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

Haukeland University Hospital

Status: Enrolling

Conditions: ADHD

Treatments: Behavioral: Digital intervention for adolscents with ADHD

Study type: Interventional

Funder types: Other

Identifiers

NCT06711224

654423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 13 to 16 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Digital intervention

Experimental group

Description:

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

Treatment:

Behavioral: Digital intervention for adolscents with ADHD