Small Children, Big Emotions

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

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.

Study Overview

• Status: Terminated
• Conditions: Emotional Disturbances
• Intervention / Treatment: Behavioral: Tuning in to Kids; Behavioral: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Aalberg, PhD; Phone Number: +47 67960000; Email: marianne.aalberg@ahus.no

Study Locations

• Norway
  • Jessheim, Norway
    • BUP Øvre Romerike
  • Oslo, Norway
    • BUP Grorud
  • Oslo, Norway
    • Nic Waals Institutt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tuning in to Kids; Eight weekly two-hour sessions delivered in groups of up to six parents.	Behavioral: Tuning in to Kids; A psychosocial intervention focusing on emotion socialization and emotion coaching.
Active Comparator: Treatment as usual; Treatment as usual, may consist of any psychosocial intervention the therapist sees fit, which is the type of intervention the participants ordinarily receives in the participating clinics. No limit on number of sessions or format of delivery.	Behavioral: Treatment as usual; See description included in arm/Group description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: University of Oslo; University of Melbourne; Extrastiftelsen
• Investigators: Principal Investigator: Marianne Aalberg, Phd, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Affective Symptoms
• Other Study ID Numbers: 18/02391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No