Efficacy and Feasibility of Baby Triple P - a Pilot Study
Primary Purpose
Mental Disorders During Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baby Triple P
Sponsored by
About this trial
This is an interventional prevention trial for Mental Disorders During Pregnancy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Baby Triple P parent training group
Care as usual control group
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT02313493
First Posted
December 7, 2014
Last Updated
December 9, 2014
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT02313493
Brief Title
Efficacy and Feasibility of Baby Triple P - a Pilot Study
Official Title
Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders During Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baby Triple P parent training group
Arm Type
Experimental
Arm Description
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).
Arm Title
Care as usual control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Baby Triple P
Primary Outcome Measure Information:
Title
Number of symptoms on the BSI 18 and the PFB-K
Description
The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders. The relationship questionnaire (PFB-K) assess partnership satisfaction.
Time Frame
Before birth (T1), two months after birth (T2)
Title
Severity rating (0-8) of regulatory problems in infants
Description
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).
Time Frame
six months after birth (T3)
Secondary Outcome Measure Information:
Title
Quality of parenting
Description
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).
Time Frame
Two months after birth (T2), six month after birth (T3)
Title
Number of symptoms on the EPDS, DASS-21 and the OSS-3
Description
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.
Time Frame
Two months after birth (T2)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
31736826
Citation
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.
Results Reference
derived
PubMed Identifier
25872619
Citation
Popp 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.
Results Reference
derived
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Efficacy and Feasibility of Baby Triple P - a Pilot Study
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