Attention-Deficit/Hyperactivity Disorder (ADHD)OutSmartersNCT07379359
The ADHD Kids´ Study for Children 9-12 Years of Age
A study testing The OutSMARTers Program and The Kid Counseling Program in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by University of Iceland at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- The OutSMARTers Program and The Kid Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIceland
- Study dates
- 2 Jun 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children need to have an IQ of 70 or higher (WISC-IV test or WPSSI-R test)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Children´s Mental Health Center / University of Iceland
Reykjavik, 108
Dagmar Kr. Hannesdottir, PhD, +354 513 6600, dkh@hi.is
About this study
Official title: 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.
Read the 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.
- Being tested
- The OutSMARTers Program, The Kid Counseling Program
- Keywords
- Intervention program for ADHD, Children, OutSMARTers Program, Skill building, Cognitive-behavioral therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The OutSMARTers ProgramBehavioural
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 Kid Counseling ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The OutSMARTers program | Experimental | Child directed group skills training and cognitive-behavior therapy Receives: Behavioral: The OutSMARTers Program |
| The Kid Counseling Program | Experimental | Child directed individual sessions, skills training and cognitive-behavior therapy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Upon completion of 5 week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start2 Jun 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dagmar Kristín Hannesdóttir, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379359
- Sponsor's protocol ID
- UI-2025-OutSMARTersADHDstudy
- Other IDs
- 94059
- Acronym
- OutSmarters
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 24505061
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ADHD Kids´ Study: Randomized Clinical Trial on the OutSMARTers Program and Individual Counseling for Children Aged 9-12 With ADHD
- ClinicalTrials.gov ID
- NCT07379359
- Acronym / sponsor ID
- OutSmarters / UI-2025-OutSMARTersADHDstudy
- Keywords
- Intervention program for ADHD, Children, OutSMARTers Program, Skill building, Cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The OutSMARTers program | Experimental | Behavioral: The OutSMARTers ProgramChild directed group skills training and cognitive-behavior therapy |
| The Kid Counseling Program | Experimental | Behavioral: The Kid Counseling ProgramChild directed individual sessions, skills training and cognitive-behavior therapy. |
| 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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Children need to have an IQ of 70 or higher (WISC-IV test or WPSSI-R test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The OutSMARTers ProgramAn 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). | Behavioural | The OutSMARTers program |
| The Kid Counseling ProgramThe 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. | Behavioural | The Kid Counseling Program |
Primary outcome
Strengths and difficulties questionnaire (SDQ)
Time frame: Baseline, upon completion of 5 week program, at the 6 month follow-up
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.
Emotion Regulation Checklist (ERC)
Time frame: Baseline, upon completion of 5 week program, 6 month follow-up
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.
ADHD Rating Scale (ADHD)
Time frame: Baseline, upon completion of 5 week program, 6 month follow-up
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.
Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: Baseline, upon completion of 5 week program, 6 month follow-up
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.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents-Revised Version (KINDL-R)
Time frame: Baseline, upon completion of 5 week program, 6 month follow-up
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.
Social Skills Rating System (SSRS)
Time frame: Baseline, upon completion of 5 week program, 6 month follow-up
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.
Treatment satisfaction
Time frame: Upon completion of 5 week program
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 24505061Hannesdottir 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The OutSMARTers Program and The Kid Counseling Program in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by University of Iceland at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dagmar Kr Hannesdottir, PhD (+354 525 4351, dkh@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and difficulties questionnaire (SDQ) (time frame: Baseline, upon completion of 5 week program, at the 6 month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07379359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.