Parent-Child RelationsSAF-ParentsNCT07153198
Promoting Socioemotional Development in Early Childhood: Implementation and Evaluation of the VIPP-SD Parenting Intervention in Portugal
A study testing VIPP-SD in people with Parent-Child Relations, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
Trial summary
The Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) is an attachment-based intervention aimed at promoting parental sensitivity and the use of developmentally appropriate, non-coercive discipline strategies (ref). Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- VIPP-SD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2026to 31 Dec 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: Children will be between 2 and 6 years old, and their parents between must be fluent in Portuguese -
Exclusion Criteria: Children with disabilities, chronic illnesses, or hereditary diseases will be excluded from the study
-
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
Manuela Verissimo
Lisbon, Lisbon District, 2795-233
Manuela Verissimo, PhD, 911194820, mveriss@ispa.pt
About this study
The Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) is an attachment-based intervention aimed at promoting parental sensitivity and the use of developmentally appropriate, non-coercive discipline strategies (ref). The VIPP-SD intervention integrates the enhancement of parental sensitive responsiveness (Ainsworth et al., 1974) with parent coaching aimed at preventing coercive parent-child interaction cycles (Patterson, 1982) and facilitating sensitive limit-setting practices.ase parental sensitivity and sensitive discipline of the primary parent
Read the detailed description
Aims and hypotheses
- The primary aim of the Growing Minds - Strengthening Affective Bonds is to demonstrate the effect of the VIPP-SD on parental sensitivity and sensitive discipline of the primary parent, 8 weeks after the intervention and six months after the intervention. It is expected that sensitivity and sensitive discipline of parents in the intervention condition will significantly increase post-intervention, compared to sensitivity and sensitive discipline of parents in the control condition, who have a similar number of ('dummy') contacts with the interveners.
- The secondary aim of the study is to examine the efficacy of the intervention in reducing children's behavioral problems, as a function of increased parental sensitivity and the use of sensitive discipline strategies. It is expected that improvements in parenting behaviors resulting from the VIPP-SD intervention will be associated with lower levels of behavioral difficulties in children over time.
- A third objective of the study is to evaluate the impact of the intervention on broader parenting practices and parental well-being, specifically aiming to mitigate psychopathological symptomatology. The focus will be on reducing symptoms of depression and anxiety among participating parents, in line with evidence suggesting that improvements in parenting sensitivity may contribute to enhanced parental mental health.
- Finally, the investigators will examine whether the intervention yields economic advantages for society at large. To do this, the investigators will use quality-adjusted life-years (QALYs) as the unit of outcome, allowing to quantify health benefits. By comparing the QALYs associated with the intervention to those resulting from no intervention, the investigators aim to assess the cost-effectiveness and potential return on investment from a societal perspective. This analysis will help determine whether the intervention not only improves family relations but also contributes to economic efficiency by potentially reducing healthcare costs, improving productivity, and enhancing overall societal well-being
- Conditions
- Parent-Child Relations
- Being tested
- VIPP-SD
- Keywords
- sensitivity, attachment, behavioral problems, economic advantages
- Medical subject headings
- Hypersensitivity, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPP-SDOther
Consists of four sessions (with the option of one or two additional booster sessions), held biweekly, depending on the family's needs and availability. Specifically, VIPP-SD addresses disciplinary strategies alongside sensitivity themes through: (1) the differentiation between attachment and exploration behaviors; interpretation of child's behavior and significance of a sensitive response to it; and the importance of sharing emotions (2) the application of distraction and induction as non-coercive techniques in response to challenging child behaviours or conflict-prone situations; (3) the utilization of positive reinforcement, whereby parents praise adaptive behaviours and ignore maladaptive, attention-seeking actions; (4) the implementat of a sensitive interaction pause to de-escalate conflict or temper tantrums; and (5) the demonstration of empathy towards the child in conjunction with consistent disciplinary approaches and explicit boundary-setting
| Study group | Role | What they receive |
|---|---|---|
| Intervention with VIPP-SD | Active comparator | Intervention group: Receives: Other: VIPP-SD |
| Control Group: No intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental sensitivity: Erickson Scales of Parental Sensitivity (ESPS, Egeland, et al., 1990)
Parental sensitivity will be assessed using the the revised Erickson 7-point rating scales for Supportive Presence (from 1 = parent completely fails to be supportive to the child to 7 = parent skilfully provides support throughout the session) and Intrusiveness (from 1 = parent allows the child sufficient time to explore and to attempt to solve tools on her/his own to 7 = parent is highly intrusive; her agenda clearly has precedence over the child's wishes; Egeland et al., 1990). Supportive presence is defined as the consistent emotional, physical, and psychological availability of a mother, characterized by both verbal expressions and nonverbal behaviors. High sensitivity is associated with positive developmental outcomes in children, including secure attachment and better emotional regulation. Intrusiveness reflects the extent to which a parent disregards or interferes with the child's autonomy, wishes, interests, or behaviors.
Measured: Data will be collected at pretest, posttest (14 weeks) .
Secondary outcomes (5)
Strengths & Difficulties Questionnaire" (SDQ Portuguese version Fleitlich et al., 2004)
The assessment tool used in this study is a 25-item questionnaire designed to evaluate emotional and behavioral problems in children aged 2 to 17 years, with responses provided by parents. The items are rated on a 3-point scale: 0 = "Not true," 1 = "A bit true," and 2 = "Very true." The questionnaire is structured into five subscales: (1) emotional symptoms, (2) conduct problems, (3) hyperactivity, (4) peer problems, and (5) prosocial behavior. For this study, only the parent version of the questionnaire is utilized. The total difficulties score is derived by summing the first four subscales (excluding prosocial behavior), yielding a score ranging from 0 to 40.
Measured: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Depression, Anxiety, and Stress Scale - 21 (DASS-21)
The Depression, Anxiety, and Stress Scale - 21 (DASS-21; Lovibond \& Lovibond, 1995; Portuguese version: Apóstolo et al., 2006) is a 21-item self-report questionnaire designed to assess symptoms of depression, anxiety, and stress in parents. Each item is rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me most of the time). The scale comprises three subscales: Depression (7 items), which assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest or involvement, anhedonia, and inertia; Anxiety (7 items), which measures autonomic arousal, skeletal muscle effects, situational anxiety, and the subjective experience of anxious affect; Stress (7 items), which evaluates chronic, nonspecific arousal, including difficulty relaxing, nervous arousal, irritability, agitation, and impatience. Subscale and total scores are calculated by summing the item responses.
Measured: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
AQOL-8D (Richardson & Lezzi, 2014)
Quality of life among caregivers will be measured with the Assessing Quality of Life - 8 Dimensions (AQOL-8D) (Richardson \& Lezzi, 2014) is a multi-attribute utility instrument developed to provide a sensitive and comprehensive assessment of health status among adults across eight dimensions,, including independent living, mental health, coping, relationships, pain, self-worth, happiness and senses) and 35 items with four to six response levels, each representing increasing levels of severity. This measure will be used for economic evaluation.
Measured: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Resource Use Characterization Questionnaire.
Resources used by children and their parents will be measured using a questionnaire adapted from published questionnaires by Bouwmans et al, 2013 and Pokhilenko et al. 2023. Resource use will include healthcare services (accident and emergency visits, primary care and specialized outpatient visits and inpatient stays, medication), social services, transportation, absenteeism and presenteeism from both paid and unpaid work, and out-of-pocket expenses. This measure will be used for economic evaluation.
Measured: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Child Rearing Practices Report-Questionnaire (CRPR-Q)
The Child Rearing Practices Report-Questionnaire (CRPR-Q; Rickel \& Biasatti, 1982, Ribeiro et al, 2021) is a 40-item parent-report questionnaire used to assess parenting practices that are theoretically and empirically linked to child developmental outcomes. Parents are instructed to respond with reference to a specific child in the household, rating each item on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The measure comprises two theoretically grounded subscales: Nurturance and Restrictiveness
Measured: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 Parent-Child RelationsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Manuela Pedro Veríssimo, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Investigators
- Manuela Verissimo, PhD, Principal investigator, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153198
- Sponsor's protocol ID
- I-011-04-25
- Other IDs
- Grant nº 325160
- Acronym
- SAF-Parents
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Intellectual Property Data (IPD) might not be shared due to concerns about confidentiality and legal restrictions. Sharing it could risk exposing proprietary or sensitive information, including details that may affect entire family's privacy.
Publications
Verissimo M, Guedes M, Fernandes M, Fernandes C, Santos C, Diniz E, Oliveira P, Negrao M, Sampaio F, Bakermans-Kranenburg M. Promoting socioemotional development in early childhood: implementation and evaluation of the VIPP-SD parenting intervention in Portugal. BMC Psychol. 2025 Oct 29;13(1):1190. doi: 10.1186/s40359-025-03431-3.
PubMed 41163103
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Socioemotional Development in Early Childhood: Implementation and Evaluation of the VIPP-SD Parenting Intervention in Portugal
- ClinicalTrials.gov ID
- NCT07153198
- Acronym / sponsor ID
- SAF-Parents / I-011-04-25
- Conditions
- Parent-Child Relations
- Keywords
- sensitivity, attachment, behavioral problems, economic advantages
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da VidaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Sep 2025 (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 Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) is an attachment-based intervention aimed at promoting parental sensitivity and the use of developmentally appropriate, non-coercive discipline strategies (ref). The VIPP-SD intervention integrates the enhancement of parental sensitive responsiveness (Ainsworth et al., 1974) with parent coaching aimed at preventing coercive parent-child interaction cycles (Patterson, 1982) and facilitating sensitive limit-setting practices.ase parental sensitivity and sensitive discipline of the primary parent
Detailed description
Aims and hypotheses
- The primary aim of the Growing Minds - Strengthening Affective Bonds is to demonstrate the effect of the VIPP-SD on parental sensitivity and sensitive discipline of the primary parent, 8 weeks after the intervention and six months after the intervention. It is expected that sensitivity and sensitive discipline of parents in the intervention condition will significantly increase post-intervention, compared to sensitivity and sensitive discipline of parents in the control condition, who have a similar number of ('dummy') contacts with the interveners.
- The secondary aim of the study is to examine the efficacy of the intervention in reducing children's behavioral problems, as a function of increased parental sensitivity and the use of sensitive discipline strategies. It is expected that improvements in parenting behaviors resulting from the VIPP-SD intervention will be associated with lower levels of behavioral difficulties in children over time.
- A third objective of the study is to evaluate the impact of the intervention on broader parenting practices and parental well-being, specifically aiming to mitigate psychopathological symptomatology. The focus will be on reducing symptoms of depression and anxiety among participating parents, in line with evidence suggesting that improvements in parenting sensitivity may contribute to enhanced parental mental health.
- Finally, the investigators will examine whether the intervention yields economic advantages for society at large. To do this, the investigators will use quality-adjusted life-years (QALYs) as the unit of outcome, allowing to quantify health benefits. By comparing the QALYs associated with the intervention to those resulting from no intervention, the investigators aim to assess the cost-effectiveness and potential return on investment from a societal perspective. This analysis will help determine whether the intervention not only improves family relations but also contributes to economic efficiency by potentially reducing healthcare costs, improving productivity, and enhancing overall societal well-being
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with VIPP-SD | Active comparator | Other: VIPP-SDIntervention group: |
| Control Group: No intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| VIPP-SDConsists of four sessions (with the option of one or two additional booster sessions), held biweekly, depending on the family's needs and availability. Specifically, VIPP-SD addresses disciplinary strategies alongside sensitivity themes through: (1) the differentiation between attachment and exploration behaviors; interpretation of child's behavior and significance of a sensitive response to it; and the importance of sharing emotions (2) the application of distraction and induction as non-coercive techniques in response to challenging child behaviours or conflict-prone situations; (3) the utilization of positive reinforcement, whereby parents praise adaptive behaviours and ignore maladaptive, attention-seeking actions; (4) the implementat of a sensitive interaction pause to de-escalate conflict or temper tantrums; and (5) the demonstration of empathy towards the child in conjunction with consistent disciplinary approaches and explicit boundary-setting | Other | Intervention with VIPP-SD |
Primary outcome
Parental sensitivity: Erickson Scales of Parental Sensitivity (ESPS, Egeland, et al., 1990)
Time frame: Data will be collected at pretest, posttest (14 weeks) .
Parental sensitivity will be assessed using the the revised Erickson 7-point rating scales for Supportive Presence (from 1 = parent completely fails to be supportive to the child to 7 = parent skilfully provides support throughout the session) and Intrusiveness (from 1 = parent allows the child sufficient time to explore and to attempt to solve tools on her/his own to 7 = parent is highly intrusive; her agenda clearly has precedence over the child's wishes; Egeland et al., 1990). Supportive presence is defined as the consistent emotional, physical, and psychological availability of a mother, characterized by both verbal expressions and nonverbal behaviors. High sensitivity is associated with positive developmental outcomes in children, including secure attachment and better emotional regulation. Intrusiveness reflects the extent to which a parent disregards or interferes with the child's autonomy, wishes, interests, or behaviors.
5 secondary outcomes
Strengths & Difficulties Questionnaire" (SDQ Portuguese version Fleitlich et al., 2004)
Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Depression, Anxiety, and Stress Scale - 21 (DASS-21)
Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
AQOL-8D (Richardson & Lezzi, 2014)
Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Resource Use Characterization Questionnaire.
Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
Child Rearing Practices Report-Questionnaire (CRPR-Q)
Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).
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 5 Jan 2026.
- Derived from this study: PubMed 41163103Verissimo M, Guedes M, Fernandes M, Fernandes C, Santos C, Diniz E, Oliveira P, Negrao M, Sampaio F, Bakermans-Kranenburg M. Promoting socioemotional development in early childhood: implementation and evaluation of the VIPP-SD parenting intervention in Portugal. BMC Psychol. 2025 Oct 29;13(1):1190. doi: 10.1186/s40359-025-03431-3.
- Individual participant dataSharing planned: No. Intellectual Property Data (IPD) might not be shared due to concerns about confidentiality and legal restrictions. Sharing it could risk exposing proprietary or sensitive information, including details that may affect entire family's privacy.
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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.
Manuela Verissimo, PhD principal investigator
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPP-SD in people with Parent-Child Relations, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida 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?
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 5 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 xxxxx Investigator, PhD (xxxxxxx, mveriss@ispa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental sensitivity: Erickson Scales of Parental Sensitivity (ESPS, Egeland, et al., 1990) (time frame: Data will be collected at pretest, posttest (14 weeks) .). 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 NCT07153198, 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 5 Jan 2026.