Small Children, Big Emotions

Not Applicable

Terminated

• Conditions: Emotional Disturbances
• Interventions: Behavioral: Tuning in to Kids; Behavioral: Treatment as usual

• Registration Number: NCT04108949
• Lead Sponsor: University Hospital, Akershus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Primary Completion: 2021-10-13
• Study Completion: 2021-10-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tuning in to Kids	Tuning in to Kids	Eight weekly two-hour sessions delivered in groups of up to six parents.
Treatment as usual	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.

Primary Outcome Measures

Name	Time	Method
Coping with Toddlers' Negative Emotion Scale	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.	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).

Trial Locations

Locations (3)

BUP Øvre Romerike; 🇳🇴 Jessheim, Norway

Nic Waals Institutt; 🇳🇴 Oslo, Norway

BUP Grorud; 🇳🇴 Oslo, Norway