A Brief Emotion Focused Therapy for Preschoolers With Anxiety Disorders (NCT04978844) | Clinical Trial Compass
UnknownNot Applicable
A Brief Emotion Focused Therapy for Preschoolers With Anxiety Disorders
Israel40 participantsStarted 2021-04-01
Plain-language summary
The study will comprise of three groups of children (n=40): 1. A group receiving a novel short-term dynamic play therapy. 2. Dyadic therapy 3. Control group who will not receive therapy. All children will be assessed for psychopathology (anxiety, depression and behavioral problems) using standardized instruments such as semi-structured interview and self-reported questionnaires; EEG recordings will be performed from child and parents in order to asses brain synchrony; Cortisol (CT), Dehydroepiandrosterone (DHEA), Oxytocin (OT) and Secretory Immunoglobulin A (SIgA) will be assessed by using saliva sampling; and father-mother-child interactions will be videotaped and analyzed. Narrative descriptions will be obtained from parents, and the interviews recorded for voice analysis. Assessment will be made at baseline and then bi-monthly for six months.
Who can participate
Age range
3 Years – 6 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:
All consecutive admission to the early childhood clinic at the IDC Herzliya
Exclusion Criteria:
Parents and children not living in the same household
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.
1This trial focuses on preschool-aged children with anxiety disorders — would my child's age and specific type of anxiety actually make them a good candidate to discuss with you?
2The study is measuring both the child's anxiety symptoms using the CBCL and something called 'maternal sensitivity' using a behavior coding tool — what does it mean that the parent-child relationship is being evaluated, and how might that affect our family's experience in this kind of therapy?
3Since this trial is listed as 'emotion focused therapy,' how does that approach compare to more established treatments for preschool anxiety, like parent-child interaction therapy or CBT, and is there a reason you'd recommend one over the other for my child right now?
4The recruitment status for this trial is listed as unknown, so before we go further, can you help us find out whether this study is still actively enrolling and how we could get more current information?
5Given that this is a non-drug therapy trial with no assigned phase, what do we know so far about whether brief emotion focused therapy is safe and effective for very young children, and are there any risks to participating that I should understand?
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
Symptom change as measured by the CBCL
Timeframe: Every two months for a period of six months
2
Maternal Sensitivity as measured with the CIB (coding interactional behavior)
Timeframe: Every two months for a period of six months