Mental Disorders During Pregnancy Clinical Trial
Official title:
Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
| Verified date | December 2014 |
| Source | Ruhr University of Bochum |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ruhr University Bochum |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 78 |
| Est. completion date | November 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Baby has a disability or pre-diagnosed medical condition. - The parents are intellectually disabled |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ruhr University of Bochum |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Before birth (T1), two months after birth (T2) | No |
| Primary | 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). | six months after birth (T3) | No |
| Secondary | 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). | Two months after birth (T2), six month after birth (T3) | No |
| Secondary | 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. | Two months after birth (T2) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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