Health Knowledge, Attitudes, PracticePhase 3NCT02120430
Promoting Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times
A Phase 3 study testing Video in people with Health Knowledge, Attitudes, Practice, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
There is an increasing need for parenting programs aimed at promoting parent-child interaction. A variety of interventions have been proposed. The use of audiovisual materials for parents has been shown to be effective but limited information is available on the optimal timing for its use, particularly for new parents… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- first parenting experience
- local residence
- no major health or psychosocial problems in parents and in the newborn
- no delay in discharge from the maternity ward
- adequate knowledge of Italian
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Effective Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times. A Randomized Controlled Trial
There is an increasing need for parenting programs aimed at promoting parent-child interaction. A variety of interventions have been proposed. The use of audiovisual materials for parents has been shown to be effective but limited information is available on the optimal timing for its use, particularly for new parents during the first year of life of their children.
Based on the hypothesis that the effectiveness of information provided to first-time parents in modifying their knowledge, attitudes and intentions regarding rearing practices may depend on when the information is delivered, we designed an open randomized controlled trial to compare the effectiveness of administering a video at two different times, i.e. at one and seven months of age of the child.
The video addressed four specific activities related to early child development: reading aloud to the baby, early exposure to music, promotion of early socialization for parents and for children.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Video
- Keywords
- Early childhood, Audiovisual materials, Parent-child interaction, Parenting programs, Timing
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
The video was developed by a multidisciplinary team (psychologists, paediatricians, filmmaker). It was conceived as an aid to parenting in the first year of life, providing opportunities for parents to look at their own experiences. The video lasts 24 minutes and describes "the birth of a new relationship" between primary caregivers and their babies, in chronological order, starting from late pregnancy to the end of the first year. Caregiver-child interactions are shown from early contact after delivery to common care practices, with an emphasis on four specific activities, which are believed to improve child development and caregiver-child interaction: reading aloud to the baby, exposure to songs, rhymes and music, promotion of early socialization for parents and for children.
| Study group | Role | What they receive |
|---|---|---|
| Early administration of the video | Active comparator | Video delivered at one month of child's life Receives: Other: Video |
| Late administration of the video | Experimental | Video delivered at seven months of child's life Receives: Other: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental knowledge, attitudes and intentions
Closed-ended questions about the four specific activities examined (reading aloud, exposure to music, caregiver and child early socialization) collected through a researcher-administered structured questionnaire
Measured: 15 days after being exposed to the intervention
Secondary outcomes (1)
Feelings elicited
Closed-ended questions collected through a researcher-administered structured questionnaire. Eight categories of emotions were evaluated: happiness, sadness, fear, rage, guilt, sense of competence, lack of self-confidence, and sense of inadequacy
Measured: 15 days after being exposed to the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
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 Health Knowledge, Attitudes, PracticeStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Giorgio Tamburlini, MD, PhD, Study director, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120430
- Sponsor's protocol ID
- RC 60/07
- Status last verified
- Apr 2014
- First submitted
- 18 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roia A, Paviotti E, Ferluga V, Montico M, Monasta L, Ronfani L, Tamburlini G. Promoting effective child development practices in the first year of life: does timing make a difference? BMC Pediatr. 2014 Sep 5;14:222. doi: 10.1186/1471-2431-14-222.
PubMed 25193490
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Effective Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02120430
- Acronym / sponsor ID
- RC 60/07
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Early childhood, Audiovisual materials, Parent-child interaction, Parenting programs, Timing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Apr 2014 (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.
There is an increasing need for parenting programs aimed at promoting parent-child interaction. A variety of interventions have been proposed. The use of audiovisual materials for parents has been shown to be effective but limited information is available on the optimal timing for its use, particularly for new parents during the first year of life of their children.
Based on the hypothesis that the effectiveness of information provided to first-time parents in modifying their knowledge, attitudes and intentions regarding rearing practices may depend on when the information is delivered, we designed an open randomized controlled trial to compare the effectiveness of administering a video at two different times, i.e. at one and seven months of age of the child.
The video addressed four specific activities related to early child development: reading aloud to the baby, early exposure to music, promotion of early socialization for parents and for children.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early administration of the video | Active comparator | Other: VideoVideo delivered at one month of child's life |
| Late administration of the video | Experimental | Other: VideoVideo delivered at seven months of child's life |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- first parenting experience
- local residence
- no major health or psychosocial problems in parents and in the newborn
- no delay in discharge from the maternity ward
- adequate knowledge of Italian
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| VideoThe video was developed by a multidisciplinary team (psychologists, paediatricians, filmmaker). It was conceived as an aid to parenting in the first year of life, providing opportunities for parents to look at their own experiences. The video lasts 24 minutes and describes "the birth of a new relationship" between primary caregivers and their babies, in chronological order, starting from late pregnancy to the end of the first year. Caregiver-child interactions are shown from early contact after delivery to common care practices, with an emphasis on four specific activities, which are believed to improve child development and caregiver-child interaction: reading aloud to the baby, exposure to songs, rhymes and music, promotion of early socialization for parents and for children. | Other | Early administration of the video, Late administration of the video |
Primary outcome
Parental knowledge, attitudes and intentions
Time frame: 15 days after being exposed to the intervention
Closed-ended questions about the four specific activities examined (reading aloud, exposure to music, caregiver and child early socialization) collected through a researcher-administered structured questionnaire
1 secondary outcome
Feelings elicited
Time frame: 15 days after being exposed to the intervention
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 22 Apr 2014.
- Derived from this study: PubMed 25193490Roia A, Paviotti E, Ferluga V, Montico M, Monasta L, Ronfani L, Tamburlini G. Promoting effective child development practices in the first year of life: does timing make a difference? BMC Pediatr. 2014 Sep 5;14:222. doi: 10.1186/1471-2431-14-222.
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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.
Giorgio Tamburlini, MD, PhD study director
IRCCS Burlo Garofolo, Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Video in people with Health Knowledge, Attitudes, Practice, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 5 inclusion and 1 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 22 Apr 2014. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parental knowledge, attitudes and intentions (time frame: 15 days after being exposed to the intervention). 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 NCT02120430, 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 22 Apr 2014.