Initial Evaluation of a Stepped Care Model for Treating Mild to Moderate Childhood Anxiety in Pri… (NCT05686512) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Initial Evaluation of a Stepped Care Model for Treating Mild to Moderate Childhood Anxiety in Primary Care
Sweden30 participantsStarted 2023-02-13
Plain-language summary
Objectives: In the past ten years in Sweden, a new form of primary care units called first line mental health (FLMH) has been implemented to improve mental health services for children and adolescents. Using a structured and collaborative approach including experts, clinicians, and patients, the investigators have developed a transdiagnostic psychological intervention for anxiety based on cognitive behavioural therapy (CBT) that aims to fit the FLMH care context. The current study aims to test the CBT intervention "Step-by-Step" in a randomized pilot study (N=36) to explore the feasibility of the study design.
Rationale for study: Childhood anxiety is common and associated with suffering and impairment in several life areas. CBT is an evidence-based treatment for anxiety disorders in children, but there is a need of increasing access to treatment. Offering CBT for childhood anxiety in primary care is a way to offer early and accessible treatment. However, there is a lack of CBT interventions developed for and evaluated in primary care.
Prior to a properly powered randomized controlled study, evaluating efficacy of the Step-by-Step, the investigators need to conduct a pilot study to, primarily, establish the feasibility of the study design and trial procedures and secondarily, provide preliminary data on acceptability and clinical efficacy.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The child is 7-12 years old. Confirmed by the caregiver and subsequently by the medical records.
* The child suffers from mild to moderate anxiety. The term "mild to moderate anxiety" has not been explicitly defined but is a term aimed to specify a demarcation between the FLMH and the psychiatric specialist services. Adequate level of care for the patient is decided based on an overall clinical assessment. The Children Global Assessment Scale (CGAS) is often used to guide the decision on level of care, where a CGAS value above 60 clearly indicates primary care services, a value below 50 clearly indicates specialist services. For values between 50 and 60 the overall clinical evaluation of symptom severity and impaired function guide the decision on level of care. Confirmed by the assessor at the FLMH-unit
Exclusion Criteria:
* Other psychiatric or developmental disorders than anxiety, or social issues that primarily require other interventions (i.e., where an intervention targeting mild to moderate anxiety is not adequate). Confirmed by assessor at the FLMH-unit.
* The child has another ongoing psychological intervention. An ongoing psychological treatment for any other psychiatric disorder. Confirmed by the caregiver.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment pace
Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)
2
Time between first assessment and treatment initiation
Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)
3
Treatment hours
Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)
4
Therapists' views of the intervention
Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)
5
Patient completion rate
Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)