Infant Regulatory ProblemsNCT07541716
Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties
A study testing Structured early parenting support program, called "Eat, sleep, cry - repeat" in people with Infant Regulatory Problems and Regulatory Problems in Infancy, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infant Regulatory Problems, Regulatory Problems in Infancy, Parental Stress
- What is being tested?
- Structured early parenting support program, called "Eat, sleep, cry - repeat"
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 6 May 2026to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent (or primary caregiver) of an infant aged approximately 3 months at enrollment.
- Aged 18 years or older.
- One parent has completed the brief screening questionnaire and scored above a predefined cutoff indicating elevated levels of infant regulatory problems and eligibility for the intervention.
Who cannot join
- Insufficient proficiency in Dutch to understand study materials or participate in intervention sessions
- No access to the internet or a compatible device required to use the mobile application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara De Bruyn contact
About this study
The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems.
The main questions this study aims to answer are:
Read more
- Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention?
- Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)?
Researchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention.
Participants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old.
If assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.
- Conditions
- Infant Regulatory Problems, Regulatory Problems in Infancy, Parental Stress, Parental Self-efficacy
- Being tested
- Structured early parenting support program, called "Eat, sleep, cry - repeat"
- Keywords
- Early infancy, Infant regulatory problems, Parental well-being, Parenting support, Behavioral intervention, Family intervention, Parent-infant relationship, Randomized controlled trial, Psychoeducation, Regulatory problems in infancy, Infant mental health, Parent-infant mental health, Parental stress, Parental self-efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured early parenting support program, called "Eat, sleep, cry - repeat"Behavioural
The program includes one individual session with a trained psycho-educator, five group sessions (two in person, three online), and access to a digital support tool via a mobile application. Sessions provide psycho-education, discussion, reflection, and peer support. The modules in the app address early regulatory difficulties such as excessive crying, feeding, or sleep problems, as well as other themes such as social support and the partner relationship. In the group sessions, the psycho-educators will refer to and expand on the app materials, allowing for deeper discussion and personalization of the content in line with the needs and questions of participating families.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants assigned to this condition will receive the six-week intervention program. They complete questionnaires during the 12-month study period. Receives: Behavioral: Structured early parenting support program, called "Eat, sleep, cry - repeat" |
| Control arm | No intervention | Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the intervention. Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the structured parenting intervention. Participants receive care as usual, consisting of standard preventive child health care provided by routine services (e.g., monitoring of growth, development, and vaccinations). Additional support may be provided if concerns arise, but no structured intervention targeting regulatory problems is systematically offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS), from baseline to post-intervention
Parental self-efficacy as measured by the Karitane Parenting Confidence Scale. Scores range from 0 to 45, with higher scores indicating greater parental self-efficacy.
Measured: Post-intervention (infant age approximately 6 months)
Changes in parental stress, as measured by the Parental Stress Scale (PSS; parental stress factor), from baseline to post-intervention
Parental stress as measured by the Parental Stress Scale (PSS). Based on the Dutch validation, a 15-item version with a two-factor structure is used, of which only the parental stress factor (9 items) is included in this study. Scores range from 5 to 45, with higher scores indicating higher levels of parental stress.
Measured: Post-intervention (infant age approximately 6 months)
Infant regulatory problems at 6-month follow-up (infant age approximately 12 months)
Infant regulatory problems as measured by a study-specific parent-report questionnaire assessing difficulties in domains such as crying, sleeping, and feeding. Responses are rated on a 5-point Likert scale, with higher scores indicating more regulatory problems.
Measured: 6 months follow-up (infant age approximately 12 months)
Secondary outcomes (12)
Changes in parental stress over time, as measured by the Parental Stress Scale (PSS; parental stress factor)
Parental stress as measured by the parental stress factor of the PSS, consisting of 9 items. Scores range from 5 to 45, with higher scores indicating higher levels of parental stress.
Changes are assessed across all time points, including intervention effects and their maintenance over time.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS)
Parental self-efficacy as measured by the KPCS. Scores range from 0 to 45, with higher scores indicating greater parenting confidence.
Changes are assessed across all time points, including intervention effects and their maintenance over time.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in infant regulatory problems over time
Infant regulatory problems as measured by a study-specific parent-report questionnaire assessing difficulties in domains such as crying, sleeping, and feeding. Responses are rated on a 5-point Likert scale, with higher scores indicating more regulation problems.
Changes are assessed across all time points, including intervention effects and their maintenance over time.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 9 and 12 months)
Changes in parental self-regulation over time
Parental self-regulation as assessed by two study-specific self-report items, rated on a 0-10 Likert scale. Higher scores indicate lower levels of parental self-regulation.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental co-regulation over time
Parental co-regulation as measured by three study-specific items assessing the parent's ability to support the child's emotional regulation. Items are rated on a 1-4 Likert scale, with higher scores indicating better parental co-regulation.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in perceived social support over time
Perceived social support, as measured by four study-specific items, rated on a 0-10 Likert scale. Higher scores indicate higher levels of perceived social support.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental reflective functioning, as measured by the parental reflective functioning questionnaire (PRFQ)
Parental reflective functioning as measured by the Interest \& Curiosity (IC) and Certainty about Mental states (CMS) subscales of the PRFQ. CM assesses parents' confidence in understanding their child's mental states, while IC assesses active interest in and curiosity about the child's mental states. Items are scored on a 7-point Likert scale (1-7). Subscale scores are calculated by summing the item responses, with total scores for each subscale ranging from 7 to 42. For both subscales, higher scores indicate higher levels of the respective construct, however, extremely high or low scores may reflect maladaptive patterns (e.g., hypermentalizing or hypomentalizing).
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in anxiety symptoms over time, as measured by the Generalized Anxiety Disorder scale (GAD-7)
Anxiety symptoms as measured by the Generalized Anxiety Disorder scale (GAD-7). Items are rated on a 4-point Likert scale (0-3). Total scores range from 0 to 21, with higher scores indicating higher levels of anxiety symptoms.
Changes are assessed across all time points, including intervention effects and their maintenance over time.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in depressive symptoms over time, as measured by the Center of Epidemiologic Studies Depression Scale (CES-D 8).
Depressive symptoms as measured by the CES-D 8. Items are rated on a 4-point Likert scale (0-3). Total scores range from 0 to 24, with higher scores indicating higher levels of depressive symptoms.
Changes are assessed across all time points, including intervention effects and their maintenance over time.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in partner relationship satisfaction over time
Partner relationship satisfaction as measured by three study-specific items assessing partner support during stressful situations. Items are rated on a 1-4 Likert scale, with higher scores indicating greater perceived support and satisfaction in the relationship.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Child socio-emotional development at 6-month follow-up (infant age approximately 12 months)
Child socio-emotional development as measured by a 9-item parent-report questionnaire based on criteria from de Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood (DC:0-5). Items are rated on a 5-point Likert scale (1-5). Total scores range from 9 to 45, with higher scores indicating better socio-emotional development.
Measured: 6 months follow-up (infant age approximately 12 months)
Changes in parent-infant bonding, as measured by the Postpartum Bonding Questionnaire (PBQ)
Parent-infant bonding, as measured by the PBQ, a questionnaire consisting of 25 items. Items are rated on a 6-point Likert scale (0-5). Total scores range from 0 to 125, with higher scores indicating more impaired parent-infant bonding.
Changes are assessed across all time points, including intervention effects and their maintenance over time.
Measured: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start6 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infant Regulatory ProblemsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Opgroeien
- Responsible party
- Principal investigator, Edwin Wouters, Universiteit Antwerpen
- Investigators
- Edwin Wouters, Prof. Dr., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541716
- Sponsor's protocol ID
- Antigoon ID48645
- Other IDs
- S003524N
- Status last verified
- Jun 2026
- First submitted
- 9 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing individual participant data (IPD) has not yet been finalized. The study team will consider data sharing options after study completion, taking into account participant privacy, ethical approvals, and potential collaborations with other researchers.
Publications
Crncec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health. 2008 Oct;31(5):442-53. doi: 10.1002/nur.20271.
PubMed 18297638van der Knoop, M., Schmidt, L., & Jansson, B. (2023). Translation and psychometric properties of the Dutch Parental Stress Scale. 7, 84-99.
Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial Psychometric Evidence. Journal of Social and Personal Relationships, 12(3), 463-472. https://doi.org/10.1177/0265407595123009
Luyten, P., Nijssens, L., Fonagy, P., & Mayes, L. C. (2017). Parental Reflective Functioning: Theory, Research, and Clinical Applications. The Psychoanalytic Study of the Child, 70(1), 174-199. https://doi.org/10.1080/00797308.2016.1277901
Van de Velde, S., Levecque, K., & Bracke, P. (2009). Measurement equivalence of the CES-D 8 in the general population in Belgium: A gender perspective. Archives of Public Health, 67(1), 15-29. https://doi.org/10.1186/0778-7367-67-1-15
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties
- ClinicalTrials.gov ID
- NCT07541716
- Acronym / sponsor ID
- Antigoon ID48645
- Conditions
- Infant Regulatory Problems, Regulatory Problems in Infancy, Parental Stress, Parental Self-efficacy
- Keywords
- Early infancy, Infant regulatory problems, Parental well-being, Parenting support, Behavioral intervention, Family intervention, Parent-infant relationship, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- KU Leuven, Opgroeien
- Study start
- 6 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Apr 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.
The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems.
The main questions this study aims to answer are:
- Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention?
- Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)?
Researchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention.
Participants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old.
If assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Structured early parenting support program, called "Eat, sleep, cry - repeat"Participants assigned to this condition will receive the six-week intervention program. They complete questionnaires during the 12-month study period. |
| Control arm | No intervention | –Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the intervention. Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the structured parenting intervention. Participants receive care as usual, consisting of standard preventive child health care provided by routine services (e.g., monitoring of growth, development, and vaccinations). Additional support may be provided if concerns arise, but no structured intervention targeting regulatory problems is systematically offered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent (or primary caregiver) of an infant aged approximately 3 months at enrollment.
- Aged 18 years or older.
- One parent has completed the brief screening questionnaire and scored above a predefined cutoff indicating elevated levels of infant regulatory problems and eligibility for the intervention.
Key exclusion criteria (2 listed)
- Insufficient proficiency in Dutch to understand study materials or participate in intervention sessions
- No access to the internet or a compatible device required to use the mobile application
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 |
|---|---|---|
| Structured early parenting support program, called "Eat, sleep, cry - repeat"The program includes one individual session with a trained psycho-educator, five group sessions (two in person, three online), and access to a digital support tool via a mobile application. Sessions provide psycho-education, discussion, reflection, and peer support. The modules in the app address early regulatory difficulties such as excessive crying, feeding, or sleep problems, as well as other themes such as social support and the partner relationship. In the group sessions, the psycho-educators will refer to and expand on the app materials, allowing for deeper discussion and personalization of the content in line with the needs and questions of participating families. | Behavioural | Intervention arm |
Primary outcome
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS), from baseline to post-intervention
Time frame: Post-intervention (infant age approximately 6 months)
Parental self-efficacy as measured by the Karitane Parenting Confidence Scale. Scores range from 0 to 45, with higher scores indicating greater parental self-efficacy.
Changes in parental stress, as measured by the Parental Stress Scale (PSS; parental stress factor), from baseline to post-intervention
Time frame: Post-intervention (infant age approximately 6 months)
Parental stress as measured by the Parental Stress Scale (PSS). Based on the Dutch validation, a 15-item version with a two-factor structure is used, of which only the parental stress factor (9 items) is included in this study. Scores range from 5 to 45, with higher scores indicating higher levels of parental stress.
Infant regulatory problems at 6-month follow-up (infant age approximately 12 months)
Time frame: 6 months follow-up (infant age approximately 12 months)
Infant regulatory problems as measured by a study-specific parent-report questionnaire assessing difficulties in domains such as crying, sleeping, and feeding. Responses are rated on a 5-point Likert scale, with higher scores indicating more regulatory problems.
12 secondary outcomes
Changes in parental stress over time, as measured by the Parental Stress Scale (PSS; parental stress factor)
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS)
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in infant regulatory problems over time
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 9 and 12 months)
Changes in parental self-regulation over time
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental co-regulation over time
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in perceived social support over time
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental reflective functioning, as measured by the parental reflective functioning questionnaire (PRFQ)
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in anxiety symptoms over time, as measured by the Generalized Anxiety Disorder scale (GAD-7)
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in depressive symptoms over time, as measured by the Center of Epidemiologic Studies Depression Scale (CES-D 8).
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in partner relationship satisfaction over time
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Child socio-emotional development at 6-month follow-up (infant age approximately 12 months)
Time frame: 6 months follow-up (infant age approximately 12 months)
Changes in parent-infant bonding, as measured by the Postpartum Bonding Questionnaire (PBQ)
Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
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 9 Jun 2026.
- Background: PubMed 18297638Crncec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health. 2008 Oct;31(5):442-53. doi: 10.1002/nur.20271.
- Backgroundvan der Knoop, M., Schmidt, L., & Jansson, B. (2023). Translation and psychometric properties of the Dutch Parental Stress Scale. 7, 84-99.
- BackgroundBerry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial Psychometric Evidence. Journal of Social and Personal Relationships, 12(3), 463-472. https://doi.org/10.1177/0265407595123009
- BackgroundLuyten, P., Nijssens, L., Fonagy, P., & Mayes, L. C. (2017). Parental Reflective Functioning: Theory, Research, and Clinical Applications. The Psychoanalytic Study of the Child, 70(1), 174-199. https://doi.org/10.1080/00797308.2016.1277901
- BackgroundVan de Velde, S., Levecque, K., & Bracke, P. (2009). Measurement equivalence of the CES-D 8 in the general population in Belgium: A gender perspective. Archives of Public Health, 67(1), 15-29. https://doi.org/10.1186/0778-7367-67-1-15
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing individual participant data (IPD) has not yet been finalized. The study team will consider data sharing options after study completion, taking into account participant privacy, ethical approvals, and potential collaborations with other researchers.
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.
Sara De Bruyn contact
Edwin Wouters, Prof. Dr. principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured early parenting support program, called "Eat, sleep, cry - repeat" in people with Infant Regulatory Problems and Regulatory Problems in Infancy, run by Universiteit Antwerpen at 1 site in Belgium.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Jun 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 Belgium. 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 Fien Plochaet (+3232652016, fien.plochaet@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS), from baseline to post-intervention (time frame: Post-intervention (infant age approximately 6 months)). The study lists 3 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 NCT07541716, which also lists 6 linked publications.
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 9 Jun 2026.