1) the OST is superior to the 3-weeks waiting period 2) the OST+app is superior to the OST-only at post-treatment and at follow-up
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Health condition
specific phobia
Research involving
Sponsors and support
Intervention
- Psychosocial intervention
Outcome measures
Primary outcome
- ADIS diagnosis specific phobia
- Severity rating of ADIS for specific phobia
- questionnaire that measures self-reported fear, avoidance and severity of specific phobia
- Adapted Sheehan Disability scale, self-reported burden of specific phobia
- Behavioral Approach Task
Secondary outcome
- Spence Anxiety Scale (SCAS)
- Fear Survey Short form (FSSC-R-SF)
- Short mood and feelings questionnaire (SMFQ)
- Clinical Global Impression Scale (CGI)
Background summary
Goals: To improve early recognition and intervention for specific phobias and to personalize their treatment among children. More specifically, we will test: 1) the efficacy of a low-cost evidence-based early intervention (One-Session Treatment, OST) for specific phobias in a population of Dutch and German children, 2) whether a newly developed, theory-driven personalised app, supporting the intervention, adds to the short- and long-term effectiveness of the intervention in term of anxiety symptoms reduction and functioning, 3) what active underlying mechanisms of OST can by identified, including biased cognitive processes.
Methods and Study Type: This study employs a multicenter pragmatic randomised controlled trial with 2 active treatments, and a 3-week waiting baseline control period. In total, 173 children will be included who have a clinical specific phobia with a request for help between the ages of 7 and 14 years. The two active treatments will either be 1) a combination of the face-to-face OST supported by an app that helps children to complete exposure exercises for 4 weeks following OST, or 2) face-to-face OST only without the personalized app. The interactive app will be therapist-supported, personalized to, for example, age, gender, subtype of fear of the child and contain movie fragments of the child’s own OST session. Additionally, the study includes cognitive and behavioral measures and follows a multi-informant approach including reports from children, parents, and therapists.
Innovation and Significance: This project will be the first study worldwide to test an early intervention One-Session Treatment for children supplemented by a therapist-supported personalised app. It is the next step to develop short, low-cost, efficient and effective early interventions for high-risk children. By combining clinical studies with fundamental research on childhood specific phobias, we can further develop the efficacy of treatments. Earlier and more successful treatment of childhood specific phobias will reduce the suffering of children and their families, and may also prevent the development of mental health problems and improve functioning later in life.
Study objective
2) the OST+app is superior to the OST-only at post-treatment and at follow-up
Study design
Intervention
Study burden and risks
Age
Inclusion criteria
1) A primary diagnoses of specific phobia according to the DSM-5 2) one or both parents are willing to be actively involved in the study, and active consent is obtained of both legal guardians 3) age 7-14 years 4) good command of Dutch or German
Exclusion criteria
1) currently co-morbid problem that requires immediate attention/treatment 2) child hazard 3) problems with understanding the procedure (e.g., be intellectually unable) 4) changes in anxiety medication during treatment 5) other treatment targeting anxiety complaints during the treatment
Design
Recruitment
IPD sharing statement
Plan description
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9216 |
CCMO | NL72697.018.20 |
OMON | NL-OMON55077 |