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NCT Number: NCT07106775

Evaluation of the Family Intervention Program (PIF)

The goal of this study is to evaluate the effectiveness of home positive parenting programs targeted to families at psychosocial risk carried out in Cantabria (Spain).

The investigators will collect information before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years). Besides, the investigators will compare these results with information from other families that are not taking part in the program. Depending on the case, the practitioners in charge of the intervention, the main caregivers of the participating families and/or the adolescents will provide the information for the study.

The investigators expect that families participating in the programs will improve their parenting competencies, their family dynamics, and the life quality of their children.

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Key information

Conditions

Parenting Children/Adolescent Adjustment Family Functioning

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consejería de Inclusión Social, Juventud, Familias E Igualdad

Santander, Cantabria, 39004, Spain

Location status: Recruiting

Location contact

José Ángel Rodríguez

CONTACT

[email protected]

0034942207756

About this study

A quasi-experimental design will be followed, with at least three evaluation moments and with a non-randomized comparison group.

Families will be referred to the PIF from social services. The participants will answer a series of questionnaires and scales, where they will give information related to sociodemographic data, parenting competencies, family functioning and children/adolescent adjustment. The information will be digitized through a computer application to which only the professional intervening with the family will have access. The app will not allow the participants to leave any question with no answer or with an incorrect answer.

To analyze the data, the investigators will use the softwares Mplus and Statistical Package for the Social Sciences (SPSS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a psychosocial at-risk family with at least one child under 18 years of age
  • Living in the territory that corresponds to that social services center

Exclusion criteria

  • Experience family crisis that prevent for participating in the home intervention
  • Experience mental health issue that prevent for participating in the home intervention
  • High level of psychosolcial risk

Treatment and study plan

Family Intervention Program (PIF)

Behavioral

Home psychoeducational intervention in an individual format driven by a practitioner where caregivers learn parenting competences and children learn autonomy and emotional regulation skills

Primary outcomes

  1. Family functioning

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    SCORE rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.

  2. Children's quality of life

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    KIDSCREEN-10 rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.

  3. Satisfaction with Family Life

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    Satisfaction with Family Life Scale (SWFLS), rated on a 7-point Likert-type scale ranging from 1 to 7. Higher scores mean a better outcome.

  4. Emotional intelligence

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    The Emotional Quotient Inventory: Youth Version (EQ-i:YV) rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.

  5. Indicators of social integration of the family

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    This ad hoc instrument rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.

  6. Children adjustment

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    The Strengths and Difficulties Questionnaire (SDQ) rated on a 3-point Likert-type scale ranging from 0 to 2. Higher scores mean a better outcome.

  7. School adjustment indicators

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    This ad hoc instrument rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.

  8. Parental Competencies

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    The Parenting Competencies Assessment Interview (ECP - 12) rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.

  9. Autonomy and life skills

    Time frame: Before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years)

    The Life Skills Inventory (LSI) rated on a 2-point Likert-type scale ranging from 0 to 1. Higher scores mean a better outcome.

Secondary outcomes

  1. Expectations about the intervention

    Time frame: Before the intervention

    This ad hoc instrument rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.

  2. Perceived change after the intervention

    Time frame: Every six months from the start of the intervention until the family achieves the proposed objectives (with a maximum intervention period of two years)

    This ad hoc instrument rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.

  3. Satisfaction with the intervention

    Time frame: Every six months from the start of the intervention until the family achieves the proposed objectives (with a maximum intervention period of two years)

    Client Satisfaction Questionnaire (CSQ-8), rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Pérez Padilla

CONTACT

[email protected]

0034601373627

Victoria Hidalgo García

CONTACT

[email protected]

0034954554332

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Gobierno de Cantabria
  • Loyola University
  • University of Jaen

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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