NCT05626244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

November 15, 2022

Last Update Submit

December 9, 2023

Conditions

Keywords

Parenting InterventionsChildhoodBehavior ProblemsPositve Parenting

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, up to 11 months

Secondary Outcomes (3)

  • Change in the Parental Concerns Scale (Castro, 2012)

    Through study completion, up to 11 months

  • Change in the Parental Sense of Competence (PSOC; Johnston & Mash, 1989; portuguese version: Nunes et al., 2014)

    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)

    Through study completion, up to 11 months

Other Outcomes (1)

  • Research Qualitative Interview

    Through study completion, up to 11 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Being a Parent

Waitlist Control Group

NO INTERVENTION

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.

Interventions

Being a ParentBEHAVIORAL

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).

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary caregivers who identify difficulties managing the behavior of a child between the ages of 2 and 11 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ispa - Instituto Universitário

Lisbon, 1100-304, Portugal

Location

Related Publications (1)

  • Maciel L, Basto-Pereira M, Day C. Reducing childhood externalizing behavior: A feasibility RCT of the being a Parent program. Behav Res Ther. 2025 Jun;189:104737. doi: 10.1016/j.brat.2025.104737. Epub 2025 Apr 1.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Laura Maciel, Ph.D. student

    Ispa - Instituto Universitário

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This randomized controlled trial will have two arms, namely the intervention group and the waitlist control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Student

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

December 1, 2022

Primary Completion

December 9, 2023

Study Completion

December 9, 2023

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations