Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)
NCT04656483 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2021-04-06
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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