Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2023
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Family Nurture Intervention
The mother-child pair will be asked to talk and play with each other as they customarily do. 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, comfort touch, soothing words, and eye contact.
Nutrition and Play Intervention
Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.

Locations

Country Name City State
United States Norwalk Housing Authority Cos Cob Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Completed NCT03687879 - Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
Completed NCT03599648 - The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay N/A
Active, not recruiting NCT03641664 - FCT Study: Reducing the Need for Out-of-Home Placements N/A
Recruiting NCT06228950 - Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment N/A
Recruiting NCT05581914 - Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems N/A
Not yet recruiting NCT03260296 - Smartphones Addiction in Assiut University Students N/A
Recruiting NCT05280613 - The Family Check-Up in Autism Services N/A
Recruiting NCT05603000 - Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties N/A
Completed NCT04547192 - Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form N/A
Completed NCT05008354 - Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam Phase 4
Completed NCT03298724 - Teachers and Parents as Partners During Middle School N/A
Completed NCT03709472 - Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth N/A
Enrolling by invitation NCT04001140 - Enhancement of Emotion Regulation Skills in Adolescents N/A
Not yet recruiting NCT06417125 - Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children Phase 4
Active, not recruiting NCT05856435 - Tailoring CPP for the Foster Care Setting N/A
Completed NCT03694314 - Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study) N/A
Recruiting NCT04298437 - Addressing Depression and Positive Parenting Techniques (ADAPT) N/A
Recruiting NCT05667675 - Targeting Child Mental Health and Household Poverty N/A
Recruiting NCT05273320 - Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities Phase 1