ParentingNCT07106775
Evaluation of the Family Intervention Program (PIF)
A study testing Family Intervention Program (PIF) in people with Parenting and Children/Adolescent Adjustment, run by University of Seville at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parenting, Children/Adolescent Adjustment, Family Functioning
- What is being tested?
- Family Intervention Program (PIF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2025to May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consejería de Inclusión Social, Juventud, Familias E Igualdad
Santander, Cantabria, 39004
José Ángel Rodríguez, 0034942207756, rodriguez_ja@cantabria.es
About this study
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.
Read the detailed description
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).
- Being tested
- Family Intervention Program (PIF)
- Keywords
- Positive parenting, Parenting competences, Program evaluation, Family functioning, Parenting practices, Effectiveness, Home program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Intervention Program (PIF)Behavioural
Home psychoeducational intervention in an individual format driven by a practitioner where caregivers learn parenting competences and children learn autonomy and emotional regulation skills
| Study group | Role | What they receive |
|---|---|---|
| Families receiving intervention | Experimental | Families who are participating in the home program Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family functioning
SCORE rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
This ad hoc instrument rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.
Measured: Before the intervention
Perceived change after 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.
Measured: 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
Client Satisfaction Questionnaire (CSQ-8), rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.
Measured: Every six months from the start of the intervention until the family achieves the proposed objectives (with a maximum intervention period of two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Jan 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Gobierno de Cantabria, Loyola University, University of Jaen
- Responsible party
- Principal investigator, Victoria Hidalgo García, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106775
- Sponsor's protocol ID
- PRJ202304792
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The project is framed in an agreement with the Govern of Cantabria and the researchers have no authorization for sharing individual participant data.
Publications
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
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.
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.
PubMed 10245370Diener 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.
PubMed 16367493Zabriskie, 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
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
European Kidscreen Groupe (2006). The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents. Pabst Science Publ.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Family Intervention Program (PIF)
- ClinicalTrials.gov ID
- NCT07106775
- Acronym / sponsor ID
- PRJ202304792
- Keywords
- Positive parenting, Parenting competences, Program evaluation, Family functioning, Parenting practices, Effectiveness, Home program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Gobierno de Cantabria, Loyola University, University of Jaen
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Aug 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 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Families receiving intervention | Experimental | Behavioral: Family Intervention Program (PIF)Families who are participating in the home program |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Family Intervention Program (PIF)Home psychoeducational intervention in an individual format driven by a practitioner where caregivers learn parenting competences and children learn autonomy and emotional regulation skills | Behavioural | Families receiving intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Expectations about the intervention
Time frame: Before the intervention
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)
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)
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 14 Aug 2025.
- BackgroundUgarriza 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
- BackgroundBar-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: PubMed 10245370Larsen 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.
- Background: PubMed 16367493Diener 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.
- BackgroundZabriskie, 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
- BackgroundStratton, 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
- BackgroundEuropean Kidscreen Groupe (2006). The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents. Pabst Science Publ.
- Report on the actions carried out for the advice and evaluation of the actions of the education and family intervention programs and services of the public social services of CantabriaLink provided by the sponsor.
- Family Intervention Program (PIF): Technical manual for its implementation and evaluationLink provided by the sponsor.
- Individual participant dataSharing planned: No. The project is framed in an agreement with the Govern of Cantabria and the researchers have no authorization for sharing individual participant data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Intervention Program (PIF) in people with Parenting and Children/Adolescent Adjustment, run by University of Seville at 1 site in Spain.
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 2 inclusion and 3 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 14 Aug 2025. 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 Spain. 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 Victoria Hidalgo García (0034954554332, victoria@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 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 NCT07106775, which also lists 7 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 14 Aug 2025.