Mental Disorders During PregnancyNCT02313493
Efficacy and Feasibility of Baby Triple P - a Pilot Study
A study testing Baby Triple P in people with Mental Disorders During Pregnancy, run by Ruhr University of Bochum.
Trial summary
In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders During Pregnancy
- What is being tested?
- Baby Triple P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Nov 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Becoming first time parent
- Participants have a basic level of German literacy which allows them to understand the Baby Triple P materials
- Unborn Baby is developing well and does not have a pre-diagnosed medical condition
Who cannot join
- Baby has a disability or pre-diagnosed medical condition.
- The parents are intellectually disabled
About this study
Official title: Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. It is expected that 78 couples of becoming first time parents are recruited. It is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.
Read the detailed description
In this pilot study, the efficacy and feasibility of the Baby Triple P parenting training is investigated in a pilot study using a randomized controlled trial. According to the efficacy of the parenting training, it is expected that parents in the training condition show higher scores on mental health scales (BSI-18) and quality of Partnership (PFB). Furthermore, it is expected that infants whose parents has taken part in the parenting training have lower severity ratings of regulatory disorders assessed with the Baby-DIPS diagnostic interview than infants of parents in the care as usual control condition.
- Conditions
- Mental Disorders During Pregnancy
- Being tested
- Baby Triple P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Triple PBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Baby Triple P parent training group | Experimental | The 8- session program delivered in four group sessions before birth and four telephone sessions after birth is developed for parents at the transition to parenthood or with a baby (up to 12 months of age). Receives: Behavioral: Baby Triple P |
| Care as usual control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of symptoms on the BSI 18 and the PFB-K
The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders. The relationship questionnaire (PFB-K) assess partnership satisfaction.
Measured: Before birth (T1), two months after birth (T2)
Severity rating (0-8) of regulatory problems in infants
Regulatory difficulties in crying, sleeping and feeding behavior in infants are assessed with a diagnostic interview (Baby-DIPS). The severity rating ranges from 0-8 (> 4 indicates a clinical referred disorder).
Measured: six months after birth (T3)
Secondary outcomes (2)
Quality of parenting
Parent-related behavior and cognitions are assessed with the Parenting Sense of Competence Scale (PSOC; T2,T3) with both parents and the Postpartum Bonding Questionnaire (PBQ;T2) only with mothers. Additionally, explorative questionnaires assess program specific parenting skills and educational elements as the number of soothing strategies the parents apply or the knowledge about an infants' development (T2, T3).
Measured: Two months after birth (T2), six month after birth (T3)
Number of symptoms on the EPDS, DASS-21 and the OSS-3
The Edinburgh Postnatal Depression Scale (EPDS, T2) is a rating scale for measuring the severity of postnatal depression symptoms. The Depression Anxiety Stress Scales (DASS-21) assess symptoms of depressions, anxiety and stress. The Oslo Social Support Scale (OSS-3) measures the subjective amount of social support the parents get.
Measured: Two months after birth (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startSep 2012
- Primary completionJul 2015 (estimated)
- Study completionNov 2015 (estimated)
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 Mental Disorders During PregnancyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukka Popp, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313493
- Sponsor's protocol ID
- RCT-Baby Triple P
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Popp L, Fuths S, Schneider S. The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual. Front Psychol. 2019 Oct 29;10:2425. doi: 10.3389/fpsyg.2019.02425. eCollection 2019.
PubMed 31736826Popp L, Schneider S. Attention placebo control in randomized controlled trials of psychosocial interventions: theory and practice. Trials. 2015 Apr 11;16:150. doi: 10.1186/s13063-015-0679-0.
PubMed 25872619
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02313493
- Acronym / sponsor ID
- RCT-Baby Triple P
- Conditions
- Mental Disorders During Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 10 Dec 2014 (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.
In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. It is expected that 78 couples of becoming first time parents are recruited. It is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.
Detailed description
In this pilot study, the efficacy and feasibility of the Baby Triple P parenting training is investigated in a pilot study using a randomized controlled trial. According to the efficacy of the parenting training, it is expected that parents in the training condition show higher scores on mental health scales (BSI-18) and quality of Partnership (PFB). Furthermore, it is expected that infants whose parents has taken part in the parenting training have lower severity ratings of regulatory disorders assessed with the Baby-DIPS diagnostic interview than infants of parents in the care as usual control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby Triple P parent training group | Experimental | Behavioral: Baby Triple PThe 8- session program delivered in four group sessions before birth and four telephone sessions after birth is developed for parents at the transition to parenthood or with a baby (up to 12 months of age). |
| Care as usual control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Becoming first time parent
- Participants have a basic level of German literacy which allows them to understand the Baby Triple P materials
- Unborn Baby is developing well and does not have a pre-diagnosed medical condition
Key exclusion criteria (2 listed)
- Baby has a disability or pre-diagnosed medical condition.
- The parents are intellectually disabled
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 |
|---|---|---|
| Baby Triple P | Behavioural | Baby Triple P parent training group |
Primary outcome
Number of symptoms on the BSI 18 and the PFB-K
Time frame: Before birth (T1), two months after birth (T2)
The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders. The relationship questionnaire (PFB-K) assess partnership satisfaction.
Severity rating (0-8) of regulatory problems in infants
Time frame: six months after birth (T3)
Regulatory difficulties in crying, sleeping and feeding behavior in infants are assessed with a diagnostic interview (Baby-DIPS). The severity rating ranges from 0-8 (> 4 indicates a clinical referred disorder).
2 secondary outcomes
Quality of parenting
Time frame: Two months after birth (T2), six month after birth (T3)
Number of symptoms on the EPDS, DASS-21 and the OSS-3
Time frame: Two months after birth (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Derived from this study: PubMed 31736826Popp L, Fuths S, Schneider S. The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual. Front Psychol. 2019 Oct 29;10:2425. doi: 10.3389/fpsyg.2019.02425. eCollection 2019.
- Derived from this study: PubMed 25872619Popp L, Schneider S. Attention placebo control in randomized controlled trials of psychosocial interventions: theory and practice. Trials. 2015 Apr 11;16:150. doi: 10.1186/s13063-015-0679-0.
Related trials for Mental Disorders During Pregnancy
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Recruiting
The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test
Pregnancy - Prenatal Testing
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Triple P in people with Mental Disorders During Pregnancy, run by Ruhr University of Bochum.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Dec 2014. 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?
Results are not available in the source record.
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?
Number of symptoms on the BSI 18 and the PFB-K (time frame: Before birth (T1), two months after birth (T2)). The study lists 2 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 NCT02313493, 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 11 Dec 2014.