Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)

NCT04656483 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-04-06

No results posted yet for this study

Summary

Infants with Neurodevelopmental Disabilities (ND) show emotional, cognitive and socio-interactive dysregulation dramatically impacting on caregiving behavior. Early family-centered rehabilitation interventions are effective in promoting better infant outcomes and in optimizing healthcare systems economic return in the long-term. The Video Feedback intervention (VFI) is effective in promoting sensitive parenting and supporting infants' development. In the light of limited resources of the healthcare systems, technological advance in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. Consistently, the Supporting Parenting at Home: Empowering Rehabilitation through Engagement (SPHERE) project is a randomized controlled trial (RCT) aiming at assessing effectiveness and efficacy of an early family centered VFI parenting support delivered through videoconferencing on dyads with infants with ND.

Conditions

  • Neurodevelopmental Disorders

Interventions

OTHER

Telemedicine Video Feedback Intervention

Mother-child dyads will take part into a 6 video-conference sessions of Video Feedback (vVF). The vVF will be standardized according to previously published RCTs. Specifically, the 6 vVFI sessions will be organized in two subsequent phases: 4 sessions based on sharing the focus on different relational themes, and 2 sessions of interactive integration. In more specific terms, during the first set of 4 sessions the psychologist will review with mothers' segments of the videotapes obtained during the baseline assessment and will focus on four different relational themes: responsiveness, physical stimulation, teaching, and parenting experience. During the interactive integration session, the insights developed from the first 4 videoconferences will be applied to the real-time interaction between the parent and his/her infant under the guidance of the psychologist.

OTHER

Psychoeducational Booklet Intervention

Mothers of this condition will receive an informative booklet addressing the same themes included in the experimental intervention (responsiveness, physical stimulation, teaching, and parenting experience), but not tailored on their own infant status.

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Serena Grumi, PhD · IRCCS Mondino Foundation, Pavia, Italy

  • Livio Provenzi, PhD · IRCCS Mondino Foundation, Pavia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04656483 on ClinicalTrials.gov