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

NCT02120430 | Completed Phase 3 DMC

• 1 other identifier: RC 60/07
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Knowledge, Attitudes, Practice

Keywords

Early childhood; Audiovisual materials; Parent-child interaction; Parenting programs; Timing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Feelings elicited

  15 days after being exposed to the intervention

Study Arms (2)

Early administration of the video

ACTIVE COMPARATOR

Video delivered at one month of child's life

Other: Video

Late administration of the video

EXPERIMENTAL

Video delivered at seven months of child's life

Other: Video

Interventions

Video OTHER

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.

Early administration of the video; Late administration of the video

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Related Publications (1)

• 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.

  PMID: 25193490 DERIVED

MeSH Terms

Conditions

Behavior

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Giorgio Tamburlini, MD, PhD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

IT (1)