Small Children, Big Emotions

Study Overview
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Brief Summary
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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.

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

Conditions
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Emotional Disturbances

Intervention / Treatment
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* Behavioral: Tuning in to Kids
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial with two arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tuning in to Kids<br>Eight weekly two-hour sessions delivered in groups of up to six parents. | Behavioral: Tuning in to Kids<br>* A psychosocial intervention focusing on emotion socialization and emotion coaching.<br>|
| Active Comparator: Treatment as usual<br>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<br>* See description included in arm/Group description.<br>|

What is the study measuring?
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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. |