Behavior Problem Clinical Trial
Official title:
Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children
NCT number | NCT02970565 |
Other study ID # | AAAQ9547 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | May 2019 |
Verified date | February 2023 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
Status | Completed |
Enrollment | 106 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Months to 54 Months |
Eligibility | Inclusion Criteria: - Child is a singleton - Mother can speak in English or Spanish - Child is between the ages of 2 to 4 ½ years at date of enrollment - Mother is 18 years of age or older at the time of consent - Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better) - Child must reside 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 - 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 has any current involvement with Child Protective Services (Department of Children and Families) - Mother is pregnant - Mother and/or infant has a medical condition or contagion that precludes intervention components |
Country | Name | City | State |
---|---|---|---|
United States | Norwalk Housing Authority | Cos Cob | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Childhood Behavior Checklist (CBCL) Score | The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems. | Baseline, 6 months | |
Secondary | Co-regulation of Vagal Tone | Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records. | Up to 12 months | |
Secondary | Change in Maternal Anxiety and Depressive Symptoms | Mothers will complete various questionnaires measuring their mood and state. | Up to 12 months | |
Secondary | Changes in Welch Emotional Connection Scale | This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff. | Up to 12 months |
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