The ADHD Kids´ Study for Children 9-12 Years of Age (OutSmarters)

University of Iceland

Status: Not yet enrolling

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments: Behavioral: The Kid Counseling Program; Behavioral: The OutSMARTers Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07379359

94059 (Other Grant/Funding Number)

UI-2025-OutSMARTersADHDstudy

Details and patient eligibility

About

The aim of the study is to compare the efficacy of The OutSMARTers program- an ADHD skills training group program for children aged 9-12 to customized individual counseling provided by a professional, The Kid Counseling Program. Approximately 100 children will be randomly assigned to either intervention or a small wait-list group who will after a five-week-waiting period receive either intervention. Following the intervention, parents, children, and teachers will evaluate the effects on communication skills, well-being, and emotional regulation.

Full description

Attention-deficit hyperactivity disorder (ADHD) is an impairing neurodevelopmental disorder among children and adolescents that makes it difficult to cope with challenges of everyday life. Although various interventions have been developed to support parents of children with ADHD, few have been specifically designed for the children themselves, particularly interventions that focus directly on emotion regulation, problem-solving, communication and emotional well-being. The study is a randomized controlled trial (RCT) comparing the effectiveness of the OutSMARTers program, a skills-training group program based on cognitive- behavioral therapy (CBT) elements for children with ADHD. The program includes training in emotional regulation, social skills, self-control and problem-solving within a behavior modification framework. The comparison intervention, The Kid Counseling Program, consists of five sessions of individual counseling with similar content as in the OutSMARTers program, provided by a professional. The participants of this study will be approximately 100 children aged 9-12 that have been diagnosed with ADHD. Various methods will be used to assess outcomes, drawing on data from multiple sources through repeated measurements, including reports from parents, teachers, and the children themselves. The scientific goal of the study is to evaluate the efficacy of the OutSMARTers program, a group- based intervention delivered in 10 sessions over the course of 5 weeks, compared to brief individual counseling provided by a professional but not in a group of same-age peers. Positive changes in emotional regulation, communication skills, and well-being are expected in both groups. However, it is also possible that certain subgroups (e.g. children with or without comorbidities such as anxiety) may benefit more from one intervention over the other.

Enrollment: 100 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: 9-12
• have an ADHD diagnosis confirmed by a school psychologist
• children need to be fluent in Icelandic
• Parents need to be fluent in Icelandic or English

Exclusion criteria

• Children need to have an IQ of 70 or higher (WISC-IV test or WPSSI-R test)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

The OutSMARTers program

Experimental group

Description:

Child directed group skills training and cognitive-behavior therapy

Treatment:

Behavioral: The OutSMARTers Program

The Kid Counseling Program

Experimental group

Description:

Child directed individual sessions, skills training and cognitive-behavior therapy.

Treatment:

Behavioral: The Kid Counseling Program

Wait-list control group

No Intervention group

Description:

The Wait-list control group is assessed at pre and post (five week interval) and then receives either the OutSMARTers program or the Kid Counseling Program.