Clinical trial NCT04656483: Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)
Official title: Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurodevelopmental Disorders
Keywords: early family-centered intervention
telemedicine
video feedback
parenting
telerehabilitation
disability
psychomotor delay
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 168
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Infants with Neurodevelopmental Disabilities (ND) show emotional, cognitive and socio-interactive dysregulation dramatically impacting on caregiving behavior. Parents may report critical emotional burden with heightened risk for chronic levels of distress, depression and anxiety. This constitutes a crucial point considering that parenting represents the first preventive factors for infants' development also in the presence of ND conditions. Thus, it is not surprising that early rehabilitation interventions that focus on the parent-infant dyad have been found to be the most effective in recent meta-analytic study and to be the most rewarding for healthcare systems in terms of economic return in the long-term. Specifically, the VFI constitutes an early family-centered intervention that proved to be effective in promoting sensitive parenting and supporting infants' behavioral and socio-emotional development. The use of VFI intervention has been also documented to be beneficial in dyads of children with neurodevelopmental disability reducing child's disruptive and emotionally negative behaviors; promoting maternal sensitivity, increasing self- efficacy and reducing parenting stress. It should be highlighted that delivering VFI in hospital or home-based context should be highly demanding for the healthcare systems due to high cost and disparities in access to the service for families in remote areas. As such, delivering VFI through telemedicine approaches (e.g., videoconferencing) appears to hold promises of promoting a reduction in inequality of care, greater access to early family-centered support and a more effective and efficient promotion of health outcomes for infants with ND. We still do not know how a VFI support for parents of infants with ND may end up in being effective and efficient in terms of promoting infants' development and parental health. Consistently, the Supporting Parenting at Home: Empowering Rehabilitation through Engagement (SPHERE) project is a randomized controlled trial (RCT) aiming at assessing effectiveness of an early family centered VFI parenting support delivered through videoconferencing on dyads with infants with ND.

The SPHERE RCT will include two arms (see arm description) and three assessment phases: T0, baseline; T1, immediate post-intervention; T2, follow-up (6 months after the intervention). For both arms, standardized assessment sessions will include video-recording of mother-infant interaction and maternal self-report scales (depression \[Beck Depression Inventory, BDI; Beck et al., 1961\]; anxiety \[State-Trait Anxiety Inventory, STAI-Y, Spielberg, 1983\] parenting stress, \[Parenting Stress Index, PSI; Abidin, 1983\] and infants' temperament \[Infant Behavior Questionnaire Revised, IBQ-R, Gartstein et al., 2003\]).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Twins;
* Infant's life-threatening conditions;
* Maternal full-blown documented psychiatric disorders.

Primary outcomes:
measure: Maternal sensitivity
timeFrame: Immediate post-intervention (6 weeks after the intervention started)
Secondary outcomes:
measure: Infant emotional stress reactivity
timeFrame: Immediate post-intervention (6 weeks after the intervention started)
measure: Maternal sensitivity
timeFrame: Follow-up (6 months adfter the intervention ended)
measure: Infant emotional stress reactivity
timeFrame: Follow-up (6 months adfter the intervention ended)
Other outcomes:
measure: Maternal Stress
timeFrame: Immediate post-intervention (6 weeks after the intervention started)
measure: Maternal Stress
timeFrame: Follow-up (6 months adfter the intervention ended)
measure: Maternal depression
timeFrame: Immediate post-intervention (6 weeks after the intervention started)
measure: Maternal depression
timeFrame: Follow-up (6 months adfter the intervention ended)
measure: Maternal anxiety
timeFrame: Immediate post-intervention (6 weeks after the intervention started)
measure: Maternal anxiety
timeFrame: Follow-up (6 months adfter the intervention ended)
measure: Infant temperament regulation
timeFrame: Immediate post-intervention (6 weeks after the intervention started)
measure: Infant temperament regulation
timeFrame: Follow-up (6 months adfter the intervention ended)
Locations:
city: Pavia
country: Italy
facility: Mondino Foundation
state: PV
Study officials:
affiliation: IRCCS Mondino Foundation, Pavia, Italy
name: Serena Grumi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Mondino Foundation, Pavia, Italy
name: Livio Provenzi, PhD
role: STUDY_CHAIR
References:
citation: 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.