NCT07504107

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

March 19, 2026

Last Update Submit

May 11, 2026

Conditions

ADHD

Keywords

ADHDSelf-esteemMaskingComorbidityYoung adultsYouthCBTInterventionRCT

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (10)

  • Change in Masking of ADHD-Related Behavior (MAT-Q)

    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 (Depression subscale of the DASS-42)

    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)

    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)

    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)

    Week 0 (T0; baseline), week 9 (T1; post-intervention or post-waitlist), and week 18 (T2; two-month follow-up or post-intervention.

  • +5 more secondary outcomes

Other Outcomes (1)

  • Momentary self-esteem, distress, emotions, and activity

    One week before the intervention/waitlist control period and one week after the intervention/waitlist control period (i.e., after T0 and after T1).

Study Arms (2)

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

Behavioral: ADHD&me

Waitlist-control (delayed intervention)

OTHER

Participants are assigned to a waitlist and receive the intervention after an 8-week delay.

Behavioral: ADHD&me

Interventions

ADHD&meBEHAVIORAL

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.

Also known as: ADHD&ik
InterventionWaitlist-control (delayed intervention)

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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:
  • Telephone screening. Two items from the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965) are administered ("At times I think I am no good at all" and "All in all, I am inclined to think I am a failure"). A score of 3 (agree) or 4 (strongly agree) on either of these items is considered indicative of low self-esteem.
  • 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.

You may not qualify if:

  • Concurrent psychopathology that requires immediate attention (e.g., severe depression, suicidal thoughts/risk of suicide (as determined by the referring therapist and/or research team). Other comorbidity is allowed.
  • Undergoing any concurrent psychological treatment during the study, including any form of therapy for ADHD (e.g., CBT for planning skills). Psychoeducation completed prior to the study entry is allowed, but not during the study.
  • Low self-esteem that directly stems from a traumatic experience, which would indicate the need for trauma-specific treatment. This will be determined by the referring therapist. If someone in addition suffers from low self-esteem due to the ADHD symptoms, an appropriate timing of each treatment will be dis- cussed by the referring therapist and potential client.
  • IQ \< 80 assessed with two WAIS-IV subscales (Wechsler, 2008): Vocabulary and Block Design.
  • Severe substance use (as determined by the referring therapist and/or research team).
  • Confirmed Autism Spectrum Disorder (ASD) diagnosis. This also applies when the referring therapist indicates that an ASD diagnosis is very likely, even if it has not yet been established. Since ASD diagnostic procedures are time-consuming and fall outside the scope of this research project, formal ASD assessment will not be conducted within this study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychologenpraktijk Kuin

Haarlem, Netherlands

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Bianca Boyer

CONTACT

+31 71 5272727b.e.boyer@fsw.leidenuniv.nl

Jasmin Rahemenia

CONTACT

j.rahemenia@fsw.leidenuniv.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 31, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
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 Criteria
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.

Locations

NL(1)