Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities

NCT03853564 | Completed DMC

• 1 other identifier: RF-2016-02361884
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

Infants with developmental disabilities present a high risk of behavioral and socio-emotional problems. Their parents are themselves at risk of developing emotional and affective disorders which can impact the quality of the interaction with the infant. Early parenting empowerment focused on parent-infant interaction are beneficial in supporting infants development and parental adjustment. By using a multi-layer approach to outcomes assessment (i.e., behavioral, neuroendocrine and epigenetic outcomes), the present longitudinal, multi-center, change-promoting clinical trial is aimed at assessing the effectiveness of an early parenting empowerment intervention based on video-feedback technique to support maternal responsiveness and the socio-emotional development of infants with developmental disabilities.

Conditions

Epigenomics; Developmental Disability; Early Intervention; Parent-Child Relations

Keywords

DNA methylation; Epigenetic regulation; Video-feedback intervention; Developmental disability; Cerebral palsy; Genetic syndromes; Parent-infant interaction; Early intervention; Neuroendocrine regulation

Outcome Measures

Primary Outcomes (2)

• Change in maternal sensitivity

  Coded micro-analitically from videotapes of mother-infant interactions.

  Through study completion: at intervention start (Baseline, T0), 2 months after intervention start (post-intervention, T1), 3 months after intervention end (follow-up, T2), and 6 months after intervention end (follow-up, T3)

• Change in infant behavioral regulation

  Coded micro-analitically from videotapes of mother-infant interactions.

  Through study completion: at intervention start (Baseline, T0), 2 months after intervention start (post-intervention, T1), 3 months after intervention end (follow-up, T2), and 6 months after intervention end (follow-up, T3)

Secondary Outcomes (2)

• Change in hormones salivary concentrations

  Through study completion: at intervention start (Baseline, T0), 2 months after intervention start (post-intervention, T1), 3 months after intervention end (follow-up, T2), and 6 months after intervention end (follow-up, T3)

• Change in DNA methylation status

  Through study completion: at intervention start (Baseline, T0), 2 months after intervention start (post-intervention, T1), 3 months after intervention end (follow-up, T2), and 6 months after intervention end (follow-up, T3)

Other Outcomes (1)

• Feasibility and acceptability

  Through study completion, 2 months after intervention start (post-intervention, T1)

Study Arms (2)

Video-Feedback Group (VFG)

EXPERIMENTAL

Dyads of mothers and their infant with developmental disability who are exposed to the video-feedback intervention focused on different domains of mother-infant quality of interaction (number of sessions: 6).

Behavioral: Video-Feedback Intervention

Phone-Call Group (PCG)

SHAM COMPARATOR

Dyads of mothers and their infant with developmental disability who are not exposed to the video-feedback intervention, instead they receive phone calls focused on obtaining descriptions of different domains of infant behavioral development (number of sessions: 6)

Other: Phone-Call Intervention

Interventions

Video-Feedback Intervention BEHAVIORAL

Mothers and infants of the VFG arm will participate to a 6-session video-feedback intervention structured as follows: 4 sessions of video-review discussions with a trained clinician + 2 sessions of integrative intervention aimed at translating into practical caregiving the insights developed during the video-review discussions.

Video-Feedback Group (VFG)

Phone-Call Intervention OTHER

Mothers of the PCG arm will participate in 6-session of telephone call during which a trained collaborator will ask details on different domains of infants behavioral development.

Phone-Call Group (PCG)

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with equivalent age range 3-to-18-months
• Mild to moderate psychomotor delay

You may not qualify if:

• Presence of severe sensorial (auditory, visual) deficits
• Genetic syndrome with known functional implications for the epigenetic regulation of target genes
• ELIGIBILITY CRITERIA FOR MOTHERS
• Mastery of Italian language
• Age \> 18 years
• Living with the father of the infant
• Documented mental disorder
• Documented disability

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Fondazione Istituto Neurologico Casimiro Mondino: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (3)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Università degli Studi di Brescia

Brescia, 25123, Italy

Location

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, 27100, Italy

Location

Related Publications (1)

• Montirosso R, Rosa E, Giorda R, Fazzi E, Orcesi S, Cavallini A, Provenzi L; Early Intervention Study Group. Early Parenting Intervention - Biobehavioral Outcomes in infants with Neurodevelopmental Disabilities (EPI-BOND): study protocol for an Italian multicentre randomised controlled trial. BMJ Open. 2020 Jul 21;10(7):e035249. doi: 10.1136/bmjopen-2019-035249.

  PMID: 32699128 DERIVED

MeSH Terms

Conditions

Developmental Disabilities; Cerebral Palsy; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rosario Montirosso, PsyD

  IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 25, 2019
• Study Start: September 1, 2019
• Primary Completion: February 5, 2023
• Study Completion: April 5, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)