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

Primary Purpose

Neurodevelopmental Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telemedicine Video Feedback Intervention
Psychoeducational Booklet Intervention
Sponsored by
IRCCS National Neurological Institute "C. Mondino" Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurodevelopmental Disorders focused on measuring early family-centered intervention, telemedicine, video feedback, parenting, telerehabilitation, disability, psychomotor delay

Eligibility Criteria

1 Month - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mondino FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine Video Feedback Arm

Psychoeducational booklet arm

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
November 30, 2020
Last Updated
April 2, 2021
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04656483
Brief Title
Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)
Acronym
SPHERE
Official Title
Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders
Keywords
early family-centered intervention, telemedicine, video feedback, parenting, telerehabilitation, disability, psychomotor delay

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Video Feedback Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducational booklet arm
Arm Type
Active Comparator
Arm Description
Mothers 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.
Intervention Type
Other
Intervention Name(s)
Telemedicine Video Feedback Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Psychoeducational Booklet Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal sensitivity
Description
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).
Time Frame
Immediate post-intervention (6 weeks after the intervention started)
Secondary Outcome Measure Information:
Title
Infant emotional stress reactivity
Description
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).
Time Frame
Immediate post-intervention (6 weeks after the intervention started)
Title
Maternal sensitivity
Description
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).
Time Frame
Follow-up (6 months adfter the intervention ended)
Title
Infant emotional stress reactivity
Description
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).
Time Frame
Follow-up (6 months adfter the intervention ended)
Other Pre-specified Outcome Measures:
Title
Maternal Stress
Description
Measured through the self-report scale Parenting Stress Index (PSI; Abidin, 1983). PSI total score ranges from 36 (low) to 180 (high).
Time Frame
Immediate post-intervention (6 weeks after the intervention started)
Title
Maternal Stress
Description
Measured through the self-report scale Parenting Stress Index (PSI; Abidin, 1983). PSI total score ranges from 36 (low) to 180 (high).
Time Frame
Follow-up (6 months adfter the intervention ended)
Title
Maternal depression
Description
Measured through the self-report Beck Depression Inventory (BDI; Beck et al, 1988). BDI total score ranges from 0 (low) to 63 (high).
Time Frame
Immediate post-intervention (6 weeks after the intervention started)
Title
Maternal depression
Description
Measured through the self-report Beck Depression Inventory (BDI; Beck et al, 1988). BDI total score ranges from 0 (low) to 63 (high).
Time Frame
Follow-up (6 months adfter the intervention ended)
Title
Maternal anxiety
Description
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).
Time Frame
Immediate post-intervention (6 weeks after the intervention started)
Title
Maternal anxiety
Description
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).
Time Frame
Follow-up (6 months adfter the intervention ended)
Title
Infant temperament regulation
Description
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).
Time Frame
Immediate post-intervention (6 weeks after the intervention started)
Title
Infant temperament regulation
Description
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).
Time Frame
Follow-up (6 months adfter the intervention ended)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Livio Provenzi, PhD
Phone
0382/380287
Email
livio.provenzi@mondino.it
First Name & Middle Initial & Last Name or Official Title & Degree
Serena Grumi, PhD
Phone
0382/380287
Email
serena.grumi@mondino.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serena Grumi, PhD
Organizational Affiliation
IRCCS Mondino Foundation, Pavia, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Livio Provenzi, PhD
Organizational Affiliation
IRCCS Mondino Foundation, Pavia, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Mondino Foundation
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34907057
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.
Results Reference
derived

Learn more about this trial

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

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