NCT02394444

Brief Summary

The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

June 1, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

3.7 years

First QC Date

February 5, 2015

Last Update Submit

March 16, 2015

Conditions

Preterm BirthParentingMental Health Wellness 1Parent-Child RelationChild Development

Keywords

Intervention programParenting stressParental mental healthPreterm infant's development

Outcome Measures

Primary Outcomes (3)

  • Change in the "Parent-Infant Relationship" assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting

    assessments at each time point: at the corrected ages of 3 and 18 months

  • Change in "Parent-Infant Relationship" assessed by "R" interview scores : assessing level of parental self-esteem

    assessments at each time point: at the corrected ages of 3 and 18 months

  • "Parent-Infant Relationship" assessed by Q-sort attachment scores : assessing the score of the attachment security of the infant at the corrected age of 18 months

    We needed to use a variety of measures because these measures had to be tailored to the child's stage of development. To ensure the relative strength conclusion on the treatment effect, the statistic analyses of test scores each time point were made using bonefferoni correction for multiple comparisons. Parenting Stress Index ( PSI-SF), "R" interview and Q-sort attachment were tests based on the infant's age at different assessment periods.

    assessment at the corrected age of 18 months

Secondary Outcomes (6)

  • Change in "Parental Mental Health" assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress

    assessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months

  • Change in "Parental Mental Health" assessed by Beck Depression Inventory (BDI) scores: assessing level of depression

    assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months

  • Change in "Parental Mental Health" assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression

    assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months

  • "Infant Development" assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development

    assessments at 44 weeks gestational age

  • Change in "Infant Development"assessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ)

    assessments at each time point: at the corrected ages of 3, 9 and 18 months

  • +1 more secondary outcomes

Study Arms (3)

Preterm intervention TRT group

EXPERIMENTAL

Parents with premature infants received the intervention called "Triadic parent-infant's Relationship Therapy" (TRT) : the psychological intervention included home visits twice month during the first four months and then monthly visits in the neonatal ward until the 18 months corrected age resulting in a total of 22 visits during the whole intervention; TRT gave attention to emotional distress and the promotion of parenting skills and attachment security; The three sessions of intervention targeted objectives specific to each child's development; A basic manual was designed to ensure uniformity of the defined themes during each session

Other: Triadic parent-infant Relationship Therapy (TRT)

Preterm control group

NO INTERVENTION

Parents with premature infants without intervention program TRT (Triadic parent-infant's Relationship Therapy) received routine follow-up medical care with monthly visits to a practitioner for the first six months and then very three months

Full-term control group

NO INTERVENTION

Parents with full-term infants without intervention program TRT

Interventions

Triadic parent-infant Relationship Therapy (TRT)OTHER

22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.

Also known as: TRT
Preterm intervention TRT group

Eligibility Criteria

Age28 Weeks - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days
  • Enrolled the parents were required to be French speakers, over 18 years old and residing within 50-kilometres radius of hospital

You may not qualify if:

  • preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period
  • parents without known psychiatric history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Guillois B, Castel S, Beunard A, Blaizot X, Creveuil C, Proia-Lelouey N. [Effect of early intervention programs on neurobehavioral outcome in premature infants after discharge]. Arch Pediatr. 2012 Sep;19(9):990-7. doi: 10.1016/j.arcped.2012.06.004. Epub 2012 Aug 9. French.

    PMID: 22884746BACKGROUND

  • Sizun, J., Guillois, B., Casper, C., Thiriez, G., Kuhn, P. 2014.Soins de développement en période néonatale.De la recherche à la pratique. Springer.

    BACKGROUND

  • This study was submitted at the 52nd Annual Meeting of the European Society for Pediatric Research at Newcastle (october 15-17th 2011)

    BACKGROUND

  • This study was presented in Communication at the 42nd Journées Nationales de Néonatologie in Paris, march 2012.

    BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Bernard Guillois, PhD

    Neonatology Department, Hospital and university center, Caen

    PRINCIPAL INVESTIGATOR

  • Sophie Castel, MD

    Neonatology Department, Hospital and university center, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

March 20, 2015

Study Start

June 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 20, 2015

Record last verified: 2015-03