Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents With ADHD
NCT ID: NCT06711224
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-18
2027-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Adolescents with ADHD will be enrolled in a 6-week digital intervention including weekly therapist contact. The adolescents and their parents will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The current study investigates the feasibility and preliminary effects of therapist-guided digital treatment for adolescents with ADHD using qualitative and quantitative methods. The project uses the person-based approach (PBA) as methodological framework, which is an evidence-based method for developing user-centered and effective behavior change interventions.
The study seeks the examine the intervention within five feasibility domains that includes the following research questions
1. Recruitment 1A. How long does it take to recruit 60 adolescents with ADHD? 1B. Is the target group represented in the sample?
2. Adherence 2A. Does a minimum of 50% complete the intervention? 2B. What characterizes the adolescents who complete the intervention? (predictor) 2C. What characterizes the adolescents who dropout of the intervention? (predictor)
3. Credibility 3A. Will at least 70% of the adolescents recommend the program to a friend with similar challenges?
4. Satisfaction 4A. How satisfied are the adolescents with the intervention? 4B. What are the adolescents' experiences with the intervention? (qualitative feedback)
5. Preliminary clinical outcomes 5A. Will a moderate effect (d = 0.5) on outcomes related to everyday functioning, quality of life and ADHD symptoms be found? 5B. Will more than 40% of the participants experience reliable clinical change (RCI) on the primary clinical outcomes? 5C. Will less than 10% of the participants experience negative clinical effects, defined as a negative RCI?
Youth between the ages of 13 to 16 years and their parents will be invited to participate in this study. The participants will be recruited via child and youth psychiatric outpatient clinics. Eligible participants get access to an online information consent form which is signed digitally using the Norwegian electronic identification system BankID.
Data will be collected using self-report questionnaires administrated online at pre-, during, post- and 3- and 6-months follow-up. The investigators will also conduct semi-structured phone interviews to explore the patients' in-depth experience of the digital treatment. The interviews of approximately 16 adolescents will be conducted 2 to 4 weeks after finishing the treatment. The investigators will strive to have two groups, one with participants that completed the treatment, and one with dropouts.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Digital intervention
The digital intervention includes a mobile app and weekly phone calls with a therapist.
Digital intervention for adolscents with ADHD
The aim of the digital intervention is to promote coping of ADHD. The intervention has a duration of 6 weeks and will be delivered as a mobile app including weekly phone calls from a therapist. The intervention includes text, interactive exercises, animations, and coping skills. The themes of the intervention includes psychoeducation on ADHD, healthy habits (sleep, exercise, food), social skills, and emotion regulation. The adolescents have the possibility to choose some of the themes they want to work on during the intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Digital intervention for adolscents with ADHD
The aim of the digital intervention is to promote coping of ADHD. The intervention has a duration of 6 weeks and will be delivered as a mobile app including weekly phone calls from a therapist. The intervention includes text, interactive exercises, animations, and coping skills. The themes of the intervention includes psychoeducation on ADHD, healthy habits (sleep, exercise, food), social skills, and emotion regulation. The adolescents have the possibility to choose some of the themes they want to work on during the intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. a diagnosis of ADHD
3. parents are willing to participate in answering questionnaires pre, during, post and follow-up
4. stable medication during the study period
5. participant and parents can read, write and speak Norwegian
6. access to mobile phone and internet.
Exclusion Criteria
2. clinically significant comorbid psychiatric disorder requiring treatment (e.g. major depression, severe anxiety, suicidal ideation, eating disorder)
3. follows another psychological treatment or intend to start treatment during the intervention period
4. do not follow a regular school plan (e.g. frequently with days away from school/class with different educational content than their peers).
13 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haukeland University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tine Nordgreen, PhD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Haukeland University Hospital
Bergen, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Emilie Nordby, Msc
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
654423
Identifier Type: -
Identifier Source: org_study_id