search
Back to results

Being a Parent: Evaluation of a Parenting Intervention for Childhood Behavioral Problems

Primary Purpose

Childhood Behavior Problems, Positive Parenting Skills, Parental Concerns

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Being a Parent
Sponsored by
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Behavior Problems focused on measuring Parenting Interventions, Childhood, Behavior Problems, Positve Parenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ispa - Instituto UniversitárioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Waitlist Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in the Child Behavior Checklist for Preschool and School Years (CBCL; Achenbach & Rescorla, 2001; Portuguese version: Achenbach et al., 2014)
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.

Secondary Outcome Measures

Change in the Parental Concerns Scale (Castro, 2012)
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).
Change in the Parental Sense of Competence (PSOC; Johnston & Mash, 1989; portuguese version: Nunes et al., 2014)
Measures parental sense of competence as perceived by parents, by examining two dimensions, namely Efficacy and Satisfaction.
Change in the Parental Styles and Dimensions Questionnaire (PSDQ; Robinson et al., 2001; portuguese version: Pedro et al., 2015)
Analyzes dysfunctional parenting practices.

Full Information

First Posted
November 15, 2022
Last Updated
December 12, 2022
Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Collaborators
Fundação Cecília Zino, King's College London
search

1. Study Identification

Unique Protocol Identification Number
NCT05626244
Brief Title
Being a Parent: Evaluation of a Parenting Intervention for Childhood Behavioral Problems
Official Title
Ser Pai & Ser Mãe: Avaliação de Uma intervenção Parental Para crianças Com Problemas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Collaborators
Fundação Cecília Zino, King's College London

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Behavior Problems, Positive Parenting Skills, Parental Concerns, Parents' Sense of Competence
Keywords
Parenting Interventions, Childhood, Behavior Problems, Positve Parenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This randomized controlled trial will have two arms, namely the intervention group and the waitlist control group.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will be receiving the parenting intervention (name of the intervention: Being a Parent).
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Being a Parent
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in the Child Behavior Checklist for Preschool and School Years (CBCL; Achenbach & Rescorla, 2001; Portuguese version: Achenbach et al., 2014)
Description
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.
Time Frame
Through study completion, up to 11 months
Secondary Outcome Measure Information:
Title
Change in the Parental Concerns Scale (Castro, 2012)
Description
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).
Time Frame
Through study completion, up to 11 months
Title
Change in the Parental Sense of Competence (PSOC; Johnston & Mash, 1989; portuguese version: Nunes et al., 2014)
Description
Measures parental sense of competence as perceived by parents, by examining two dimensions, namely Efficacy and Satisfaction.
Time Frame
Through study completion, up to 11 months
Title
Change in the Parental Styles and Dimensions Questionnaire (PSDQ; Robinson et al., 2001; portuguese version: Pedro et al., 2015)
Description
Analyzes dysfunctional parenting practices.
Time Frame
Through study completion, up to 11 months
Other Pre-specified Outcome Measures:
Title
Research Qualitative Interview
Description
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
Time Frame
Through study completion, up to 11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Maciel
Phone
+351966237584
Email
capacitarpaisecomunidades@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Maciel, Ph.D. student
Organizational Affiliation
Ispa - Instituto Universitário
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ispa - Instituto Universitário
City
Lisboa
ZIP/Postal Code
1100-304
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Maciel
Phone
+351966237584
Email
capacitarpaisecomunidades@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://serpaiesermae.com
Description
Projects' website

Learn more about this trial

Being a Parent: Evaluation of a Parenting Intervention for Childhood Behavioral Problems

We'll reach out to this number within 24 hrs