The ADHD Kids´ Study for Children 9-12 Years of Age
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorUniversity of Iceland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Children need to have an IQ of 70 or higher (WISC-IV test or WPSSI-R test)
Trial design
Design model
Parallel
Treatments tested in this trial
The OutSMARTers Program
BehavioralAn 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 Program
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: The OutSMARTers programExperimental treatment 1 intervention
Group B: The Kid Counseling ProgramExperimental treatment 1 intervention
Group C: Wait-list control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, upon completion of 5 week program, at the 6 month follow-up2
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.
Time frame
Baseline, upon completion of 5 week program, 6 month follow-up3
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.
Time frame
Baseline, upon completion of 5 week program, 6 month follow-up4
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.
Time frame
Baseline, upon completion of 5 week program, 6 month follow-upSponsors and contacts
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Source ClinicalTrials.gov