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

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lisboa, Portugal, 1100-304
        • Ispa - Instituto Universitário

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Intervention Group
The intervention group will be receiving the parenting intervention (name of the intervention: Being a Parent).
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Through study completion, up to 11 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Parental Concerns Scale (Castro, 2012)
Time Frame: Through study completion, up to 11 months
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).
Through study completion, up to 11 months
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
Measures parental sense of competence as perceived by parents, by examining two dimensions, namely Efficacy and Satisfaction.
Through study completion, up to 11 months
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
Analyzes dysfunctional parenting practices.
Through study completion, up to 11 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research Qualitative Interview
Time Frame: Through study completion, up to 11 months
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
Through study completion, up to 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laura Maciel, Ph.D. student, Ispa - Instituto Universitário

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 9, 2023

Study Completion (Actual)

December 9, 2023

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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