A Brief Emotion Focused Therapy for Preschoolers With Anxiety Disorders

NCT04978844 | Recruiting

• 1 other identifier: Inner World of the Child
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Symptom change as measured by the CBCL

  The CBCL measures symptoms of psychopathology in a quantitive manner. Reduction in the number symptoms means a favorable outcome.

  Every two months for a period of six months

• Maternal Sensitivity as measured with the CIB (coding interactional behavior)

  This measure is a video of mother-child interactions, a higher score is a more favorable outcome. scores range from a minimum of 0 to a maximum of 5.

  Every two months for a period of six months

Study Arms (3)

I-WotCH

ACTIVE COMPARATOR

I-WotCH- Inner World of the Child- is a novel innovative therapy developed in our clinic. The therapy is based on modern concepts of early childhood developments emphasizing themes related to emotional regulation, processes of socialization, observational research on interpersonal and behavior as well as recent developments on affiliative neuroscience. More specifically, the therapist, through play, identifies themes and emotions the child is preoccupied with. The therapist then assists the child in naming these emotions, validating them, exploring their nature and consequences. The therapists discussed ways of managing and self-regulating these emotions. These methods would include behavioral techniques, the ability to enlist help from others and reframing. In addition, the therapy will address dealing with complexed emotions and enhancing symbolic play and joyfulness.

Behavioral: IWOTCH

Dyadic therapy

ACTIVE COMPARATOR

Child parent psychotherapy: CPP consists of joint parent-child sessions that focus on the child's free play and spontaneous parent-child interaction. The CPP therapist acts to "translate" the developmental and emotional meaning of a child's emotions and actions to the parent. The target of treatment includes the both the child's and the caregiver's adaptive conflicts, including a parent's difficulty in providing sensitive and developmentally appropriate care. CPP fosters parent-child activities that foster mutual pleasure, interpersonal trust and understanding. In the purpose of this study only mothers will be included.

Behavioral: Dyadic therapy

Control

NO INTERVENTION

Healthy control.

Interventions

IWOTCH BEHAVIORAL

Arm 1

I-WotCH

Dyadic therapy BEHAVIORAL

Arm 2

Dyadic therapy

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All consecutive admission to the early childhood clinic at the IDC Herzliya

You may not qualify if:

• Parents and children not living in the same household

Sponsors & Collaborators

• Interdisciplinary Center Herzliya: lead

Study Sites (1)

The Preschool clinic at the Interdisciplinary Center Herzlyia

Herzliya, Select A State Or Province, 4634601, Israel

RECRUITING

Study Officials

• Feldman Ruth, Prof

  IDC Herzliya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Apter Levy, Phd

CONTACT

+972546441350; yaelmapter@gmail.com

Maayan Greenberg, MA

CONTACT

0545858464; maayangreen1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessors: Post graduate students in clinical psychology, lab technicians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research psychologist

Model Details: I-WotCH, Dyadic and Controls

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: July 27, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IL (1)