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

NCT02824796 | Completed

• 1 other identifier: 2015096
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dropout rate

  baseline, 12 weeks, 25 weeks

• Change from baseline in parent-teacher-rated Comorbidities symptoms

  baseline, 25 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Schema Parent Behavioral Training

EXPERIMENTAL

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

Behavioral: Schema Parent Behavioral Training

Parent Behavioral Training

ACTIVE COMPARATOR

Usually medication \& The usual PBT treatment

Behavioral: Parent Behavioral Training

Interventions

Schema Parent Behavioral Training BEHAVIORAL

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)

Schema Parent Behavioral Training

Parent Behavioral Training BEHAVIORAL

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

Parent Behavioral Training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assuta Hospital Systems: lead
• Tel Aviv University: collaborator

Study Sites (1)

Mental Health Children and Adolescent Clinic, Maccabi Health Services

Netanya, 42311, Israel

Location

Related Publications (2)

• 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.

  PMID: 22750360 BACKGROUND

• 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.

  PMID: 32996352 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 7, 2016
• Study Start: March 9, 2016
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: November 25, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)