from Schema Focus Therapy (SFT) and Parent Behavioral Training (PBT)

Active Comparator: Parent Behavioral Training
Usually medication & The usual PBT treatment
Behavioral: Parent Behavioral Training
A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms




Primary Outcome Measures :
  1. Change from baseline in parent-teacher-rated ADHD symptoms [ Time Frame: baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months ]
    The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)


Secondary Outcome Measures :
  1. Dropout rate [ Time Frame: baseline, 12 weeks, 25 weeks ]
    Group dropout rate during treatment

  2. Change from baseline in parent-teacher-rated Comorbidities symptoms [ Time Frame: baseline, 25 weeks, 3 months, 6 months, 12 months ]
    CBCL Internalizing score (Child Behavior Checklist)



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents to children 6-12 with ADHD symptoms according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V)
  • The child was diagnosed in the past as ADHD by MD

Exclusion Criteria:

  • Parents with psychotic symptoms or suicidality
  • Parents with active manic episode
  • Parents with substance dependence
  • Parents with autism spectrum disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824796


Locations
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Israel
Mental Health Children and Adolescent Clinic, Maccabi Health Services
Netanya, Israel, 42311
Sponsors and Collaborators
Assuta Hospital Systems
Tel Aviv University
Publications:
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Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT02824796    
Other Study ID Numbers: 2015096
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assuta Hospital Systems:
ADHD