Psychologenpraktijk Kuin
Haarlem, Netherlands
Location status: Recruiting
NCT Number: NCT07504107
The goal of this clinical trial is to learn whether the ADHD&me (ADHD&ik) intervention can improve self-esteem in youth aged 16-25 years with Attention Deficit Hyperactivity Disorder (ADHD). The ADHD&me program is a cognitive behavioral therapy (CBT)-based intervention designed to help people with ADHD to develop a more positive view of themselves in their transition to adulthood.
The main questions it aims to answer are:
* Does the ADHD&me intervention improve self-esteem in youth with ADHD, and are these effects maintained over time? * Does the intervention also improve related outcomes, such as masking of ADHD-related behaviors and co-occurring mental health symptoms including anxiety, depression, and stress?
In this RCT, participants are assigned either to immediate treatment or to a waitlist control condition, with the latter receiving the intervention after an eight-week delay.
Participants will:
* Take part in seven individual therapy sessions according to the ADHD&me intervention. * Complete questionnaires about self-esteem, masking of ADHD-related behaviors, ADHD symptoms, and co-ccurring mental health symptoms at several time points. * Complete short daily assessments (ecological momentary assessment) during one week at the start of the study and one week after the intervention or waitlist period to report momentary self-esteem, emotions, distress, and activities.
Interested in participating?
Request Info16 year–25 year
All sexes
Interventional
Not applicable
Haarlem, Netherlands
Location status: Recruiting
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental condition characterized by symptoms of inattention, impulsivity, and hyperactivity that may lead to impairments across multiple life domains. Although ADHD is often diagnosed in childhood, symptoms frequently persist into adulthood. Emerging adulthood is a developmental stage characterized by increasing independence and responsibilities related to education, work, and social relationships. For individuals with ADHD, these demands may intensify existing difficulties with attention regulation, organization, and time management. In addition to the core symptoms of ADHD, many individuals experience mental health difficulties such as anxiety, depression, and stress, which can further complicate daily functioning. These challenges highlight the importance of interventions that address not only ADHD symptoms but also broader psychological factors that influence functioning.
Low self-esteem is considered an important factor that may contribute to these difficulties. Throughout their lives, individuals with ADHD often encounter repeated experiences of failure, criticism, or negative feedback in academic, occupational, or social contexts. Over time, these experiences may lead to negative self-evaluations and reduced self-esteem. Low self-esteem may in turn exacerbate ADHD-related impairments and psychological distress, contributing to a negative cycle in which ADHD symptoms, stress, and comorbid mental health difficulties reinforce each other. Despite the importance of self-esteem for psychological functioning, many existing ADHD treatments primarily focus on reducing ADHD symptoms through skills training and may pay limited attention to self-esteem and masking. The aim of this study is therefore to evaluate whether the ADHD&me intervention improves self-esteem in emerging adults with ADHD and whether these effects are associated with changes in related psychological outcomes.
The ADHD&me (ADHD&ik) intervention was developed to address this gap by specifically targeting self-esteem in emerging adults with ADHD. The intervention consists of seven individual therapy sessions and aims to strengthen self-esteem by addressing negative self-evaluations and masking behavior and by supporting participants in developing a more adaptive relationship with their ADHD. A pilot study was conducted, and the intervention protocol was refined through an iterative process based on its findings.
The effectiveness of the ADHD&me intervention will be evaluated using a multicenter randomized controlled trial. Emerging adults with ADHD and low self-esteem will be randomly assigned in a 1:1 ratio to either (1) an immediate intervention group with two-month follow-up assessment or (2) a waitlist control condition receiving the intervention after an eight-week delay. Randomization will be performed using stratified block randomization based on ADHD medication use (yes/no), gender (male/female), and age group (16-20/21-25).
The primary outcome of the study is self-esteem. Secondary outcomes include masking of ADHD-related behaviors, ADHD symptoms, anxiety symptoms, depressive symptoms, perceived stress, executive functioning, rejection sensitivity, and quality of life. In addition to questionnaire assessments, ecological momentary assessment (EMA) will be used to examine fluctuations in self-esteem, emotions, and distress in daily life. Additional measures will assess treatment-related factors such as therapeutic alliance, client satisfaction, and treatment integrity to evaluate the quality of intervention delivery and therapists/participants' experiences.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note. If included participants receive unforeseen supportive sessions outside the research setting, or if unforeseen medication changes occur during the study, these will be documented and considered during the analysis.
The ADHD&me (ADHD&ik) intervention is a cognitive behavioral therapy (CBT)-based program designed to improve self-esteem in emerging adults (aged 16-25 years) with ADHD and low self-esteem. The intervention consists of seven individual therapy sessions of approximately 45-60 minutes delivered by trained therapists. The program combines psychoeducation, cognitive and behavioral exercises to help participants understand the interaction between ADHD, stress, and self-beliefs. Core components include identifying negative self-beliefs and masking behaviours, strengthening positive self-representations through positive memories and personal strengths, and examining and modifying person-environment interactions. Sessions follow a structured workbook-based format and include exercises, goal setting, and between-session practice assignments to support the development of a more positive self-esteem.
Other names: ADHD&ik
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES), a 10-item self-report questionnaire measuring global self-worth and positive and negative beliefs about the self. Items are rated on a four-point Likert scale, with higher scores indicating higher levels of self-esteem.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Masking of ADHD-related behavior will be assessed using the MAT-Q, measuring the extent to which individuals hide, compensate for, or suppress ADHD-related behavior in social, academic, or performance-related contexts. This questionnaire has yet to be validated.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Depressive symptoms will be assessed using the depression subscale of the DASS-42 (14 items) scored on a 4-point scale; items are summed into a depression subscale score.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Social anxiety symptoms will be assessed with the Dutch LSAS (24 items). Each item is scored twice (fear and avoidance) on a 4-point scale; scores are summed into a total score and subscale scores.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Fear of negative evaluation will be assessed with the Dutch Brief FNE (12 items) scored on a 5-point scale; scores are summed into a total score. An additional item is included: "Do you believe you receive more/fewer negative evaluations compared to others?"
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Fear of positive evaluation will be assessed with the FPES (10 items) scored on a 0-9 scale; scores are summed into a total score. An additional item is included: "Do you believe you receive more/fewer positive evaluations compared to others?"
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Perceived stress will be assessed using a translated Dutch version of the PSQ (30 items), scored on a 4-point scale reflecting how often it applied during the last month. Items are summed into a total score.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Rejection sensitivity will be assessed using a translated Dutch ARSQ (9 items) with ratings of rejection concern and rejection expectation. Total rejection sensitivity is calculated as the mean of item-level rejection sensitivity scores. An additional item is included: "Do you believe you are rejected more/less compared to others?"
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
ADHD symptoms will be assessed using the "Self-report questionnaire on attention problems and hyperactivity". The questionnaire includes 23 items scored on a 4-point scale. At baseline (T0) items are scored for adulthood and retrospectively for childhood; at T1 and T2 items are scored for adulthood only. Scores are summed into a total score.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention/post-waitlist), and week 18 (two-month follow-up or post-intervention; T2).
Executive functioning will be assessed with the Dutch BRIEF-A (75 items; 9 subscales). Items are scored on a 3-point scale. Scores are summarized into the Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC), plus subscales.
Time frame: Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.
Quality of life will be assessed with the Dutch MHQoL (8 items). The first 7 items cover dimensions of quality of life (4 response levels); the final item assesses general psychological well-being on a 0-10 visual analogue scale.
Time frame: One week before the intervention/waitlist control period and one week after the intervention/waitlist control period (i.e., after T0 and after T1).
Ecological momentary assessment (EMA) will be used to assess self-esteem in daily life, emotions (multiple choice), activity (multiple choice), and distress (0-100) using the Subjective Units of Distress Scale (SUDS). Data will be collected via the mPath smartphone app. Participants receive 8 prompts per day; each prompt consists of 4 short questions including a 0-100 self-esteem item ("How satisfied are you with yourself right now?").
Contact information is provided by the study sponsor or research team.
Universiteit Leiden
Other
ADHD&me: a Randomized Controlled Trial to Target Self-esteem in Youth With ADHD
Acronym: ADHD&me
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06081348
22Q11 Deletion, 22q11 Deletion Syndrome
Calgary, Alberta, Canada
View Trial DetailsNCT07717879
ADHD, Attention Deficit Disorder with Hyperactivity
Dothan, Alabama, United States
View Trial DetailsNCT07717892
ADHD, Attention Deficit Disorder with Hyperactivity
Dothan, Alabama, United States
View Trial DetailsNCT06284655
ADHD, Attention Deficit Disorder with Hyperactivity
Trondheim, Norway
View Trial Details