Promoting Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times

Health Knowledge, Attitudes, Practice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120430
• Other study ID #: RC 60/07
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2014
• Last updated: April 18, 2014
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: April 2014
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Other:
• Video
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.

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 days after being exposed to the intervention	No
Secondary	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	15 days after being exposed to the intervention	No