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

Neurodevelopmental Disorders Clinical Trial

— SPHERE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656483
• Other study ID #: SPHERE
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2021
• Source: IRCCS National Neurological Institute "C. Mondino" Foundation
• Contact: Livio Provenzi, PhD
• Phone: 0382/380287
• Email: livio.provenzi[@]mondino.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Mondino Foundation	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Stress	Measured through the self-report scale Parenting Stress Index (PSI; Abidin, 1983). PSI total score ranges from 36 (low) to 180 (high).	Immediate post-intervention (6 weeks after the intervention started)
Other	Maternal Stress	Measured through the self-report scale Parenting Stress Index (PSI; Abidin, 1983). PSI total score ranges from 36 (low) to 180 (high).	Follow-up (6 months adfter the intervention ended)
Other	Maternal depression	Measured through the self-report Beck Depression Inventory (BDI; Beck et al, 1988). BDI total score ranges from 0 (low) to 63 (high).	Immediate post-intervention (6 weeks after the intervention started)
Other	Maternal depression	Measured through the self-report Beck Depression Inventory (BDI; Beck et al, 1988). BDI total score ranges from 0 (low) to 63 (high).	Follow-up (6 months adfter the intervention ended)
Other	Maternal anxiety	Measured through the state subscale of the self-report State-Trait Anxiety Inventory (STAI; Spielberger et al., 1983). The state subscale score ranges from 20 (low) to 80 (high).	Immediate post-intervention (6 weeks after the intervention started)
Other	Maternal anxiety	Measured through the state subscale of the self-report State-Trait Anxiety Inventory (STAI; Spielberger et al., 1983). The state subscale score ranges from 20 (low) to 80 (high).	Follow-up (6 months adfter the intervention ended)
Other	Infant temperament regulation	Measured through the mother-report Infant Behavior Questionnaire-Revised (Gartstein & Rothbart, 2003). The IBQ-R subscale of interest is the "Orienting/Regulatory Capacity". Its score ranges from 1 (low) to 7 (high).	Immediate post-intervention (6 weeks after the intervention started)
Other	Infant temperament regulation	Measured through the mother-report Infant Behavior Questionnaire-Revised (Gartstein & Rothbart, 2003). The IBQ-R subscale of interest is the "Orienting/Regulatory Capacity". Its score ranges from 1 (low) to 7 (high).	Follow-up (6 months adfter the intervention ended)
Primary	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	Infant emotional stress reactivity	It will be coded as infant negative emotionality through the infant's emotionality coding system (Brambilla et al., 2020; unpublished manual). The proportion of time in which the infant will be positive, neutral or negative will be obtained (score range for each emotion: 0 to 1).	Immediate post-intervention (6 weeks after the intervention started)
Secondary	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).	Follow-up (6 months adfter the intervention ended)
Secondary	Infant emotional stress reactivity	It will be coded as infant negative emotionality through the infant's emotionality coding system (Brambilla et al., 2020; unpublished manual). The proportion of time in which the infant will be positive, neutral or negative will be obtained (score range for each emotion: 0 to 1).	Follow-up (6 months adfter the intervention ended)