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 range7 Years – 12 Years

SexALL

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.

What they're measuring

Recruitment pace

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Time between first assessment and treatment initiation

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Treatment hours

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Therapists' views of the intervention

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Patient completion rate

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Trial details

NCT IDNCT05686512

SponsorRegion Stockholm

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Anxiety Disorder trials

Plain-language summary

Who can participate

Age range7 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recruitment pace

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Time between first assessment and treatment initiation

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Treatment hours

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Therapists' views of the intervention

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)

Patient completion rate

Timeframe: Post intervention (defined as 12 weeks after the start of the intervention)