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

ADHD Clinical Trial

— SPBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824796
• Other study ID #: 2015096
• Status: Completed
• Phase: N/A
• Start date: March 9, 2016
• Est. completion date: December 19, 2019

Study information

• Verified date: January 2020
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

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)
• Parent Behavioral Training
A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms

Locations

Country	Name	City	State
Israel	Mental Health Children and Adolescent Clinic, Maccabi Health Services	Netanya

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Hospital Systems	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in parent-teacher-rated ADHD symptoms	The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)	baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months
Secondary	Dropout rate	Group dropout rate during treatment	baseline, 12 weeks, 25 weeks
Secondary	Change from baseline in parent-teacher-rated Comorbidities symptoms	CBCL Internalizing score (Child Behavior Checklist)	baseline, 25 weeks, 3 months, 6 months, 12 months