CompletedNot Applicable

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

Italy45 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range

3 Months – 18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

ELIGIBILITY CRITERIA FOR INFANTS Inclusion Criteria: * Infants with equivalent age range 3-to-18-months * Mild to moderate psychomotor delay Exclusion Criteria: * Presence of severe sensorial (auditory, visual) deficits * Genetic syndrome with known functional implications for the epigenetic regulation of target genes ELIGIBILITY CRITERIA FOR MOTHERS Inclusion Criteria: * Mastery of Italian language * Age \> 18 years * Living with the father of the infant Exclusion Criteria: * Documented mental disorder * Documented disability

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in maternal sensitivity

Timeframe: 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

Trial details

NCT IDNCT03853564

SponsorIRCCS Eugenio Medea

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-05

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