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

Official title

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

Overview

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.

Interventions

• 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 progra
• 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

Primary outcome measures

• Strengths and difficulties questionnaire (SDQ) [Time frame: Baseline, upon completion of 5 week program, at the 6 month follow-up]
• Emotion Regulation Checklist (ERC) [Time frame: Baseline, upon completion of 5 week program, 6 month follow-up]
• ADHD Rating Scale (ADHD) [Time frame: Baseline, upon completion of 5 week program, 6 month follow-up]
• Revised Children's Anxiety and Depression Scale (RCADS) [Time frame: 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) [Time frame: Baseline, upon completion of 5 week program, 6 month follow-up]
• Social Skills Rating System (SSRS) [Time frame: Baseline, upon completion of 5 week program, 6 month follow-up]
• Treatment satisfaction [Time frame: Upon completion of 5 week program]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 24505061

Identifiers

NCT: NCT07379359 · UI-2025-OutSMARTersADHDstudy · 94059

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗