Clinical trial Recruiting at 1 site Interventional Ages 9 to 12

OutSMARTers program for kids with ADHD ages 9–12

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

Run by University of Iceland · NCT07379359 · Data updated 2026-11-12

This trial tests whether a group skills program called OutSMARTers helps 9–12 year-olds with ADHD compare to five weeks of individual counseling to see which improves communication, well-being, and emotional regulation.

Quick facts

Study typeInterventional
Ages9 Years to 12 Years
SexAll
Enrollment100 (estimated)
SponsorUniversity of Iceland
Academic / other
Locations1 site (Reykjavik)
StatusRecruiting
StartedJune 2, 2026
Main results expectedOctober 1, 2028
Study endsOctober 1, 2029
Registry record updatedAugust 26, 2026
Trial IDNCT07379359 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 9-12 with a confirmed ADHD diagnosis, fluent in Icelandic, and with IQ 70 or higher.

Probably not a fit

Children without a confirmed ADHD diagnosis, or those not meeting language or cognitive criteria, may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares the OutSMARTers program, a CBT-based group skills training delivered over 10 sessions in 5 weeks, with five sessions of individual counseling (Kid Counseling Program) for children with ADHD aged 9–12. Approximately 100 participants will be randomized to either the OutSMARTers group or a wait-list control that receives the alternative intervention after a five-week delay. Outcomes will be measured using reports from parents, teachers, and the children themselves to assess communication skills, well-being, and emotional regulation. The study is conducted at the University of Iceland and associated centers, with eligibility requiring an ADHD diagnosis, fluency in Icelandic, and cognitive ability sufficient to participate. The aim is to determine whether a child-focused CBT skills program provides greater benefit than individualized counseling for core ADHD-related challenges.

Why it matters

Potential benefit: If successful, the OutSMARTers program could provide a more effective, scalable approach to improving emotional regulation and social skills for children with ADHD.

How similar studies have gone: Previous work suggests that CBT-based group interventions can help with emotional regulation and social skills in ADHD, but direct evidence in this age range with this specific program is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Children´s Mental Health Center / University of Iceland
    Reykjavik, Iceland
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.