Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents With ADHD

NCT06711224 | Active Not Recruiting

• 1 other identifier: 654423
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. The adolescents and their parents will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.

Conditions

ADHD

Outcome Measures

Primary Outcomes (9)

• 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.

  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

  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.

  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.

  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.

  Up to 6-month follow-up

• Module completion

  Number of modules completed will be used to assess adherence to the intervention.

  From intervention start and up to 6 weeks.

• Time spent in app

  The time spent in the app will be used to assess adherence

  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

  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.

  Up to 6-month follow-up

Secondary Outcomes (6)

• UCLA loneliness scale

  Up to 6 months follow-up

• Knowledge on ADHD

  Week 6, at the end of the intervention

• Mood

  From intervention start and up to week 6.

• Sleep, eating and exercise habits

  Up to 6 months follow-up

• SNAP IV 18

  Up to 6 months follow-up

Other Outcomes (3)

• The readiness to change questionnaire (RTCQ-6)

  Baseline

• Self-efficacy

  Baseline

• ADHD among relatives

  Baseline

Study Arms (1)

Digital intervention

EXPERIMENTAL

The digital intervention includes a mobile app and weekly phone calls with a therapist.

Behavioral: Digital intervention for adolscents with ADHD

Interventions

Digital intervention for adolscents with ADHD BEHAVIORAL

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.

Digital intervention

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tine Nordgreen, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: December 2, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)