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| Name | Class |
|---|---|
| Leids Universiteits Fonds | UNKNOWN |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants receive the CBT-based ADHD&me intervention immediately after randomization (7 weekly individual sessions) and have a follow-up assessment two months after treatment |
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| Waitlist-control (delayed intervention) | Other | Participants are assigned to a waitlist and receive the intervention after an 8-week delay. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADHD&me | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Esteem (Rosenberg Self-Esteem Scale; RSES) | 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. | Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Masking of ADHD-Related Behavior (MAT-Q) | 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. | Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Momentary self-esteem, distress, emotions, and activity | 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?"). |
Inclusion Criteria:
16-25 years old.
Official ADHD diagnosis, that is confirmed by research team using the clinical interview MINI-S.
Low self-esteem, determined through a structured and multi-step procedure to minimize subjectivity:
Pharmacological treatment for ADHD is allowed, but medication dose should be stabilized for a minimum of 4 weeks at baseline measurement (T0). Although changes in ADHD medication during the study are not preferred, they may occur in practice. Any such changed will be carefully documented.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bianca Boyer | Contact | +31 71 5272727 | b.e.boyer@fsw.leidenuniv.nl | |
| Jasmin Rahemenia | Contact | j.rahemenia@fsw.leidenuniv.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychologenpraktijk Kuin | Recruiting | Haarlem | Netherlands |
De-identified individual participant data (IPD) underlying the results reported in publications may be shared after completion of the PhD project and after publication of the (primary) study results. Data sharing will only take place with permission of the principal investigator and in accordance with participant consent, applicable privacy regulations (GDPR), and institutional data management policies. Data will be shared in coded form for scientific research purposes only and may require a data sharing agreement. Requests for access to the data can be submitted to the principal investigator.
Individual participant data and supporting materials will become available after publication of the (primary) study results and completion of the PhD project. Data will be available upon reasonable request for scientific research purposes, subject to approval by the principal investigator and in accordance with participant consent and applicable privacy regulations. Data will remain available for up to 15 years after completion of the study.
Access to de-identified individual participant data (IPD) and supporting information will be granted to researchers for scientific research purposes. Data will include the de-identified dataset underlying the results reported in publications, as well as the study protocol and statistical analysis plan.
Requests for access to the data can be submitted to the principal investigator. Data access will be granted after approval by the principal investigator and in accordance with participant consent, applicable privacy regulations (GDPR), and institutional data management policies. Data may be shared under a data sharing agreement.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Participants will be randomly assigned to one of two conditions: an immediate intervention group or a waitlist control group. Participants in the immediate intervention group will start the ADHD&me intervention directly after baseline assessment (T0). Participants in the waitlist control group will wait for eight weeks before starting the intervention.
Both groups complete assessments at baseline (T0) and after the first study period (T1). Participants in the immediate intervention group then complete a follow-up assessment two months after the final intervention session (T2). Participants in the waitlist control group start the intervention after T1 and complete T2 after finishing the intervention. This delayed treatment design allows comparison between participants who receive the intervention and participants who are waiting to receive the intervention.
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Participants, therapists, and researchers are not blinded to treatment allocation due to the nature of the psychological intervention and the delayed treatment (waitlist) design. Randomization is conducted by an independent researcher who is not involved in treatment delivery or outcome assessments in order to minimize allocation bias.
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| Depressive symptoms (Depression subscale of the DASS-42) | 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. | 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 (Liebowitz Social Anxiety Scale; LSAS) | 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. | 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 (Brief Fear of Negative Evaluation; FNE) | 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?" | 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 (Fear of Positive Evaluation Scale; FPES) | 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?" | 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 (Perceived Stress Questionnaire; PSQ) | 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. | 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 (Adult Rejection Sensitivity Questionnaire; ARSQ) | 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?" | 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 (Self-report questionnaire on attention problems and hyperactivity; Kooij & Buitelaar, 1997) | 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. | Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention. |
| Executive functioning (Behavior Rating Inventory of Executive Function - Adult Version; BRIEF-A) | 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. | Week 0 (T0; baseline), week 9 (T1; post-intervention/post-waitlist), and week 18 (two-month follow-up or post-intervention; T2). |
| Quality of life (Mental Health Quality of Life Questionnaire; MHQoL) | 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. | Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention. |
| One week before the intervention/waitlist control period and one week after the intervention/waitlist control period (i.e., after T0 and after T1). |