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

November 23, 2020 updated by: Assuta Hospital Systems

Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel, 42311
        • Mental Health Children and Adolescent Clinic, Maccabi Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rate
Time Frame: baseline, 12 weeks, 25 weeks
Group dropout rate during treatment
baseline, 12 weeks, 25 weeks
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)
baseline, 25 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Hospital Systems

Collaborators

Tel Aviv University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2016

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 3, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ADHD

Clinical Trials on Schema Parent Behavioral Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe