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

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: Video

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• None

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early administration of the video; Video delivered at one month of child's life	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.
Experimental: Late administration of the video; Video delivered at seven months of child's life	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Giorgio Tamburlini, MD, PhD, IRCCS Burlo Garofolo, Trieste, Italy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: April 18, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Estimate): April 22, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Early childhood; Timing; Parent-child interaction; Audiovisual materials; Parenting programs
• Other Study ID Numbers: RC 60/07