Parental Emotion SocializationTIK-PTNCT07350083
Tuning in to Kids® for Parents of Preschool-aged Children in Portugal
A study testing Tuning in to Kids® in people with Parental Emotion Socialization and Parents' Beliefs About and Reactions to Children's Emotions, run by Lusofona University at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parental Emotion Socialization, Parents' Beliefs About and Reactions to Children's Emotions, Parental Emotion 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
- 152 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Dec 2025to 30 Sep 2027
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
School of Psychology and Life Sciences, Lusófona University
Lisbon, 1749-024
Stephanie Alves, +351 21 751 5500, stephanie.alves@ulusofona.pt
About this study
Official title: 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).
- Conditions
- Parental Emotion Socialization, Parents' Beliefs About and Reactions to Children's Emotions, Parental Emotion Regulation
- Being tested
- Tuning in to Kids®
- Keywords
- Tuning in to Kids®, parental emotion socialization, randomized controlled trial, preschool, children emotional and behavioral difficulties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuning in to Kids®Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tuning in to Kids® intervention | Experimental | Participants will attend a 6-week, in-person group program structured around emotion coaching principles (Tuning in to Kids®). Receives: Behavioral: Tuning in to Kids® |
| Waiting list group | Other | Participants will be offered and receive TIK after the conclusion of the final follow-up assessment. Receives: Behavioral: Tuning in to Kids® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in parents' beliefs about children's emotions
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.
Measured: Baseline, immediately post-intervention, and 2 months follow-up
Changes from baseline in parents' reactions to children's emotions
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.
Measured: Baseline, immediately post-intervention, and 2 months follow-up
Changes from baseline in parents' emotion regulation (parenting-specific)
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.
Measured: Baseline, immediately post-intervention, and 2 months follow-up
Changes from baseline in parents' emotional regulation (general)
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.
Measured: Baseline, immediately post-intervention, and 2 month follow-up
Secondary outcomes (5)
Changes from baseline in children's behavioral and emotional difficulties
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.
Measured: Baseline, immediately post-intervention, and 2 month follow-up
Changes from baseline in children' emotional regulation
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.
Measured: Baseline, immediately post-intervention, and 2 month follow-up
Changes from baseline in parenting stress
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.
Measured: Baseline, immediately post-intervention, and 2 month follow-up
Changes from baseline in depressive symptoms
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.
Measured: Baseline, immediately post-intervention, and 2 month follow-up
Changes from baseline in parenting self-efficacy
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.
Measured: Baseline, immediately post-intervention, and 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start2 Dec 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parental Emotion SocializationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lusofona University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa da Misericórdia de Lisboa, Aventura Social, NucliSol Jean Piaget, Pressley Ridge, Associação Nacional de Apoio ao Desenvolvimento, Investigação e Comunidade, Instituto Belong - Desenvolvimento e Saúde, Associação de Aldeias de Crianças SOS, Associação Passo a Passo, CPCJ da Amadora, Centro Hospitalar Lisboa Ocidental, Instituto de Apoio à Criança, MSV - Crescer Como Família, Unidade Local de Saúde Amadora-Sintra, Comissão Nacional de Promoção dos Direitos e Proteção das Crianças e Jovens, Calouste Gulbenkian Foundation, Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Stephanie Alves, Lusofona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350083
- Sponsor's protocol ID
- TIK-PT/FCG/335706
- Other IDs
- FCG/Growing Minds/335706, UID/05380/2025
- Acronym
- TIK-PT
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Collective results from this trial will be shared to scientific and non-scientific communities after its conclusion.
Publications
Alves S, Faria M, Pinto TM, Cruz AR, Sousa C, Beato A, Albuquerque SM, Dias V, Jongenelen I, Lamela D, Costa R, Pires R. Tuning in to Kids(R) for parents of preschool-aged children in Portugal: study protocol for a randomized controlled trial. BMC Psychol. 2026 Apr 16;14(1):795. doi: 10.1186/s40359-026-04450-4.
PubMed 41987342
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Parental and Child Mental Health Through Emotion-focused Parenting Programs: Adaptation, Implementation, and Evaluation of Tuning in to Kids® in Portugal
- ClinicalTrials.gov ID
- NCT07350083
- Acronym / sponsor ID
- TIK-PT / TIK-PT/FCG/335706
- Conditions
- Parental Emotion Socialization, Parents' Beliefs About and Reactions to Children's Emotions, Parental Emotion Regulation
- Keywords
- Tuning in to Kids®, parental emotion socialization, randomized controlled trial, preschool, children emotional and behavioral difficulties
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Lusofona UniversityUniversity, hospital or other
- Collaborators
- Santa Casa da Misericórdia de Lisboa, Aventura Social, NucliSol Jean Piaget, Pressley Ridge, Associação Nacional de Apoio ao Desenvolvimento, Investigação e Comunidade, Instituto Belong - Desenvolvimento e Saúde, Associação de Aldeias de Crianças SOS, Associação Passo a Passo, CPCJ da Amadora, Centro Hospitalar Lisboa Ocidental, Instituto de Apoio à Criança, MSV - Crescer Como Família, Unidade Local de Saúde Amadora-Sintra, Comissão Nacional de Promoção dos Direitos e Proteção das Crianças e Jovens, Calouste Gulbenkian Foundation, Fundação para a Ciência e a Tecnologia
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuning in to Kids® intervention | Experimental | Behavioral: Tuning in to Kids®Participants will attend a 6-week, in-person group program structured around emotion coaching principles (Tuning in to Kids®). |
| Waiting list group | Other | Behavioral: Tuning in to Kids®Participants will be offered and receive TIK after the conclusion of the final follow-up assessment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
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 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. | Behavioural | Tuning in to Kids® intervention, Waiting list group |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Changes from baseline in children's behavioral and emotional difficulties
Time frame: 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
Changes from baseline in parenting stress
Time frame: 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
Changes from baseline in parenting self-efficacy
Time frame: Baseline, immediately post-intervention, and 2 month follow-up
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 20 Jan 2026.
- Derived from this study: PubMed 41987342Alves S, Faria M, Pinto TM, Cruz AR, Sousa C, Beato A, Albuquerque SM, Dias V, Jongenelen I, Lamela D, Costa R, Pires R. Tuning in to Kids(R) for parents of preschool-aged children in Portugal: study protocol for a randomized controlled trial. BMC Psychol. 2026 Apr 16;14(1):795. doi: 10.1186/s40359-026-04450-4.
- Individual participant dataSharing planned: No. Collective results from this trial will be shared to scientific and non-scientific communities after its conclusion.
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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.
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 Parental Emotion Socialization and Parents' Beliefs About and Reactions to Children's Emotions, run by Lusofona University at 1 site in Portugal.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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 Portugal. 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?
Contact Stephanie Alves (+351 21 751 5500, stephanie.alves@ulusofona.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in parents' beliefs about children's emotions (time frame: Baseline, immediately post-intervention, and 2 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07350083, which also lists 1 linked publication.
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 20 Jan 2026.