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RecruitingNCT07153198SAF-ParentsUpdated Jan 5, 2026

Promoting Socioemotional Development in Early Childhood: Implementation and Evaluation of the VIPP-SD Parenting Intervention in Portugal

An interventional study of VIPP-SD in Parent-Child Relations, sponsored by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida. Recruiting at 1 site in Portugal. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study 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). 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

  1. 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.
  2. 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.
  3. 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.
  4. 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
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Conditions studied

  • Parent-Child Relations

Keywords

  • sensitivity
  • attachment
  • behavioral problems
  • economic advantages
03

In context

Hypersensitivity

1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.

This study's planned enrollment of 120 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida is the lead sponsor of 11 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

-

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Intervention with VIPP-SD

    Intervention group:

    Other: VIPP-SD

  • No intervention
    Control Group: No intervention

    No Intervention

Interventions

  • OtherVIPP-SD

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Data will be collected at pretest, posttest (14 weeks) .

Secondary outcomes

  1. 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.

    Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).

  2. 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.

    Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).

  3. 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.

    Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).

  4. 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.

    Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).

  5. 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

    Time frame: Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).

07

Study locations

1 of 1 sites recruiting
  • Manuela Verissimo
    Lisbon, Lisbon District 2795-233, Portugal
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: 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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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 150 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 11 months is below that.

Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2025
First posted
Sep 3, 2025
StartActual
Jan 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2027
Last update
Jan 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07153198
Lead sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Responsible party
Maria Manuela Pedro Veríssimo (Professor, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida) — Principal investigator
First posted
Sep 3, 2025
Start date
Jan 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 5, 2026

Study contacts

xxxxx Investigator, PhD
Contact
mveriss@ispa.pt
xxxxxxx
Manuela Verissimo, PhD
principal investigator · ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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