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

Primary Purpose

ADHD

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Schema Parent Behavioral Training
Parent Behavioral Training
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Children and Adolescent Clinic, Maccabi Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Schema Parent Behavioral Training

Parent Behavioral Training

Arm Description

An enhanced protocol which combines a Schema Focused Therapy (SFT) and Behavioral Parent Training (PBT)

Usually medication & The usual PBT treatment

Outcomes

Primary Outcome Measures

Change from baseline in parent-teacher-rated ADHD symptoms
The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)

Secondary Outcome Measures

Dropout rate
Group dropout rate during treatment
Change from baseline in parent-teacher-rated Comorbidities symptoms
CBCL Internalizing score (Child Behavior Checklist)

Full Information

First Posted
June 29, 2016
Last Updated
November 23, 2020
Sponsor
Assuta Hospital Systems
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT02824796
Brief Title
Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach
Acronym
SPBT
Official Title
Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2016 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assuta Hospital Systems
Collaborators
Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schema Parent Behavioral Training
Arm Type
Experimental
Arm Description
An enhanced protocol which combines a Schema Focused Therapy (SFT) and Behavioral Parent Training (PBT)
Arm Title
Parent Behavioral Training
Arm Type
Active Comparator
Arm Description
Usually medication & The usual PBT treatment
Intervention Type
Behavioral
Intervention Name(s)
Schema Parent Behavioral Training
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Parent Behavioral Training
Intervention Description
A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms
Primary Outcome Measure Information:
Title
Change from baseline in parent-teacher-rated ADHD symptoms
Description
The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)
Time Frame
baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Dropout rate
Description
Group dropout rate during treatment
Time Frame
baseline, 12 weeks, 25 weeks
Title
Change from baseline in parent-teacher-rated Comorbidities symptoms
Description
CBCL Internalizing score (Child Behavior Checklist)
Time Frame
baseline, 25 weeks, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mental Health Children and Adolescent Clinic, Maccabi Health Services
City
Netanya
ZIP/Postal Code
42311
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22750360
Citation
Lee PC, Niew WI, Yang HJ, Chen VC, Lin KC. A meta-analysis of behavioral parent training for children with attention deficit hyperactivity disorder. Res Dev Disabil. 2012 Nov-Dec;33(6):2040-9. doi: 10.1016/j.ridd.2012.05.011. Epub 2012 Jun 29.
Results Reference
background
PubMed Identifier
32996352
Citation
Solan M, Brunstein Klomek A, Ankori G, Bloch A, Apter A, Plishty S. Impact of a New Parent Behavioral-Schema Training on Children with ADHD: A Pragmatic Control Trial. J Atten Disord. 2021 Dec;25(14):2048-2059. doi: 10.1177/1087054720959711. Epub 2020 Sep 30.
Results Reference
derived

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

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