Childhood Behavior ProblemsNCT05626244
Being a Parent: Evaluation of a Parenting Intervention for Childhood Behavioral Problems
A study testing Being a Parent in people with Childhood Behavior Problems and Positive Parenting Skills, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Behavior Problems, Positive Parenting Skills, Parental Concerns
- What is being tested?
- Being a Parent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2022to 9 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary caregivers who identify difficulties managing the behavior of a child between the ages of 2 and 11 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Childhood Behavior Problems, Positive Parenting Skills, Parental Concerns, Parents' Sense of Competence
- Being tested
- Being a Parent
- Keywords
- Parenting Interventions, Childhood, Behavior Problems, Positve Parenting
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Being a ParentBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will be receiving the parenting intervention (name of the intervention: Being a Parent). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 11 months
Secondary outcomes (3)
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).
Measured: Through study completion, up to 11 months
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.
Measured: 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)
Analyzes dysfunctional parenting practices.
Measured: Through study completion, up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Dec 2022
- Primary completion9 Dec 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Behavior ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial will have two arms, namely the intervention group and the waitlist control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Cecília Zino, King's College London
- Responsible party
- Principal investigator, Laura Maciel, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Investigators
- Laura Maciel, Ph.D. student, Principal investigator, Ispa - Instituto Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626244
- Sponsor's protocol ID
- EPEC_PT_2020
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40239337
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ser Pai & Ser Mãe: Avaliação de Uma intervenção Parental Para crianças Com Problemas
- ClinicalTrials.gov ID
- NCT05626244
- Acronym / sponsor ID
- EPEC_PT_2020
- Conditions
- Childhood Behavior Problems, Positive Parenting Skills, Parental Concerns, Parents' Sense of Competence
- Keywords
- Parenting Interventions, Childhood, Behavior Problems, Positve Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da VidaUniversity, hospital or other
- Collaborators
- Fundação Cecília Zino, King's College London
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled trial will have two arms, namely the intervention group and the waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Being a ParentThe intervention group will be receiving the parenting intervention (name of the intervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary caregivers who identify difficulties managing the behavior of a child between the ages of 2 and 11 years old.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Being a ParentBeing 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). | Behavioural | Intervention Group |
Primary outcome
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.
3 secondary outcomes
Change in the Parental Concerns Scale (Castro, 2012)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 40239337Maciel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Maciel, Ph.D. student principal investigator
Ispa - Instituto Universitário
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Being a Parent in people with Childhood Behavior Problems and Positive Parenting Skills, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.