Small Children, Big Emotions

Emotional Disturbances Clinical Trial

Official title:

Tuning in to Kids: an Effectiveness Evaluation of Emotion Coaching to Parents and Daycare Teachers of At-risk Young Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04108949
• Other study ID #: 18/02391
• Status: Terminated
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: October 13, 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Referred children aged 2-5 years

• The child is enrolled in daycare

• The child is displaying problems with emotional dysregulation

Exclusion Criteria:

• Parent not sufficiently proficient in Norwegian Language to Complete assessment

• Child Protective Services have ongoing assessment where the outcome may be that the child will be placed in care outside of the home of the biological parent(s) or other current caregiver

• The child has already been diagnosed with an autism spectrum disorder

Related Conditions & MeSH terms

• Affective Symptoms
• Emotional Disturbances

Intervention

Behavioral:
• Tuning in to Kids
A psychosocial intervention focusing on emotion socialization and emotion coaching.
• Treatment as usual
See description included in arm/Group description.

Locations

Country	Name	City	State
Norway	BUP Øvre Romerike	Jessheim
Norway	BUP Grorud	Oslo
Norway	Nic Waals Institutt	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Akershus	Extrastiftelsen, University of Melbourne, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coping with Toddlers' Negative Emotion Scale	A measure of parental behaviors in respond to toddlers' emotions. CTNES consists of 12 hypothetical situation where parents rate their likelihood of responding in six different ways on a scale from 1 (very unlikely) to 7 (very likely).	CTNES will be completed at baseline, post treatment (week 12) and follow-up month 9 after inclusion) to evaluate change from baseline to post-treatment and follow-up.