Posttraumatic Stress DisorderJOINNCT02736136
An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth
A study testing joint observation and video feedback in people with Posttraumatic Stress Disorder and Stress, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Stress, Anxiety
- What is being tested?
- joint observation and video feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to Aug 2020
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers of very preterm infants born between 28 and 32 weeks of gestation
- Infant aged up to 8 weeks
Who cannot join
- Do not speak French sufficiently well to participate in assessments
- Have established intellectual disability or psychotic illness
- Infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neonatology Service, University Hospital Lausanne
Lausanne, Canton of Vaud, 1011
About this study
This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.
- Conditions
- Posttraumatic Stress Disorder, Stress, Anxiety, Depression
- Being tested
- joint observation and video feedback
- Keywords
- maternal parenting self-efficacy, parental stress, maternal sensitivity, mother-infant bond
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint observation and video feedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Joint observation and video feedback plus usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction) Receives: Behavioral: joint observation and video feedback |
| Control | No intervention | Usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Maternal Parenting Self-Efficacy tool
Measured: 1 month
Secondary outcomes (10)
Posttraumatic Diagnostic Scale
Measured: 1 month, 6 months
Parental Stressor Scale: Neonatal Intensive Care Unit
Measured: 1 month, 6 months
Parental Stress Index - Short form
Measured: 1 month, 6 months
Hospital Anxiety and Depression Scale
Measured: 1 month, 6 months
Edinburgh Postnatal Depression Scale
Measured: 1 month, 6 months
Mother-to-Infant Bonding Scale
Measured: 1 month, 6 months
Infant Behaviour Questionnaire - Revised very short form
Measured: 1 month, 6 months
Emotional Availability Scale
Measured: 6 months
Perceived Maternal Parental Self-Efficacy tool
Measured: 6 months
CARE-Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antje Horsch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antje Horsch, DClinPsych, Principal investigator, Clinical and Research Psychologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736136
- Sponsor's protocol ID
- 496/15
- Acronym
- JOIN
- Status last verified
- Mar 2022
- First submitted
- 4 Apr 2016
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lovey O, Bickle-Graz M, Morisod Harari M, Horsch A, Schneider J; JOIN Research Consortium. The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial. Children (Basel). 2022 Sep 13;9(9):1380. doi: 10.3390/children9091380.
PubMed 36138689Schneider J, Borghini A, Morisod Harari M, Faure N, Tenthorey C, Le Berre A, Tolsa JF, Horsch A; JOIN Research Consortium. Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care. BMJ Open. 2019 Mar 30;9(3):e026484. doi: 10.1136/bmjopen-2018-026484.
PubMed 30928952
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth
- ClinicalTrials.gov ID
- NCT02736136
- Acronym / sponsor ID
- JOIN / 496/15
- Conditions
- Posttraumatic Stress Disorder, Stress, Anxiety, Depression
- Keywords
- maternal parenting self-efficacy, parental stress, maternal sensitivity, mother-infant bond
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: joint observation and video feedbackJoint observation and video feedback plus usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction) |
| Control | No intervention | –Usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mothers of very preterm infants born between 28 and 32 weeks of gestation
- Infant aged up to 8 weeks
Key exclusion criteria (3 listed)
- Do not speak French sufficiently well to participate in assessments
- Have established intellectual disability or psychotic illness
- Infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| joint observation and video feedback | Behavioural | Intervention |
Primary outcome
Perceived Maternal Parenting Self-Efficacy tool
Time frame: 1 month
10 secondary outcomes
Posttraumatic Diagnostic Scale
Time frame: 1 month, 6 months
Parental Stressor Scale: Neonatal Intensive Care Unit
Time frame: 1 month, 6 months
Parental Stress Index - Short form
Time frame: 1 month, 6 months
Hospital Anxiety and Depression Scale
Time frame: 1 month, 6 months
Edinburgh Postnatal Depression Scale
Time frame: 1 month, 6 months
Mother-to-Infant Bonding Scale
Time frame: 1 month, 6 months
Infant Behaviour Questionnaire - Revised very short form
Time frame: 1 month, 6 months
Emotional Availability Scale
Time frame: 6 months
Perceived Maternal Parental Self-Efficacy tool
Time frame: 6 months
CARE-Index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 36138689Lovey O, Bickle-Graz M, Morisod Harari M, Horsch A, Schneider J; JOIN Research Consortium. The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial. Children (Basel). 2022 Sep 13;9(9):1380. doi: 10.3390/children9091380.
- Derived from this study: PubMed 30928952Schneider J, Borghini A, Morisod Harari M, Faure N, Tenthorey C, Le Berre A, Tolsa JF, Horsch A; JOIN Research Consortium. Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care. BMJ Open. 2019 Mar 30;9(3):e026484. doi: 10.1136/bmjopen-2018-026484.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Exercise and Emotional Learning in Posttraumatic Stress Disorder
PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Horsch, DClinPsych principal investigator
Clinical and Research Psychologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint observation and video feedback in people with Posttraumatic Stress Disorder and Stress, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Perceived Maternal Parenting Self-Efficacy tool (time frame: 1 month). 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 NCT02736136, which also lists 2 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 25 Mar 2022.