- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350083
Tuning in to Kids® for Parents of Preschool-aged Children in Portugal (TIK-PT)
Promoting Parental and Child Mental Health Through Emotion-focused Parenting Programs: Adaptation, Implementation, and Evaluation of Tuning in to Kids® in Portugal
Early parent-child interactions, namely how parents respond to their children's emotions (i.e., emotion socialization parenting practices [ESPP]), may play a critical role in how children develop emotion regulation abilities. When parents rely on unsupportive ESPP, this can result in regulatory problems, which are a transdiagnostic symptom of MH problems, being a major cause of its etiology. Emotion-focused parenting programs, such as Tuning in to Kids® (TIK), promote parents' emotion coaching skills, enabling children to understand and regulate their emotions in more effective ways, while also supporting parents in managing their own emotions.
This study aims to examine the feasibility, acceptability, implementation fidelity and efficacy of the TIK program among parents of preschool-aged children in Portugal. TIK is a 6-week group, face-to-face program grounded in the principles of emotion coaching, among other theoretical backgrounds such as Mindfulness and Emotion Regulation Theories.
This trial is a parallel two-arm randomized clinical trial. Participants will be parents/legal guardians (> 18 years old) with at least one child between 3 and 6 years old and with proficiency in portuguese. At least 152 parents/legal guardians will be recruited with the support of several community partners. Interested parents will be contacted by telephone to confirm their eligibility. Participants will be informed about their eligibility during the intake interview, followed by a full explanation of the clinical trial procedures. Eligible participants will be randomly assigned to either the intervention group (TIK) or a waitlist control group, with the latter receiving the intervention after the follow-up assessment. The intervention consists of six weekly in-person group sessions plus one follow-up session, each lasting approximately 2 hours. Participants in both groups will complete questionnaires at three time points - baseline, post-intervention, and 2-month follow-up - covering different dimensions of children (e.g., children's emotional and developmental difficulties) and parental (e.g., parenting stress) psychological functioning, and parenting (e.g., ESPP).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Alves
- Phone Number: +351 21 751 5500
- Email: stephanie.alves@ulusofona.pt
Study Locations
-
-
-
Lisbon, Portugal, 1749-024
- Recruiting
- School of Psychology and Life Sciences, Lusófona University
-
Contact:
- Stephanie Alves
- Phone Number: +351 21 751 5500
- Email: stephanie.alves@ulusofona.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Parents/legal guardians:
- with at least one child aged between 3 and 6 years old (inclusive) who lives with the parent/legal guardian,
- with at least 18 years old,
- who can read, understand, and speak Portuguese
- who live in the Lisbon Metropolitan Area or Lisbon District. When applicable, both parents will be allowed to participate.
Exclusion Criteria:
- parents' poor Portuguese language skills
- parents' being currently enrolled in another structured parenting program
- if the target child is already attending elementary school at the time of recruitment
- if the target child has a diagnosis of a severe Communication and/or Developmental Disorder, or
- if the target child is under a child protection measure that implies that the child does not live with their parents (e.g., if the child is in foster care).
Only participants that give informed consent to participate in the study will be included and randomized to one of the study conditions (TIK vs. waiting list group).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tuning in to Kids® intervention
Participants will attend a 6-week, in-person group program structured around emotion coaching principles (Tuning in to Kids®).
|
Tuning in to Kids® (TIK) is a manualized program delivered by trained facilitators (6 weekly - 2h - group sessions) and aimed to promote parents' emotion socialization practices that are supportive of the child's expression of emotion (emotion coaching; e.g., comforting, teaching constructive means of coping), while reducing unsupportive ESPP (emotion dismissing; e.g., punishing or minimizing).
An additional booster session may be held after two months of program's conclusion.
TIK includes strategies informed by emotion coaching principles, including psychoeducation, roleplays, video materials, mindfulness-based exercises, and group discussions.
By addressing a core mechanism leading to different emotional and behavioral childhood disorders (i.e.
difficulties in emotion regulation), TIK is susceptible to promoting children's long-term full potential and parental mental health outcomes.
|
|
Other: Waiting list group
Participants will be offered and receive TIK after the conclusion of the final follow-up assessment.
|
Tuning in to Kids® (TIK) is a manualized program delivered by trained facilitators (6 weekly - 2h - group sessions) and aimed to promote parents' emotion socialization practices that are supportive of the child's expression of emotion (emotion coaching; e.g., comforting, teaching constructive means of coping), while reducing unsupportive ESPP (emotion dismissing; e.g., punishing or minimizing).
An additional booster session may be held after two months of program's conclusion.
TIK includes strategies informed by emotion coaching principles, including psychoeducation, roleplays, video materials, mindfulness-based exercises, and group discussions.
By addressing a core mechanism leading to different emotional and behavioral childhood disorders (i.e.
difficulties in emotion regulation), TIK is susceptible to promoting children's long-term full potential and parental mental health outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in parents' beliefs about children's emotions
Time Frame: Baseline, immediately post-intervention, and 2 months follow-up
|
Measured with the Parents' Beliefs About Children's Emotions Questionnaire (PBACE).
The PBACE is a 33-item self-report questionnaire, with items rated on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree).
The present study will use the following subscales: Value of Anger, Manipulation, Control, and Autonomy.
Subscale scores will be calculated by averaging item responses, with higher scores indicating stronger endorsement of the corresponding belief in that category.
|
Baseline, immediately post-intervention, and 2 months follow-up
|
|
Changes from baseline in parents' reactions to children's emotions
Time Frame: Baseline, immediately post-intervention, and 2 months follow-up
|
Measured with the Coping with Children's Negative Emotions Scale (CCNES).
The CCNES is a parent-report measure assessing how parents respond to children's negative emotions across 12 hypothetical scenarios, with responses rated on a 7-point Likert scale from 1 (very unlikely) to 7 (very likely).
The CCNES comprises seven subscales: Emotion-Focused, Problem-Focused, Expressive Encouragement, Minimizing, Punitive, Distress, and Ignoring reactions.
Items from the first three subscales are summed to create a composite measure of emotion coaching, whereas items from the remaining four subscales are summed to assess emotion dismissing responses.
For each scale, total scores are calculated by averaging item responses, with higher scores indicating greater endorsement of the corresponding practice.
|
Baseline, immediately post-intervention, and 2 months follow-up
|
|
Changes from baseline in parents' emotion regulation (parenting-specific)
Time Frame: Baseline, immediately post-intervention, and 2 months follow-up
|
Measured with the Interpersonal Mindfulness in Parenting Scale (IM-P).
The IM-P is a 29-item self-report instrument rated on a 5-point Likert scale, from 1 (never true) to 5 (always true).
The Self-Regulation in Parenting will be assessed as primary outcome.
Subscale scores will be calculated by summing item responses.
Higher scores on the Self-Regulation in Parenting subscale indicate greater ability to regulate emotions and behaviors within the parenting context.
|
Baseline, immediately post-intervention, and 2 months follow-up
|
|
Changes from baseline in parents' emotional regulation (general)
Time Frame: Baseline, immediately post-intervention, and 2 month follow-up
|
Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF).
The DERS-SF is a self-report measure, including 18 items, rated on a 5-point Likert scale, ranging from 1 (almost never) to 5 (almost always).
A total score is obtained by averaging all items, with higher scores indicating greater difficulties.
In line with the recommendations of the Portuguese authors, items 1, 4 and 6 will be excluded from the analyses.
|
Baseline, immediately post-intervention, and 2 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in children's behavioral and emotional difficulties
Time Frame: Baseline, immediately post-intervention, and 2 month follow-up
|
Measured with the Strengths and Difficulties Questionnaire - Parent (SDQ-P).
The SDQ-P is a self-report measure for parents, including 25 items, each rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true).
The total difficulties score is calculated by summing the scores from the following subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Relationship Problems.
Higher scores reflect greater difficulties.
The Prosocial Behavior subscale is scored separately, as a measure of strengths.
Two age-specific versions will be presented to parents (for children aged 3-4 and 5-6).
The versions differ slightly in wording, but share the same scoring method and interpretation.
|
Baseline, immediately post-intervention, and 2 month follow-up
|
|
Changes from baseline in children' emotional regulation
Time Frame: Baseline, immediately post-intervention, and 2 month follow-up
|
Measured with the Emotion Regulation Checklist (ERC).
The ERC is a self-report measure consisting of 20 items rated on a 4-point Likert scale, ranging from 1 (never) to 4 (almost always).
The ERC comprises two subscales: Emotion Regulation, and Emotion Lability/Negativity.
For each subscale, a total score is obtained by the sum of the items.
Higher scores on the Emotion Regulation subscale indicate higher emotion regulation; whereas higher scores on the Lability/Negativity subscale indicate higher difficulties in emotion regulation.
|
Baseline, immediately post-intervention, and 2 month follow-up
|
|
Changes from baseline in parenting stress
Time Frame: Baseline, immediately post-intervention, and 2 month follow-up
|
Measured with the Parental Stress Scale (PSS).
The PSS is a self-report scale comprising 18 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree).
A total score is calculated by summing all items, with higher scores reflecting higher levels of parenting stress.
Following the recommendations from the Portuguese authors, items 1-2 and 17-18 will be excluded from the analyses.
|
Baseline, immediately post-intervention, and 2 month follow-up
|
|
Changes from baseline in depressive symptoms
Time Frame: Baseline, immediately post-intervention, and 2 month follow-up
|
Measured with the Depressive Symptoms subscale of the Hospital Anxiety and Depression Scale (HADS).
This subscale consists of 7 items rated on a 4-point Likert scale, from 0 to 3 (e.g., "not at all", "most of the time").
The total score is obtained by summing the scores of the items, with higher scores being indicative of higher levels of depressive symptoms.
|
Baseline, immediately post-intervention, and 2 month follow-up
|
|
Changes from baseline in parenting self-efficacy
Time Frame: Baseline, immediately post-intervention, and 2 month follow-up
|
Measured with the Self-Efficacy subscale of the Me as a Parent Questionnaire (MaaP).
This subscale consists of 4 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree).
A total score is obtained by adding up the items, with higher scores reflecting higher levels of perceived self-efficacy.
|
Baseline, immediately post-intervention, and 2 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: Immediately post-intervention
|
Measured using a 16-item Likert-scale questionnaire developed by the research team; scores ranging from 1 (not at all) to 5 (very much).
The questionnaire evaluates: (1) overall satisfaction with TIK; (2) the extent to which TIK met parents' expectations and contributed to improvements in parents' self-confidence, parent-child relationships, children's well-being, and parents' ability to understand and manage their children's emotions; (3) the frequency of applying TIK strategies in daily interactions; (4) the adequacy of the number, length and frequency of sessions; (5) satisfaction with the group format; (6) perceptions of facilitator competence and the intervention facilities; and (7) the perceived long-term usefulness of the acquired strategies.
Participants will also indicate whether they would recommend the program to other parents (yes/no) and rate the ease of understanding and applying emotion coaching strategies on a scale from 1 (very easy) to 5 (very difficult)
|
Immediately post-intervention
|
|
Feasibility of the intervention
Time Frame: Immediately post-intervention
|
Measured by participant adherence to the sessions, and facilitators and barriers to implementation.
Adherence is measured by session attendance, with completion defined as attending at least 4 out of 6 sessions (i.e., 67%).
Participants missing sessions will be contacted to identify barriers to participation.
Regardless of completion, all participants will report factors that helped or hindered participation.
Dropouts will be contacted to determine specific reasons, and the timing of dropout will be recorded.
Overall attrition will be measured by the number of participants not completing post-intervention and/or follow-up assessments.
|
Immediately post-intervention
|
|
Implementation fidelity of the intervention
Time Frame: During the intervention (at the end of each session).
|
Both facilitators and an independent observer (present in all groups) will complete the TIK Program Fidelity Checklist.
For each planned activity outlined in the intervention manual, they will indicate whether the content was delivered as intended, with space provided for additional comments or notes.
|
During the intervention (at the end of each session).
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TIK-PT/FCG/335706
- FCG/Growing Minds/335706 (Other Grant/Funding Number: Fundação Calouste Gulbenkian)
- UID/05380/2025 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parental Emotion Socialization
-
Karolinska InstitutetThe Swedish Research Council; Region StockholmActive, not recruitingStress, Emotional | Coping Behavior | Emotion Regulation | Parental Support | CoparentingSweden
-
Children's Hospital Los AngelesCompletedChild Development | School Readiness | Racial SocializationUnited States
-
McGill UniversityUniversity of Manitoba; Social Sciences and Humanities Research Council of...RecruitingParental Stress | Child Development | Child Mental Disorder | Maternal Depression | Self-Regulation, Emotion | Attention Problems | Behaviour ProblemsCanada
-
University of NottinghamNot yet recruitingParental ImprisonmentUnited Kingdom
-
Children's Mercy Hospital Kansas CityCompleted
-
Universiteit AntwerpenKU Leuven; OpgroeienNot yet recruitingParental Stress | Infant Regulatory Problems | Regulatory Problems in Infancy | Parental Self-efficacyBelgium
-
Massachusetts General HospitalRobert Wood Johnson FoundationCompletedTobacco Use | Parental SmokingUnited States
-
University of ChicagoCompleted
-
University of CopenhagenKøbenhavns Kommune; Aarhus Kommune; Hvidovre Kommune; Horsholm Municipality; Samarbejde... and other collaboratorsRecruitingParental Divorce | Parental Relationship Dissolution | Mental Health and Well-beingDenmark
-
Centre Hospitalier Universitaire DijonCompletedExpanded Newborn Screening | Parental AcceptabilityFrance
Clinical Trials on Tuning in to Kids®
-
University of OsloActive, not recruitingParent and Child Emotional Intelligence and Child Self-regulationNorway
-
Children's Hospital Medical Center, CincinnatiCompletedHeart Defects, Congenital | Parenting | Emotion RegulationUnited States
-
University of OsloActive, not recruiting
-
The University of Hong KongCompletedADHD | Emotion Regulation | Parenting InterventionHong Kong
-
University of OsloCompleted
-
Sophie HavighurstUniversity of Melbourne; University of StavangerEnrolling by invitation
-
University Hospital, AkershusUniversity of Oslo; University of Melbourne; ExtrastiftelsenTerminated
-
University of RochesterNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes...CompletedFetal Alcohol Spectrum DisordersUnited States
-
St. Jude Children's Research HospitalNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSickle Cell DiseaseUnited States
-
Oregon Social Learning CenterU.S. Department of EducationCompletedSchool ReadinessUnited States