Child Self-regulation: A Pilot Study on the Impact of Tuning in to Kids Parent Intervention
N-TIK Pilot
Child Self-regulation: Impact and Neurocognitive Underpinnings of a Psychosocial Intervention
1 other identifier
interventional
79
1 country
1
Brief Summary
The current pilot project will a) adapt an evidence-based psychosocial intervention program and conduct a randomized controlled trial with a group of Norwegian parents of preschool children, b) evaluate the intervention'simpact on child mental health and c) investigate the cognitive and physiological underpinnings of this effect.This pilot study will recruit 40 Norwegian parents of preschool children prior to the transition to starting school. Baseline measures will include parent emotion coaching and parent functioning, child emotion regulation, social and behavioral functioning, child behavioral and physiological indices of cognitive capacity and attention functioning, and school adjustment. Following completion of baseline assessment, parents will be randomized into Intervention or Wait-list conditions. Intervention parents will attend a 6-session group parenting program where they will learn to emotion coach their children and regulate their own emotions. Post-program, Intervention parents will complete program evaluation to determine program feasibility and acceptability. At 6-month follow-up baseline assessments will be repeated for Intervention and Wait-list participants with primary school teachers reporting on children's adjustment to school. Wait-list parents will then be offered the N-TIK program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 7, 2022
November 1, 2022
11 years
April 14, 2021
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Parent Emotional Style Questionnaire (PESQ)
Parent Emotion Socialization Questionnaire (PESQ) is a scale with items that are scored from 1 to 5, where 5 indicates high levels of specific parenting beliefs (i.e. emotion coaching and emotion dismissive beliefs).
Six months: Change in PESQ from baseline to follow up 6 months after baseline measured by questionnaire reports.
Coping with children negative emotions scale (CCNES)
Coping with children negative emotions scale (CCNES) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of specific parenting behavior (i.e. supportive and nonsupportive parenting behavior).
Six months: Change in CCNES from baseline to 6 months follow-up measured by questionnaire reports.
Eysenck's child behavior questionnaire (ECBI)
Eysenck's child behavior questionnaire (ECBI) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of behavior problems.
Six months: Change in ECBI from baseline to 6 months follow-up measured by questionnaire reports.
Preschool anxiety scale - revised (PAS-R)
Preschool anxiety scale - revised (PAS-R) is a scale with items that are scored from 1 to 5, where higher score indicates higher levels of anxiety.
Six months: Change in PAS-R from baseline to 6 months follow-up measured by questionnaire reports.
Emotional Go/Nogo task (EGNG)
EGNG is a direct assessment of child behavior - an adaptation from the Go/NoGo task - a well-established cognitive paradigm. When modified with emotional stimuli in the form of faces with different positive and negative emotional expressions serving as either target or non-target, the task allows for behavioural assessment of emotion discrimination, emotion regulation and cognitive control, which are related, yet separable processes (Tottenham et al. 2011).
Six months: Change in EGNG from baseline to 6 months follow-up measured by lab assessment.
AX Continuous Performance Task (AX-CPT)
AX-CPT is a direct assessment of child behavior - The AX-CPT task (a version of the classic Continuous Performance Test, Rosvold et al. (1956)) is among the tasks most frequently used to study adaptive cognitive control by cognitive and clinical neuroscientists (Cohen and Servan-Schreiber,1992; Servan-Schreiber et al.,1996). In particular, the task makes it possible to distinguish between proactive or reactive control modes (Braver (2012); Braver et al. 2007).
Six months: Change in AX-CPT from baseline to 6 months follow-up measured by lab assessment.
Test of Emotion Comprehension (TEC)
The TEC is a direct assessment measure used to capture child emotion understanding (Kårstad et al., 2015; Pons \& Harris, 2000). The TEC measures nine components of emotion understanding: 1) emotion recognition, 2) external cause, 3) desire, 4) belief, 5) reminder, 6) regulation, 7) hidden, 8) mixed, and 9) morally based emotions.
Six months: Change in TEC from baseline to 6 months follow-up measured by lab assessment.
Study Arms (2)
Intervention: Tuning in to Kids parenting program
EXPERIMENTALIntervention groups receive the Tuning in to Kids parenting program
Control: Business as usual
NO INTERVENTIONControl groups have "business as usual", and then get offered the intervention program after 6 months follow-up assessment.
Interventions
A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.
Eligibility Criteria
You may qualify if:
- A preschool child aged 5-6 years old
- Parent of a preschool child aged 5-6 years old
You may not qualify if:
- Parents under the age of 18
- Parents not able to read and write in Norwegian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oslo
Oslo, 0358, Norway
Study Officials
- PRINCIPAL INVESTIGATOR
Evalill Bølstad, PhD
University of Oslo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 20, 2021
Study Start
January 1, 2016
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 7, 2022
Record last verified: 2022-11