NCT03481452

Brief Summary

The present study aimed to determine whether infants disorders of regulation of states are associated with perinatal anxiety, and further to explore the efficacy of the behavioral intervention in enhancing positive interactions between mothers and their infants and thus ameliorating infants' disorders of regulation of states.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 3, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

November 30, 2017

Last Update Submit

April 2, 2018

Conditions

BehaviorAnxiety

Keywords

anxietyregulation of statesNBOHAMA

Outcome Measures

Primary Outcomes (1)

  • NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety

    The Hamilton Anxiety Scale(HAMA) was used to assess mothers anxiety state and whose score ≥14 were included. Meanwhile, Neonatal Behavioral Assessment Scale (NBAS) was used to assess infants neurobehavioral development and regulation of states from birth to 2 months. Regulation of states in the NBAS including four parts: cuddliness、consolability 、self-quieting and hand-to-mouth. Every part scores from 1 to 9, and the 1 represents worst and 9 for best. Higher scores of NBAS is associated with better regulation of states. Newborn Behavioral Observations (NBO) would be used to improve mother-infant dyad interaction and ameliorates infants disorders of regulation of states. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. Mother-newborn pairs serum would be collected to measure cortisol.

    up to 2 months

Study Arms (2)

psychotherapy intervention group

EXPERIMENTAL

NBO behavioral intervention would be used to improve mother-infant dyad interaction and infants' disorders of regulation of states.

Behavioral: psychotherapy

control group

NO INTERVENTION

No behavioral intervention would be used.

Interventions

psychotherapyBEHAVIORAL

NBO is an infant-focused, family relationship-based intervention measure, which aims to exhibit to parents infants' surprised ability, understand infants' strength and aspects needed to be improved, strength parents' parenting confidence, and promote sound development of infant-mother relationship.

Also known as: Neonatal Behavioral Observation (NBO)
psychotherapy intervention group

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • mother aged 18-40 years;
  • first-time mother, full-term and singleton pregnancy;
  • the Hamilton Anxiety Scale(HAMA) score ≥14;
  • the birth with no intrapartum complications;
  • Apgar score \> 8 at the first, fifth, and tenth minutes after birth.

You may not qualify if:

  • any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke, atrial fibrillation, peripheral arterial disease, and other severe diseases;
  • preterm infants (\< 37 weeks gestation);
  • multiple births;
  • infants with congenital anomalies, signs of illness, or high-risk factors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

BehaviorAnxiety Disorders

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Hui Li, PhD, MD

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Central Study Contacts

Hui Li, PhD, MD

CONTACT

+86 18991232133huili@mail.xjtu.edu.cn

zhongliang Zhu, PhD

CONTACT

+86 13991289992zlzhu@mail.xjtu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

March 29, 2018

Study Start

July 1, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

April 3, 2018

Record last verified: 2018-01

Locations

CN(1)