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

NCT07379359 | Not Yet Recruiting

• 2 other identifiers: UI-2025-OutSMARTersADHDstudy94059
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

Intervention program for ADHD; Children; OutSMARTers Program; Skill building; Cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

The OutSMARTers program

EXPERIMENTAL

Child directed group skills training and cognitive-behavior therapy

Behavioral: The OutSMARTers Program

The Kid Counseling Program

EXPERIMENTAL

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

Behavioral: The Kid Counseling Program

Wait-list control group

NO INTERVENTION

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.

Interventions

The OutSMARTers Program BEHAVIORAL

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).

The OutSMARTers program

The Kid Counseling Program BEHAVIORAL

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.

The Kid Counseling Program

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iceland: lead

Related Publications (1)

• 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.

  PMID: 24505061 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dagmar Kr Hannesdottir, PhD

CONTACT

+354 525 4351; dkh@hi.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Teachers of the enrolled children will be completing assessments before and after the interventions and will be blind to the treatment / wait list allocation of the child they are reporting on.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Psychology

Model Details: The proposed study is an RCT with a three-group parallel design. The children will be randomly assigned to three groups using a 2:2:1 ratio: 1) The OutSMARTers program (n = 40), 2) The Kid Counseling Program (n = 40) or 3) A wait-list control group (n = 20), which will receive the OutSMARTers program or the Kid Counseling Program once the waiting period (5 weeks) is over.

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: January 30, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share