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

The ADHD Kids´ Study: Randomized Clinical Trial on the OutSMARTers Program and Individual Counseling for Children Aged 9-12 With ADHD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Behavioral: The OutSMARTers Program; Behavioral: The Kid Counseling Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dagmar Kr Hannesdottir, PhD; Phone Number: +354 525 4351; Email: dkh@hi.is

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The OutSMARTers program; Child directed group skills training and cognitive-behavior therapy	Behavioral: The OutSMARTers Program; An intervention specifically designed to improve common difficulties that children with ADHD wrestle with daily. The program consists of ten sessions (90 minutes each) conducted by two or three trainers working with a group of six children over the course of five weeks. The children attend four different stations during the intervention: the Emotion station and the Friendship station in sessions one through five, and the Stopping station and the Solution station in the remaining five. The program is fully manualized and was published in Icelandic in 2017 (Hannesdottir et al., 2017b). A small RCT pilot study of the OutSMARTers program delivered in a clinical setting showed beneficial effects on emotion regulation skills, social skills and a reduction in ADHD symptoms as rated by parents (Hannesdottir et al., 2017a).
Experimental: The Kid Counseling Program; Child directed individual sessions, skills training and cognitive-behavior therapy.	Behavioral: The Kid Counseling Program; The Kid Counseling Program consists of five 50-minute individual counseling sessions, each delivered by a professional, and based on the book Learning to Slow Down and Pay Attention (Nadeau & Dixon, 2004). The content closely mirrors that of the OutSMARTers program and shares the same goal; to improve common deficits that children with ADHD face. The key difference is that, unlike the OutSMARTers program, this intervention is individualized and does not include peer-based practice of the skills learned.
No Intervention: Wait-list control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strengths and difficulties questionnaire (SDQ)	SDQ assess behavior and well-being in children generally based on the following factors: emotional problems, behavioral problems, hyperactivity, social difficulties, and social competence. Each item is scored on a 0-2-point Likert scale, where higher scores indicate more difficulties, except on the social competence factor. Higher scores on the social competence factor indicate better social competence.	Baseline, upon completion of 5 week program, at the 6 month follow-up
Emotion Regulation Checklist (ERC)	The ERC measures emotion regulation among youth. Parents and teachers complete this questionnaire regarding the child's emotional regulation and negative mood. The scale consists of 24 questions and has been validated in the general Icelandic population. Each item is scored on a 1-4 Likert Scale. Higher scores on the Lability/Negativity factor indicate more dysregulation and difficulties. while higher scores on the Emotion Regulation factor indicate better emotion regulation skills.	Baseline, upon completion of 5 week program, 6 month follow-up
ADHD Rating Scale (ADHD)	The ADHD scale assesses symptoms and impairment of attention-deficit/hyperactivity disorder, i.e. difficulties with concentration and hyperactive behavior. These symptoms align with the diagnostic criteria of the DSM classification system. Each item is scored on a 0-3 Likert Scale where higher scores indicate more ADHD symptoms. Responses from parents and teachers are compared to the norms of Icelandic children.	Baseline, upon completion of 5 week program, 6 month follow-up
Revised Children's Anxiety and Depression Scale (RCADS)	The RCADS is a commonly used questionnaire to screen for anxiety and depressive disorders and to assess changes following an intervention. The RCADS is a 47-item questionnaire designed for parents and children (ages 8-17) and includes the following scales: Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, and Depressive Symptoms. Items are rated on a four-point scale: 0 = never, 1 = sometimes, 2 = often, 3 = always. Higher scores indicate more anxiety and depressive symptoms. The Icelandic version has acceptable psychometric properties in both general and clinical populations.	Baseline, upon completion of 5 week program, 6 month follow-up
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents-Revised Version (KINDL-R)	Parents and children are asked to evaluate how well the child has been doing and feeling recently in terms of physical health, emotional well-being, self-esteem, family relationships, peer relationships, and school (Ravens-Sieberer & Bullinger, 1998 - see www.kindl.org). Each item is scores on a Likert scale of 1-5 and higher scores indicate better quality of life for each factor.	Baseline, upon completion of 5 week program, 6 month follow-up
Social Skills Rating System (SSRS)	Children complete an assessment on their social skills. The questionnaire assesses Cooperation, Assertion, Self-control and Responsibility. Items are scored on a 0-2 Likert scale where higher scores on each factor indicates better skills.	Baseline, upon completion of 5 week program, 6 month follow-up
Treatment satisfaction	Parents and children complete questions on treatment satisfaction. The questions include some open comments, but most items are scored on a scale of 1-4, with higher ratings indicating more satisfaction.	Upon completion of 5 week program

Collaborators and Investigators

• Sponsor: University of Iceland

Publications and helpful links

General Publications

• Hannesdottir DK, Ingvarsdottir E, Bjornsson A. The OutSMARTers Program for Children With ADHD. J Atten Disord. 2017 Feb;21(4):353-364. doi: 10.1177/1087054713520617. Epub 2016 Jul 28.

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: September 27, 2025
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Cognitive-behavioral therapy; Skill building; Intervention program for ADHD; OutSMARTers Program
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: UI-2025-OutSMARTersADHDstudy; 94059 (Other Grant/Funding Number: University of Iceland Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As the study includes repeated measures of a clinical child population, parts of the data will be classified as sensitive personal data and thus restricted by the permit from the National Bioethics Committee of Iceland.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No