NCT07106775

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

July 21, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

Positive parentingParenting competencesProgram evaluationFamily functioningParenting practicesEffectivenessHome program

Outcome Measures

Primary Outcomes (9)

  • Family functioning

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

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

  • Children's quality of life

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

    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

    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.

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

  • Emotional intelligence

    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.

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

  • Indicators of social integration of the family

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

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

  • Children adjustment

    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.

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

  • School adjustment indicators

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

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

  • Parental Competencies

    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.

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

  • Autonomy and life skills

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

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

Secondary Outcomes (3)

  • Expectations about the intervention

    Before the intervention

  • Perceived change after the intervention

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

  • Satisfaction with the intervention

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

Study Arms (2)

Families receiving intervention

EXPERIMENTAL

Families who are participating in the home program

Behavioral: Family Intervention Program (PIF)

Control group

NO INTERVENTION

Families who are not participating in the program and live in a comparable area where any of the intervention is offered

Interventions

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

Families receiving intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consejería de Inclusión Social, Juventud, Familias E Igualdad

Santander, Cantabria, 39004, Spain

RECRUITING

Related Publications (7)

  • Ugarriza Chávez, N., y Pajares Del Águila, L. (2005). La evaluación de la inteligencia emocional a través del inventario de BarOn ICE: NA, en una muestra de niños y adolescentes. Persona, 8, 11-58. https://www.redalyc.org/articulo.oa?id=147112816001

    BACKGROUND
  • Bar-On, R. (1997a). Development of the Baron EQ-I: A measure of emotional and social intelligence. 105th Annual Convention of the American Psychological Association in Chicago.

    BACKGROUND
  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PMID: 10245370BACKGROUND
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PMID: 16367493BACKGROUND
  • Zabriskie, R. y McCormick, B. (2003). Parent and child perspectives of family leisure involvement and satisfaction with family life. Journal of Leisure Research, 35, 163-189. doi: 10.1080/00222216.2003.11949989

    BACKGROUND
  • Stratton, P., Bland, J., Janes, E. y Lask, J. (2010). Developing a practicable outcome measure for systemic family therapy: The SCORE. Journal of Family Therapy, 32, 232-258. doi: 10.1111/j.1467-6427.2010.00507.x

    BACKGROUND
  • European Kidscreen Groupe (2006). The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents. Pabst Science Publ.

    BACKGROUND

Related Links

Central Study Contacts

Victoria Hidalgo García

CONTACT

Javier Pérez Padilla

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The participants will be assigned to the manualized program according to the inclusion criteria. The comparison group will be composed of families in areas where the intervention is not available but with similar sociodemographic characteristics.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 6, 2025

Study Start

January 15, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The project is framed in an agreement with the Govern of Cantabria and the researchers have no authorization for sharing individual participant data.

Locations