- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05626244
Being a Parent: Evaluation of a Parenting Intervention for Childhood Behavioral Problems
Ser Pai & Ser Mãe: Avaliação de Uma intervenção Parental Para crianças Com Problemas
This randomized controlled trial aims to test the efficacy of an early parenting intervention for childhood behavior problems in the portuguese community. More specifically, this research intends to: 1) examine the effects of the parenting intervention in childhood behavior problems, positive parenting skills and parental concerns; 2) test participants' adherence, acceptability and dropout rates of the parenting intervention; and 3) qualitatively analyze the experience of parents' who received the intervention.
Researchers will compare an intervention group with a waitlist control group to see if there are any significant differences between these groups regarding childhood behavior problems and the aforementioned parenting dimensions.
Participants in both groups will be able to participate in the parenting intervention that has a duration of 9 weeks. Furthermore, they will be asked to fill in pre and post data.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lisboa, Portugal, 1100-304
- Ispa - Instituto Universitário
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary caregivers who identify difficulties managing the behavior of a child between the ages of 2 and 11 years old.
Exclusion Criteria:
- Primary caregivers of children with serious neurodevelopmental or cognitive disorders diagnosed;
- Primary caregivers of children institucionalized;
- Primary caregivers who do not comprehend, read or write in portuguese;
- Primary caregivers inability to commit to weekly sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
The intervention group will be receiving the parenting intervention (name of the intervention: Being a Parent).
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Being a Parent (BaP) is a group parenting intervention for parents of children (2-11 years old) with behavioral problems.
It consists of 2-hour sessions facilitated by psychologists for between 8-12 parents.
Based on attachment, family systems, and cognitive-behavioral theories, BaP successfully integrates knowledge acquisition, behavior change with adult learning and social support.
Each course session is highly interactive involving an engaging blend of small and large group discussion, role play, demonstrations, information sharing and reflection.
This enables parents to practice and use new skills to achieve specific goals (Day et al., 2020).
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No Intervention: Waitlist Control Group
The control group will be in a waitilist condition, in which they will not receive any intervention during the trial, but posteriorly will have the opportunity to receive the parenting intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the Child Behavior Checklist for Preschool and School Years (CBCL; Achenbach & Rescorla, 2001; Portuguese version: Achenbach et al., 2014)
Time Frame: Through study completion, up to 11 months
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Based on parents' reports, it assesses behaviors that have been present for the past six months in youth between the ages of 1.5 and 18 years old.
Each item is assessed using a 3-point Likert scale, ranging from Not True to Completely True.
Only the broadband Externalizing Domain and its subdimensions will be used, which assesses behavioral problems, and comprises 28 items for the Preschool Years and 71 for the School Years.
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Through study completion, up to 11 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the Parental Concerns Scale (Castro, 2012)
Time Frame: Through study completion, up to 11 months
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It is constituted by 21 items, divided into five concern dimensions, namely family and school problems; eating, sleep and physical complaints; preparation; fears; and negative behaviors.
Parents must answer using a 5-point Likert scale (Not concerned to Extremely concerned).
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Through study completion, up to 11 months
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Change in the Parental Sense of Competence (PSOC; Johnston & Mash, 1989; portuguese version: Nunes et al., 2014)
Time Frame: Through study completion, up to 11 months
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Measures parental sense of competence as perceived by parents, by examining two dimensions, namely Efficacy and Satisfaction.
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Through study completion, up to 11 months
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Change in the Parental Styles and Dimensions Questionnaire (PSDQ; Robinson et al., 2001; portuguese version: Pedro et al., 2015)
Time Frame: Through study completion, up to 11 months
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Analyzes dysfunctional parenting practices.
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Through study completion, up to 11 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Research Qualitative Interview
Time Frame: Through study completion, up to 11 months
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Qualitative interviews will be carried out with a selection of parents who received the parenting intervnetion in order to analyze they experience and overall satisfaction of the parenting intervention
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Through study completion, up to 11 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Laura Maciel, Ph.D. student, Ispa - Instituto Universitário
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPEC_PT_2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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