ADHDNCT06711224
Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents With ADHD
A study testing Digital intervention for adolscents with ADHD in people with ADHD, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The main aim of this feasibility trial is to investigate the feasibility and preliminary clinical outcomes of a guided digital intervention for adolescents with ADHD. Adolescents with ADHD will be enrolled in a 6-week digital intervention including weekly therapist contact. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- ADHD
- What is being tested?
- Digital intervention for adolscents with ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 18 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13-16 years
- a diagnosis of ADHD
- parents are willing to participate in answering questionnaires pre, during, post and follow-up
- stable medication during the study period
- participant and parents can read, write and speak Norwegian
- access to mobile phone and internet.
Who cannot join
- Other primary diagnosis than ADHD (e.g. Autism, intellectual disabilities, severe conduct disorder)
- clinically significant comorbid psychiatric disorder requiring treatment (e.g. major depression, severe anxiety, suicidal ideation, eating disorder)
- follows another psychological treatment or intend to start treatment during the intervention period
- do not follow a regular school plan (e.g. frequently with days away from school/class with different educational content than their peers).
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this feasibility trial is to investigate the feasibility and preliminary clinical outcomes of a guided digital intervention for adolescents with ADHD.
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.
Read the detailed description
ADHD is one of the most prevalent diagnoses in childhood. Treatment guidelines recommend inclusion of psychological support, however, there are currently few psychological treatment options for adolescents with ADHD.
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
- Recruitment 1A. How long does it take to recruit 60 adolescents with ADHD? 1B. Is the target group represented in the sample?
- 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)
- Credibility 3A. Will at least 70% of the adolescents recommend the program to a friend with similar challenges?
- Satisfaction 4A. How satisfied are the adolescents with the intervention? 4B. What are the adolescents' experiences with the intervention? (qualitative feedback)
- 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
- ADHD
- Being tested
- Digital intervention for adolscents with ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intervention for adolscents with ADHDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention | Experimental | The digital intervention includes a mobile app and weekly phone calls with a therapist. Receives: Behavioral: Digital intervention for adolscents with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Credibility and Expectancy Scale (CEQ-1)
CEQ-1 will be used after participants have completed the first module of the treatment. CEQ measures perceived treatments credibility. The first item "How confident would you be in recommending this treatment to a friend who experiences similar problems?" will be used. The item is rated on a scale from 0 to 10, where higher score indicates better treatment credibility. The question will be administered to the adolescents.
Measured: First week of intervention
Recruitment rate
The recruitment rate will be assessed by examining number of adolescents recruited per month and total time to recruit 60 adolescents
Measured: From recruitment start and up to 1 year
Satisfaction with intervention
Intervention satisfaction will be measured at post-treatment, using a self-developed questionnaire including 15 items. This questionnaire will be administered to the adolescents.
Measured: Week 6, at the end of the intervention
The strengths and difficulties questionnaire (SDQ) for self-completion
The strengths and difficulties questionnaire (SDQ) is a questionnaire that consisting of 25 items describing positive and negative attributes of children. Each item is rated on a 3-point scale with response options; not true, somewhat true and certainly true. The questionnaire includes five sub-scales with five items each: 1) emotional symptoms, 2) conduct problems, 3) hyperactivity-inattention problems, 4) peer relationships, and 5) pro-social behavior. The SDQ will be administered to the adolscents. For each of the 5 scales the score can range from 0 to 10 if all items were completed. In addition, a total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, where a higher score indicates a higher severity. Lastly, items on overall distress and impairment can be summed to generate an impact score that ranges from 0 to 10, where a higher score indicates higher severity.
Measured: Up to 6-month follow-up
KIDSCREEN-10
KIDSCREEN-10 is a questionnaire to assess health-related quality of life. The items are rated on 5-point Likert scale that indicates the frequency or intensity of a behavior or emotion. For most items, a higher score reflects higher health-related quality of life. This questionnaire will be administered to the adolescents.
Measured: Up to 6-month follow-up
Module completion
Number of modules completed will be used to assess adherence to the intervention.
Measured: From intervention start and up to 6 weeks.
Time spent in app
The time spent in the app will be used to assess adherence
Measured: From intervention start and up to 6 weeks.
Logins to app
Number of logins to the app will be used to assess adherence to the intervention
Measured: From intervention start and up to 6 weeks.
The strengths and difficulties questionnaire (SDQ) for parents
The strengths and difficulties questionnaire (SDQ) is a questionnaire that consisting of 25 items describing positive and negative attributes of children. Each item is rated on a 3-point scale with response options; not true, somewhat true and certainly true. The questionnaire includes five sub-scales with five items each: 1) emotional symptoms, 2) conduct problems, 3) hyperactivity-inattention problems, 4) peer relationships, and 5) pro-social behavior. For each of the 5 scales the score can range from 0 to 10 if all items were completed. In addition, a total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, where a higher score indicates a higher severity. Lastly, items on overall distress and impairment can be summed to generate an impact score that ranges from 0 to 10, where a higher score indicates higher severity.
Measured: Up to 6-month follow-up
Secondary outcomes (6)
UCLA loneliness scale
UCLA loneliness scale measures subjective feelings of loneliness and social isolation. The questionnaire is a 20 item scale where participants rate either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). The total score ranges from 20 to 80. Higher scores indicate higher loneliness. The scale will be administered to the adolescents.
Measured: Up to 6 months follow-up
Knowledge on ADHD
Knowledge on ADHD: The adolescents will be asked: "do you experience increased knowledge about ADHD after participating in this program?" as a part of the post-treatment assessment. The response options will include: "not at all", "to a small extent" "to some extent", to a good extent" and "to a large extent".
Measured: Week 6, at the end of the intervention
Mood
As a part of the intervention, the adolescents will be asked to rate their mood daily in the mobile app using cartoons with response options ranging from "awful", "not so good", "okay", "pretty good" and "amazing".
Measured: From intervention start and up to week 6.
Sleep, eating and exercise habits
As a part of the 3 module, the adolescents will be asked to either rate of their sleep, eating or exercise habits on daily basis. They will be asked how satisfied they with their eating / sleeping / exercise habits on a scale from 1 (Very dissatisfied) to 5 (Very satisfied) and how much their eating / sleeping / exercise habits is affecting their daily functioning on a scale from 1 (Not at all) to 5 (Very much). The adolescents choose themselves what area (eating, sleeping or exercise habits) they want to focus on. In addition, the adolescents will be asked these questions at pre, post and follow-up.
Measured: Up to 6 months follow-up
SNAP IV 18
The Norwegian version of the SNAP-IV 18 consists of the 18 symptoms for ADHD as described by the DSM-IV. The scale includes on inattention subscale and one hyperactivity subscale. Responses are rated on a 4-point scale with response options: not at all/just a little bit/quite a bit/very much. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. The questionnaire will be administered to parents at pre, post, and 3 and 6 months after the treatment.
Measured: Up to 6 months follow-up
Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale (DERS) measures emotion regulation problems. The study will apply the short version containing 16 items with the following sub-scales: nonacceptance of emotional responses; difficulty engaging in goal-directed behaviour; impulse control difficulties; lack of emotional awareness; limited access to emotion regulation strategies; lack of emotional clarity. The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation. This questionnaire will be administered to the adolescents.
Measured: Up to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start18 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tine Nordgreen, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711224
- Sponsor's protocol ID
- 654423
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT06711224
- Acronym / sponsor ID
- 654423
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this feasibility trial is to investigate the feasibility and preliminary clinical outcomes of a guided digital intervention for adolescents with ADHD.
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
ADHD is one of the most prevalent diagnoses in childhood. Treatment guidelines recommend inclusion of psychological support, however, there are currently few psychological treatment options for adolescents with ADHD.
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
- Recruitment 1A. How long does it take to recruit 60 adolescents with ADHD? 1B. Is the target group represented in the sample?
- 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)
- Credibility 3A. Will at least 70% of the adolescents recommend the program to a friend with similar challenges?
- Satisfaction 4A. How satisfied are the adolescents with the intervention? 4B. What are the adolescents' experiences with the intervention? (qualitative feedback)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital intervention | Experimental | Behavioral: Digital intervention for adolscents with ADHDThe digital intervention includes a mobile app and weekly phone calls with a therapist. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 13-16 years
- a diagnosis of ADHD
- parents are willing to participate in answering questionnaires pre, during, post and follow-up
- stable medication during the study period
- participant and parents can read, write and speak Norwegian
Key exclusion criteria (4 listed)
- Other primary diagnosis than ADHD (e.g. Autism, intellectual disabilities, severe conduct disorder)
- clinically significant comorbid psychiatric disorder requiring treatment (e.g. major depression, severe anxiety, suicidal ideation, eating disorder)
- follows another psychological treatment or intend to start treatment during the intervention period
- do not follow a regular school plan (e.g. frequently with days away from school/class with different educational content than their peers).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital intervention for adolscents with ADHDThe 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. | Behavioural | Digital intervention |
Primary outcome
The Credibility and Expectancy Scale (CEQ-1)
Time frame: First week of intervention
CEQ-1 will be used after participants have completed the first module of the treatment. CEQ measures perceived treatments credibility. The first item "How confident would you be in recommending this treatment to a friend who experiences similar problems?" will be used. The item is rated on a scale from 0 to 10, where higher score indicates better treatment credibility. The question will be administered to the adolescents.
Recruitment rate
Time frame: From recruitment start and up to 1 year
The recruitment rate will be assessed by examining number of adolescents recruited per month and total time to recruit 60 adolescents
Satisfaction with intervention
Time frame: Week 6, at the end of the intervention
Intervention satisfaction will be measured at post-treatment, using a self-developed questionnaire including 15 items. This questionnaire will be administered to the adolescents.
The strengths and difficulties questionnaire (SDQ) for self-completion
Time frame: Up to 6-month follow-up
The strengths and difficulties questionnaire (SDQ) is a questionnaire that consisting of 25 items describing positive and negative attributes of children. Each item is rated on a 3-point scale with response options; not true, somewhat true and certainly true. The questionnaire includes five sub-scales with five items each: 1) emotional symptoms, 2) conduct problems, 3) hyperactivity-inattention problems, 4) peer relationships, and 5) pro-social behavior. The SDQ will be administered to the adolscents. For each of the 5 scales the score can range from 0 to 10 if all items were completed. In addition, a total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, where a higher score indicates a higher severity. Lastly, items on overall distress and impairment can be summed to generate an impact score that ranges from 0 to 10, where a higher score indicates higher severity.
KIDSCREEN-10
Time frame: Up to 6-month follow-up
KIDSCREEN-10 is a questionnaire to assess health-related quality of life. The items are rated on 5-point Likert scale that indicates the frequency or intensity of a behavior or emotion. For most items, a higher score reflects higher health-related quality of life. This questionnaire will be administered to the adolescents.
Module completion
Time frame: From intervention start and up to 6 weeks.
Number of modules completed will be used to assess adherence to the intervention.
Time spent in app
Time frame: From intervention start and up to 6 weeks.
The time spent in the app will be used to assess adherence
Logins to app
Time frame: From intervention start and up to 6 weeks.
Number of logins to the app will be used to assess adherence to the intervention
The strengths and difficulties questionnaire (SDQ) for parents
Time frame: Up to 6-month follow-up
The strengths and difficulties questionnaire (SDQ) is a questionnaire that consisting of 25 items describing positive and negative attributes of children. Each item is rated on a 3-point scale with response options; not true, somewhat true and certainly true. The questionnaire includes five sub-scales with five items each: 1) emotional symptoms, 2) conduct problems, 3) hyperactivity-inattention problems, 4) peer relationships, and 5) pro-social behavior. For each of the 5 scales the score can range from 0 to 10 if all items were completed. In addition, a total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, where a higher score indicates a higher severity. Lastly, items on overall distress and impairment can be summed to generate an impact score that ranges from 0 to 10, where a higher score indicates higher severity.
6 secondary outcomes
UCLA loneliness scale
Time frame: Up to 6 months follow-up
Knowledge on ADHD
Time frame: Week 6, at the end of the intervention
Mood
Time frame: From intervention start and up to week 6.
Sleep, eating and exercise habits
Time frame: Up to 6 months follow-up
SNAP IV 18
Time frame: Up to 6 months follow-up
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Up to 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine Nordgreen, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention for adolscents with ADHD in people with ADHD, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Credibility and Expectancy Scale (CEQ-1) (time frame: First week of intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.