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Preterm BirthIDEXNCT02394444

Impact of an Intervention Program on Parenting Stress After Preterm Birth

A study testing Triadic parent-infant Relationship Therapy (TRT) in people with Preterm Birth and Parenting, run by University Hospital, Caen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 to 35 weeks
Conditions the study is for
Preterm Birth, Parenting, Mental Health Wellness 1
What is being tested?
Triadic parent-infant Relationship Therapy (TRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
No sites listed yet
Study dates
Jun 2006to Feb 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 to 35 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Impact of a Psychological Post-hospital Intervention Aimed at Facilitating Parents-child Attachment and Preventing the Preterm Infants' Psycho-emotional, Social and Cognitive Disturbances

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.

Read the detailed description

Due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. Several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). These can cause lasting parent-child interactions disruption and jeopardize the attachment process. These early link distortions may hinder the infant's behavioral-emotional and cognitive development. Prematurity psychological consequences may negatively influence biomedical risks. Understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well.

Post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

Being tested
Triadic parent-infant Relationship Therapy (TRT)
Keywords
Intervention program, Parenting stress, Parental mental health, Preterm infant's development
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triadic parent-infant Relationship Therapy (TRT)Other

    Also called TRT

    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.

Study groups in NCT02394444
Study groupRoleWhat they receive
Preterm intervention TRT groupExperimentalParents 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
Receives: Other: Triadic parent-infant Relationship Therapy (TRT)
Preterm control groupNo interventionParents 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 groupNo interventionParents with full-term infants without intervention program TRT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

  3. "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.

    Measured: assessment at the corrected age of 18 months

Secondary outcomes (6)

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

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

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

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

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

    The BDI and the EPDS are both based on the frequency of depressive symptoms The statistic analyses were used to compare the evolution of all of the other scores over time.

    The Post-Traumatic Stress Disorder (PTSD), Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS) were tests that were resorted to enable us to examine and monitor the preterm birth traumatic impact on parental mental health.

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

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

    Measured: assessments at 44 weeks gestational age

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

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

  6. Change in "Infant Development"assessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities

    The statistic analyses were used to compare the evolution of all of the other scores over time.

    The Neonatal Behavioral Assessment Scale (NBAS),the Brunet-Lezine Psychomotor Development Scale and Infant Behavioral Symptom were tests that were complementary and enable us to assess infant's various facets of socio-emotional, motor and cognitive development at different stage of development.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2015 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02394444
Sponsor's protocol ID
05-094
Other IDs
2006/0215, 2005-36
Acronym
IDEX
Status last verified
Mar 2015
First submitted
5 Feb 2015
Last updated
20 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22884746

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

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Triadic parent-infant Relationship Therapy (TRT) in people with Preterm Birth and Parenting, run by University Hospital, Caen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the "Parent-Infant Relationship" assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting (time frame: assessments at each time point: at the corrected ages of 3 and 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02394444, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.

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