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The study was terminated due to consequences of the Covid-19 pandemic, which made it impossible to complete the trial in a timely manner and in accordance with the study protocol
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| University of Melbourne | OTHER |
| Extrastiftelsen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tuning in to Kids | Experimental | Eight weekly two-hour sessions delivered in groups of up to six parents. |
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| Treatment as usual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuning in to Kids | Behavioral | A psychosocial intervention focusing on emotion socialization and emotion coaching. |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Aalberg, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BUP Øvre Romerike | Jessheim | Norway | ||||
| BUP Grorud |
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| ID | Term |
|---|---|
| D000342 | Affective Symptoms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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A randomized controlled trial with two arms.
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Outcome assessors are blinded to treatment condition and receive no information about which treatment the participant will receive or have received.
| Treatment as usual | Behavioral | See description included in arm/Group description. |
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| Oslo |
| Norway |
| Nic Waals Institutt | Oslo | Norway |