Clinical trial NCT06711224: Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents with ADHD
Official title: Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents with ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

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.

Eligibility criteria: Inclusion criteria:

1. 13-16 years
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:

1. Other primary diagnosis than ADHD (e.g. Autism, intellectual disabilities, severe conduct disorder)
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).

Primary outcomes:
measure: The Credibility and Expectancy Scale (CEQ-1)
timeFrame: First week of intervention
measure: Recruitment rate
timeFrame: From recruitment start and up to 1 year
measure: Satisfaction with intervention
timeFrame: Week 6, at the end of the intervention
measure: The strengths and difficulties questionnaire (SDQ) for self-completion
timeFrame: Up to 6-month follow-up
measure: KIDSCREEN-10
timeFrame: Up to 6-month follow-up
measure: Module completion
timeFrame: From intervention start and up to 6 weeks.
measure: Time spent in app
timeFrame: From intervention start and up to 6 weeks.
measure: Logins to app
timeFrame: From intervention start and up to 6 weeks.
measure: The strengths and difficulties questionnaire (SDQ) for parents
timeFrame: Up to 6-month follow-up
Secondary outcomes:
measure: UCLA loneliness scale
timeFrame: Up to 6 months follow-up
measure: Knowledge on ADHD
timeFrame: Week 6, at the end of the intervention
measure: Mood
timeFrame: From intervention start and up to week 6.
measure: Sleep, eating and exercise habits
timeFrame: Up to 6 months follow-up
measure: SNAP IV 18
timeFrame: Up to 6 months follow-up
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 6-month follow-up
Other outcomes:
measure: The readiness to change questionnaire (RTCQ-6)
timeFrame: Baseline
measure: Self-efficacy
timeFrame: Baseline
measure: ADHD among relatives
timeFrame: Baseline
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tine Nordgreen, PhD
role: PRINCIPAL_INVESTIGATOR
References: