Parent and Child Emotional Intelligence and Child Self-regulationN-TIK PilotNCT04851704
Child Self-regulation: A Pilot Study on the Impact of Tuning in to Kids Parent Intervention
A study testing Tuning in to Kids in people with Parent and Child Emotional Intelligence and Child Self-regulation, run by University of Oslo at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent and Child Emotional Intelligence and Child Self-regulation
- What is being tested?
- Tuning in to Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A preschool child aged 5-6 years old
- Parent of a preschool child aged 5-6 years old
Who cannot join
- Parents under the age of 18
- Parents not able to read and write in Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Child Self-regulation: Impact and Neurocognitive Underpinnings of a Psychosocial Intervention
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.
Read the detailed description
Promoting the emotional functioning of preschool children prior to the transition to school has important implications for their adjustment and mental health. Parents can assist children to understand and regulate their emotions thereby better equipping the child as they face this often highly stressful and anxiety provoking period. In addition, we need more knowledge on how processes on both behavioral and physiological levels can contribute to explain the mechanisms underlying changes in child self-regulation influenced by parents and the home environment.
Thus, a 2 x 2 intervention design pilot study of the Norwegian version of Tuning in to Kids (N-TIK) comparing intervention and wait-list participants will examine:
- Does N-TIK lead to better parent-reported parent emotion coaching? ii) Does N-TIK lead to better parent-reported child emotional competencies, mental health and adjustment? iii) Does N-TIK lead to improved child attentional and executive functions as measured by behavioral performance and changes in neural and pupillometric responses in experimental tasks? The intervention aims to improve the responsiveness of parents to emotions, both in themselves and their children. Theoretically, this is anticipated to lead to children developing greater awareness and knowledge of their own emotional experience, to reduced levels of emotionality, and to greater internal self-awareness of their emotions (cognitive awareness about emotional experience). These comprise some of the core emotional competencies relevant for enhancing the transition to school. In turn these competencies are anticipated to be related to greater emotional, cognitive and physiological regulation as assessed by experimental paradigms and physiological measures. For children at risk (due to limited emotional, cognitive, physiological and behavioural regulation), an intervention that assists their parents to learn specific skills that enhance their emotion-related parenting, these risks are likely to be mitigated.
This study will be highly innovative on several counts. It will: gather preliminary evidence using a 2 x 2 intervention design for the effectiveness of an emotion-focused parenting program using a Norwegian sample; use cutting-edge behavioral and physiological measures to see whether participation in N-TIK leads to improved child attentional and executive functions - critical skills that assist with learning and self-regulation; integrate important disciplines within psychology by combining an intervention including preventive actions with emotional, neurocognitive and physiological approaches within adevelopmental psychological framework.
Statistical Analyses Time 1 data will be examined to determine relationships between key constructs. ANCOVA will be used to examine changes over time and to compare Intervention and Wait-list participants on all outcomes.
Ethical aspects The research will be carried out according to the Helsinki declaration, and we will go to great lengths to ensure proper ethical treatment. The potential risks involved in this study relate to where concerns might arise with parents, or where parents have specific difficulties with children: 1. Families who show significant levels of distress and difficulty during the program will have access to appropriate support and intervention services. If during the research period the investigators believe that either the children or the parents are experiencing serious psychological difficulties, if issues of abuse are suspected, or if parents themselves request support or intervention, the investigators will discuss with the family what appropriate professional intervention services are available, and assist in a referral. 2. Issues of confidentiality: Because many of the sample will be recruited from preschool classes, teachers and other parents will be aware of individuals who are part of the research and the groups. Teachers will not be given information gained from the parents. At the beginning of each of the six sessions, parents will be reminded that all material or issues discussed in groups remains confidential and should not be discussed with anyone outside of the group. Issues of confidentiality will only be broken should the research investigators feel that either a child or parent is at undue risk of being harmed/or harming others. Should this occur, parents and children will be fully informed about the processes involved in initiating assistance. 3. The specific methods used in this research are unlikely to be a potential risk to participants. The questionnaires used in the assessment have been widely used in previous research, and have been found not to cause undue concern. The home observation task requires the parent and child to read a story together and talk about the emotions in the story while being videotaped. This is not thought to be likely to cause undue concern. However, if parents find any material in the group, questionnaires, or home observation causes them any difficulty, they will be encouraged to talk with one of the two group leaders and/or to contact the research investigators, and they will be offered referrals to appropriate services should these be required. There are no risks associated with the laboratory assessment.4. The research involves a wait-list control group where half the participants are assigned to wait for a six-month period before receiving the intervention. Should any problems occur during this six-month period, the study investigators would refer the family for appropriate assistance. 5. Should any of the material or exercises performed in the group cause undue concern, immediate debriefing with the group leaders will be provided.
The applicant, Dr Karevold, is an authorized clinical psychologist and thus legally obliged to follow the Health Personnel Act. All research activities will be performed accordingly to ensure participants' personal integrity and health. General guidelines for research will be followed.
- Being tested
- Tuning in to Kids
- Keywords
- Tuning in to Kids, Parent Interventions, Child self-regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuning in to KidsBehavioural
A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Tuning in to Kids parenting program | Experimental | Intervention groups receive the Tuning in to Kids parenting program Receives: Behavioral: Tuning in to Kids |
| Control: Business as usual | No intervention | Control groups have "business as usual", and then get offered the intervention program after 6 months follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Six months: Change in TEC from baseline to 6 months follow-up measured by lab assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent and Child Emotional Intelligence and Child Self-regulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention-control trial, where both intervention and control group participants are assessed at baseline, and then the intervention groups get the intervention, and all group participants are assessed at follow up.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evalill Bølstad, PhD, University of Oslo
- Investigators
- Evalill Bølstad, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851704
- Sponsor's protocol ID
- 2015/2383 REK
- Acronym
- N-TIK Pilot
- Status last verified
- Nov 2022
- First submitted
- 14 Apr 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child Self-regulation: Impact and Neurocognitive Underpinnings of a Psychosocial Intervention
- ClinicalTrials.gov ID
- NCT04851704
- Acronym / sponsor ID
- N-TIK Pilot / 2015/2383 REK
- Keywords
- Tuning in to Kids, Parent Interventions, Child self-regulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Promoting the emotional functioning of preschool children prior to the transition to school has important implications for their adjustment and mental health. Parents can assist children to understand and regulate their emotions thereby better equipping the child as they face this often highly stressful and anxiety provoking period. In addition, we need more knowledge on how processes on both behavioral and physiological levels can contribute to explain the mechanisms underlying changes in child self-regulation influenced by parents and the home environment.
Thus, a 2 x 2 intervention design pilot study of the Norwegian version of Tuning in to Kids (N-TIK) comparing intervention and wait-list participants will examine:
- Does N-TIK lead to better parent-reported parent emotion coaching? ii) Does N-TIK lead to better parent-reported child emotional competencies, mental health and adjustment? iii) Does N-TIK lead to improved child attentional and executive functions as measured by behavioral performance and changes in neural and pupillometric responses in experimental tasks? The intervention aims to improve the responsiveness of parents to emotions, both in themselves and their children. Theoretically, this is anticipated to lead to children developing greater awareness and knowledge of their own emotional experience, to reduced levels of emotionality, and to greater internal self-awareness of their emotions (cognitive awareness about emotional experience). These comprise some of the core emotional competencies relevant for enhancing the transition to school. In turn these competencies are anticipated to be related to greater emotional, cognitive and physiological regulation as assessed by experimental paradigms and physiological measures. For children at risk (due to limited emotional, cognitive, physiological and behavioural regulation), an intervention that assists their parents to learn specific skills that enhance their emotion-related parenting, these risks are likely to be mitigated.
This study will be highly innovative on several counts. It will: gather preliminary evidence using a 2 x 2 intervention design for the effectiveness of an emotion-focused parenting program using a Norwegian sample; use cutting-edge behavioral and physiological measures to see whether participation in N-TIK leads to improved child attentional and executive functions - critical skills that assist with learning and self-regulation; integrate important disciplines within psychology by combining an intervention including preventive actions with emotional, neurocognitive and physiological approaches within adevelopmental psychological framework.
Statistical Analyses Time 1 data will be examined to determine relationships between key constructs. ANCOVA will be used to examine changes over time and to compare Intervention and Wait-list participants on all outcomes.
Ethical aspects The research will be carried out according to the Helsinki declaration, and we will go to great lengths to ensure proper ethical treatment. The potential risks involved in this study relate to where concerns might arise with parents, or where parents have specific difficulties with children: 1. Families who show significant levels of distress and difficulty during the program will have access to appropriate support and intervention services. If during the research period the investigators believe that either the children or the parents are experiencing serious psychological difficulties, if issues of abuse are suspected, or if parents themselves request support or intervention, the investigators will discuss with the family what appropriate professional intervention services are available, and assist in a referral. 2. Issues of confidentiality: Because many of the sample will be recruited from preschool classes, teachers and other parents will be aware of individuals who are part of the research and the groups. Teachers will not be given information gained from the parents. At the beginning of each of the six sessions, parents will be reminded that all material or issues discussed in groups remains confidential and should not be discussed with anyone outside of the group. Issues of confidentiality will only be broken should the research investigators feel that either a child or parent is at undue risk of being harmed/or harming others. Should this occur, parents and children will be fully informed about the processes involved in initiating assistance. 3. The specific methods used in this research are unlikely to be a potential risk to participants. The questionnaires used in the assessment have been widely used in previous research, and have been found not to cause undue concern. The home observation task requires the parent and child to read a story together and talk about the emotions in the story while being videotaped. This is not thought to be likely to cause undue concern. However, if parents find any material in the group, questionnaires, or home observation causes them any difficulty, they will be encouraged to talk with one of the two group leaders and/or to contact the research investigators, and they will be offered referrals to appropriate services should these be required. There are no risks associated with the laboratory assessment.4. The research involves a wait-list control group where half the participants are assigned to wait for a six-month period before receiving the intervention. Should any problems occur during this six-month period, the study investigators would refer the family for appropriate assistance. 5. Should any of the material or exercises performed in the group cause undue concern, immediate debriefing with the group leaders will be provided.
The applicant, Dr Karevold, is an authorized clinical psychologist and thus legally obliged to follow the Health Personnel Act. All research activities will be performed accordingly to ensure participants' personal integrity and health. General guidelines for research will be followed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention-control trial, where both intervention and control group participants are assessed at baseline, and then the intervention groups get the intervention, and all group participants are assessed at follow up.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Tuning in to Kids parenting program | Experimental | Behavioral: Tuning in to KidsIntervention groups receive the Tuning in to Kids parenting program |
| Control: Business as usual | No intervention | –Control groups have "business as usual", and then get offered the intervention program after 6 months follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A preschool child aged 5-6 years old
- Parent of a preschool child aged 5-6 years old
Key exclusion criteria (2 listed)
- Parents under the age of 18
- Parents not able to read and write in Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuning in to KidsA parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus. | Behavioural | Intervention: Tuning in to Kids parenting program |
Primary outcome
Parent Emotional Style Questionnaire (PESQ)
Time frame: Six months: Change in PESQ from baseline to follow up 6 months after baseline measured by questionnaire reports.
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).
Coping with children negative emotions scale (CCNES)
Time frame: Six months: Change in CCNES from baseline to 6 months follow-up measured by questionnaire reports.
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).
Eysenck's child behavior questionnaire (ECBI)
Time frame: Six months: Change in ECBI from baseline to 6 months follow-up measured by questionnaire reports.
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.
Preschool anxiety scale - revised (PAS-R)
Time frame: Six months: Change in PAS-R from baseline to 6 months follow-up measured by questionnaire reports.
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.
Emotional Go/Nogo task (EGNG)
Time frame: Six months: Change in EGNG from baseline to 6 months follow-up measured by lab assessment.
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).
AX Continuous Performance Task (AX-CPT)
Time frame: Six months: Change in AX-CPT from baseline to 6 months follow-up measured by lab assessment.
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).
Test of Emotion Comprehension (TEC)
Time frame: Six months: Change in TEC from baseline to 6 months follow-up measured by lab assessment.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evalill Bølstad, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuning in to Kids in people with Parent and Child Emotional Intelligence and Child Self-regulation, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Emotional Style Questionnaire (PESQ) (time frame: Six months: Change in PESQ from baseline to follow up 6 months after baseline measured by questionnaire reports.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.