Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)
SPHERE
1 other identifier
interventional
168
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
January 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 6, 2021
April 1, 2021
2.5 years
November 30, 2020
April 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maternal sensitivity
The maternal sensitivity will be coded through the Global Rating Scales (Murray, Fiori-Cowley, Hooper, \& Cooper, 1996). The score will range from 1 (low) to 5 (high).
Immediate post-intervention (6 weeks after the intervention started)
Secondary Outcomes (3)
Infant emotional stress reactivity
Immediate post-intervention (6 weeks after the intervention started)
Maternal sensitivity
Follow-up (6 months adfter the intervention ended)
Infant emotional stress reactivity
Follow-up (6 months adfter the intervention ended)
Other Outcomes (8)
Maternal Stress
Immediate post-intervention (6 weeks after the intervention started)
Maternal Stress
Follow-up (6 months adfter the intervention ended)
Maternal depression
Immediate post-intervention (6 weeks after the intervention started)
- +5 more other outcomes
Study Arms (2)
Telemedicine Video Feedback Arm
EXPERIMENTALMother-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.
Psychoeducational booklet arm
ACTIVE COMPARATORMothers assigned to condition B will receive an informative booklet addressing the same themes discussed in the experimental intervention (i.e., responsiveness, physical stimulation, teaching, and parenting experience), but not tailored on their own infant or specific parenting challenges.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- infants' (corrected) age between 1 and 18 months;
- presence of developmental risk or diagnosis of ND as defined by standardized clinical criteria;
- parental age greater than 18 years;
- parental mastery of Italian language;
- parents living together with the infant.
You may not qualify if:
- Twins;
- Infant's life-threatening conditions;
- Maternal full-blown documented psychiatric disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mondino Foundation
Pavia, PV, 27100, Italy
Related Publications (1)
Grumi S, Borgatti R, Provenzi L. Supporting Parenting at Home-Empowering Rehabilitation through Engagement (SPHERE): study protocol for a randomised control trial. BMJ Open. 2021 Dec 14;11(12):e051817. doi: 10.1136/bmjopen-2021-051817.
PMID: 34907057DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Serena Grumi, PhD
IRCCS Mondino Foundation, Pavia, Italy
- STUDY CHAIR
Livio Provenzi, PhD
IRCCS Mondino Foundation, Pavia, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 7, 2020
Study Start
January 7, 2021
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
April 6, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share