- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06285552
Evaluation of the Comprehensive Family Support Program (PAIF)
The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).
We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.
We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A quasi-experimental design will be followed, with three evaluation moments (pretest, posttest and follow-up) and with a non-randomized comparison group.
The positive parenting programs will be advertised by social media, schools and high schools. The participants will be parental figures interested in joining these programs.
The participants will answer a series of questionnaires by an app, where they will give information related to sociodemographic data and parenting competencies. The app will not allow the participants to leave any question with no answer or with an incorrect answer.
To analyze the data, we will use the softwares Mplus and Statistical Package for the Social Sciences (SPSS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cantabria
-
Santander, Cantabria, Spain, 39004
- Consejería de Inclusión Social, Juventud, Familias E Igualdad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being caregiver of at least one child under 18 years of age
- The child to be in the developmental stage appropriate for the corresponding arm
- If participating in a targeted program, meet the requirements: (1) be a father; (2) presenting bad health habits in the family according the evaluation of the pediatrician
- Motivated to improve parenting competences
Exclusion Criteria:
- Not having sufficient command of the Spanish language to be able to communicate
- Experience family crisis that prevent for participating in a group intervention
- Experience mental health issue that prevent for participating in a group intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parenting newborn
Program aimed at community families with children enrolled in Early Childhood Care Centers (from 0 to 2 years old).
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
|
Experimental: Parenting Toddlers
Program aimed at community families with children from 2 to 5 years old.
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
|
Experimental: Parenting Children
Program aimed at community families with children from 6 to 12 years old.
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
|
Experimental: Parenting Adolescents
Program aimed at community families with children from 12 to 18 years old.
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
|
Experimental: Active and Health Families
Program aimed at targeted families due identified needs for healthy lifestyle habits
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
|
Experimental: Functional diversity Parenting
Program aimed at targeted families whose children and/or adolescents exhibit functional diversity characteristics
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
|
No Intervention: Control
Families that are not participating in any program as they live in a comparable area where any of the intervention is offered
|
|
|
Experimental: Parenting as as Father
Program aimed at fathers from the community population
|
Psychoeducational intervention in a group format driven by a practitioner with 6 to 12 sessions where caregivers learn parenting competences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perception of the parental role
Time Frame: Pretest, immediately posttest and 6 month follow-up
|
Me as a Parent Scale (MaaP), rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.
|
Pretest, immediately posttest and 6 month follow-up
|
|
Parenting practices (Authoritative parenting style: Warmth and Support, Reasoning/Induction, Democratic Participation)
Time Frame: Pretest, immediately posttest and 6 month follow-up
|
Parenting Styles and Dimensions Questionnaire - Short version (PSDQ-Short version), rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.
|
Pretest, immediately posttest and 6 month follow-up
|
|
Parenting practices (Overreactivity and Laxness)
Time Frame: Pretest, immediately posttest and 6 month follow-up
|
Parenting Scale - Short version (PS), rated on a 7-point Likert-type scale ranging from 1 to 7. Higher scores mean a worse outcome.
|
Pretest, immediately posttest and 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with the intervention
Time Frame: Immediately Posttest
|
Client Satisfaction Questionnaire (CSQ-4), rated on a 4-point Likert-type scale ranging from 1 to 4. Higher scores mean a better outcome.
|
Immediately Posttest
|
|
Children adjustment
Time Frame: Pretest, immediately posttest and 6 month follow-up
|
Kidscreen-10, rated on a 5-point Likert-type scale ranging from 1 to 5. Higher scores mean a better outcome.
|
Pretest, immediately posttest and 6 month follow-up
|
|
Social support
Time Frame: Pretest, immediately posttest and 6 month follow-up
|
Ad hoc questionnaire, with 3 items rated on a 5-point Likert-type scale ranging from 1 = Nothing to 4 = A lot ("I feel supported as a father/mother).
Higher scores mean a better outcome.
|
Pretest, immediately posttest and 6 month follow-up
|
|
Satisfaction with Family Life
Time Frame: Pretest, posttest and follow-up
|
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.
|
Pretest, posttest and follow-up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Hamilton, V., Matthews, J. & Crawford, S. (2015). Development and preliminary validation of a parenting self-regulation scale: "Me as a Parent". Journal of Child & Family Studies. 24(10), 2853-2864. https://doi.org/10.1007/s10826-014-0089-z
- Robinson, C. C., Mandleco, B., Olsen, S. F., & Hart, C. H. (1995). Authoritative, Authoritarian, and Permissive Parenting Practices: Development of a New Measure. Psychological Reports, 77(3), 819-830. https://doi.org/10.2466/pr0.1995.77.3.819
- Reitman D, Currier RO, Hupp SD, Rhode PC, Murphy MA, O'Callaghan PM. Psychometric characteristics of the Parenting Scale in a head start population. J Clin Child Psychol. 2001 Dec;30(4):514-24. doi: 10.1207/S15374424JCCP3004_08.
- Ramon B. Zabriskie & Peter J. Ward (2013) Satisfaction With Family Life Scale, Marriage & Family Review, 49:5, 446-463, DOI: 10.1080/01494929.2013.768321
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4792/0842
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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