Early Behavioral Intervention for Preterm Infants

NCT02379130 | Terminated

• 1 other identifier: AAAO2957
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of Family Nurture Intervention in preschool aged children between 2.5 and 4.5 years of age who were born prematurely and exhibit developmental deficits. The new approach is based on improving aspects of maternal nurturing behaviors as well as mother-child co-regulation, which are important to early development. Since young children with developmental deficits are often easily upset, mothers will be taught how to co-regulate with their child through comfort and calming interactions during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and long-term effects of this new approach to the nurture of children who were born early and demonstrate developmental problems and behavioral problems.

Conditions

Premature Birth

Keywords

Premature; Family Nurture Intervention

Outcome Measures

Primary Outcomes (1)

• Child Behavior Checklist (CBCL) Scale

  The Child Behavior Checklist (CBCL) is a device by which parents rate a child's problem behaviors and competencies. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The CBCL consists of 100 items.

  Baseline, 5 weeks, 6 months, 12 months

Secondary Outcomes (11)

• Salivary Cortisol Level

  Up to 3 years

• Oxytocin (OT) Level

  Up to 3 years

• Variance in Vagal Tone (High Frequency Heart Period Variability)

  Up to 3 years

• Strengths and Difficulties Questionnaire (SDQ) Score

  Up to 3 years

• Sleep Habits Questionnaire (SHQ) Score

  Up to 3 years

Study Arms (2)

Family Nurture Intervention Group

EXPERIMENTAL

Children in the FNI group will continue to attend any intervention programs that they are already enrolled in. In addition, they will be asked to attend 1 clinic visit per week for 6 weeks over the course of 12 weeks. During each visit, the mother-child will meet with trained Nurture Specialists. The Nurture Specialists will facilitate and encourage the mother and child to engage in nurturing and calming activities, including sustained touch, vocal soothing, and an odor cloth exchange. FNI families will be asked to participate in a 6 month post-enrollment follow-up visit and a 12 month post-enrollment follow-up visit.

Behavioral: Family Nurture Intervention

Play and Nutrition Intervention Group

ACTIVE COMPARATOR

Children in the PNI group will continue to attend any intervention programs that they are already enrolled in. They will be asked to attend 1 clinic visit per week for 6 weeks over the course of 12 weeks to meet with clinical personnel who will collect measures regarding the child's behavior and development. At each visit, study staff will meet with mothers to facilitate a lesson plan on appropriate play and nutrition. NPI families will be asked to participate in a 6 month post-enrollment follow-up visit and a 12 month post-enrollment follow-up visit.

Behavioral: Play and Nutrition Intervention

Interventions

Family Nurture Intervention BEHAVIORAL

The intervention begins with Block play. The child will be asked to play blocks with the mother during a eight minute video acquisition which will be coded for mother child interaction analysis. At the end of the video period the child will sit on the mother's lap. The pair will be asked to talk and play with each other as they customarily do. If the child becomes restless the mother will be coached by the nurture specialist to further engage the child with soothing and calming; the mother will be helped to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact. The mother will also be helped to verbally express her feelings toward her child and to tolerate her child's full range of feeling.

Also known as: FNI

Family Nurture Intervention Group

Play and Nutrition Intervention BEHAVIORAL

The intervention begins with Block play. The child will be asked to play blocks with the mother during a eight minute video acquisition which will be coded for mother child interaction analysis. At the end of the video period, the child and mother will play nutrition-focused games using the Healthy Habits for Life program designed by Michelle Obama.

Also known as: PNI

Play and Nutrition Intervention Group

Eligibility Criteria

• Age: 30 Months - 40 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant is a singleton (matched between groups)
• Mother is 18 years of age or older
• Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent)
• Child demonstrates developmental deficit (language, cognition, motor, emotion)

You may not qualify if:

• The child has severe congenital anomalies including chromosomal anomalies
• The child has severe motor or physical disability
• Mother currently presents with psychosis or is currently taking antipsychotic medication
• Mother and/or infant has a medical condition that precludes intervention components
• Mother and/or infant has a contagion that endangers other participants in the study

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center - Nuture Science Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Robert J Ludwig, BA

  Lab Manager, Nurture Science Progam, Columbia University Medical Center

  STUDY DIRECTOR

• Martha G Welch, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry in Pediatrics and Pathology and Cell Biology

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

US (1)