Behavior ProblemH2M1NCT03004781
Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices (H2M1)
A study testing Parenting program in people with Behavior Problem, run by Université Catholique de Louvain.
Trial summary
This research compared the efficacy of two parenting interventions that vary according to the number and the nature of variables in reducing preschoolers' externalizing behavior (EB). Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Behavior Problem
- What is being tested?
- Parenting program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Oct 2015
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children in the clinical or borderline range of the EB scale (cut-off = 21 or higher) of the Child Behavior Checklist preschool form (Achenbach \& Rescorla, 2000a)
- three to six years old and still in kindergarten at the beginning of the intervention
Who cannot join
- children with intellectual disabilities (average IQ < 5.5)
- highly gifted children (average IQ >14.5)
About this study
Official title: Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices to Reduce Externalizing Behavior in Preschoolers
This research compared the efficacy of two parenting interventions that vary according to the number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The goal was to identify which parenting intervention format (one-variable versus two-variable) caused higher behavioral adjustment in children.
Read the detailed description
The first format was a one-variable intervention manipulating parental self-efficacy beliefs. The second format was a two-variable intervention manipulating both parents' self-efficacy beliefs and emotion coaching practices. The two interventions shared exactly the same design, consisting of eight parent group sessions. Effect on children's EB and observed behaviors were evaluated through a multi-method assessment at three points (pre-test, post-test and follow-up).
- Conditions
- Behavior Problem
- Being tested
- Parenting program
- Keywords
- parenting intervention, externalizing behavior, emotion coaching practices, self-efficacy beliefs
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Waiting-list | No intervention | 8-week period without intervention, N=45 |
| self-efficacy | Experimental | 8-week group-based parenting program on self-efficacy beliefs, N=19 Receives: Behavioral: Parenting program |
| self-efficacy/emotion coaching | Experimental | 8-week group-based parenting program on self-efficacy beliefs and emotion coaching practice, N=26 Receives: Behavioral: Parenting program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child behavior
parent reports of child behavior and standardized observation of parent-child interaction
Measured: 0 week, 8 weeks, 24 weeks
Secondary outcomes (2)
Change in parental self-efficacy beliefs
parent questionnaire
Measured: 0 week, 8 weeks, 24 weeks
Change in parenting behavior
standardized observation of parent-child interaction
Measured: 0 week, 8 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Roskam, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004781
- Sponsor's protocol ID
- UCLouvain_H2M1
- Acronym
- H2M1
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices to Reduce Externalizing Behavior in Preschoolers
- ClinicalTrials.gov ID
- NCT03004781
- Acronym / sponsor ID
- H2M1 / UCLouvain_H2M1
- Conditions
- Behavior Problem
- Keywords
- parenting intervention, externalizing behavior, emotion coaching practices, self-efficacy beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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 research compared the efficacy of two parenting interventions that vary according to the number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The goal was to identify which parenting intervention format (one-variable versus two-variable) caused higher behavioral adjustment in children.
Detailed description
The first format was a one-variable intervention manipulating parental self-efficacy beliefs. The second format was a two-variable intervention manipulating both parents' self-efficacy beliefs and emotion coaching practices. The two interventions shared exactly the same design, consisting of eight parent group sessions. Effect on children's EB and observed behaviors were evaluated through a multi-method assessment at three points (pre-test, post-test and follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waiting-list | No intervention | –8-week period without intervention, N=45 |
| self-efficacy | Experimental | Behavioral: Parenting program8-week group-based parenting program on self-efficacy beliefs, N=19 |
| self-efficacy/emotion coaching | Experimental | Behavioral: Parenting program8-week group-based parenting program on self-efficacy beliefs and emotion coaching practice, N=26 |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children in the clinical or borderline range of the EB scale (cut-off = 21 or higher) of the Child Behavior Checklist preschool form (Achenbach \& Rescorla, 2000a)
- three to six years old and still in kindergarten at the beginning of the intervention
Key exclusion criteria (2 listed)
- children with intellectual disabilities (average IQ < 5.5)
- highly gifted children (average IQ >14.5)
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 |
|---|---|---|
| Parenting program | Behavioural | self-efficacy, self-efficacy/emotion coaching |
Primary outcome
Change in child behavior
Time frame: 0 week, 8 weeks, 24 weeks
parent reports of child behavior and standardized observation of parent-child interaction
2 secondary outcomes
Change in parental self-efficacy beliefs
Time frame: 0 week, 8 weeks, 24 weeks
Change in parenting behavior
Time frame: 0 week, 8 weeks, 24 weeks
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 29 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Behavior Problem
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting program in people with Behavior Problem, run by Université Catholique de Louvain.
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 2 inclusion and 2 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 child behavior (time frame: 0 week, 8 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2016.