- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048720
Norwalk Feasibility Study
Norwalk Drop-In Family Nurture Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Family Nurture Intervention (FNI) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, the ability of the mother-child dyad to promote optimal development is dependent on their ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both the mother and the child.
This study aims to investigate the feasibility and short term effects of participation in the Family Nurture Intervention for preschool aged children with developmental and behavior problems. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to co-regulate with each other during weekly group sessions with the support of study staff. Intervention sessions will occur over the course of eight weeks, and each mother will decide how many sessions to attend.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Norwalk, Connecticut, United States, 06854
- Norwalk Housing Authority
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mother is fluent in English or Spanish
- Mother is 18 years of age or older at the time of consent
- Mother-child pair does not demonstrate emotional connection as measured by the WECS
- Child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study AAAQ9547
- Child resides with mother
Exclusion Criteria:
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- The child has a diagnosis of Autism Spectrum Disorder
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Current maternal drug and/or alcohol abuse
- Mother is more than four months pregnant
- Mother and/or infant has a medical condition or contagion that precludes intervention components
- Mother is unable to commit to study schedule
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Family Nurture Intervention (FNI)
FNI sessions will be held once a week in the afternoon for eight weeks.
Participants will take part in FNI group therapy with their child alongside other mother-child pairs.
One to two staff members will lead FNI sessions.
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The mother-child pair will be asked to talk and play with each other as the pair customarily does.
If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact.
Each dyad will be offered eight group FNI sessions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mother-child session interest
Time Frame: 8 weeks
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Study staff will track interest level and engagement with FNI through weekly forms and notes; mothers will be asked to give feedback on their experience of the study at the completion of eight weeks.
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8 weeks
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Change in videotaped Welch Lap Test
Time Frame: 8 weeks
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Mother-child 5-minute videotaped interactions, recorded weekly after each session, will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS). The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually. |
8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS0112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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