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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
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Disorders During Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 7, 2014
    Last Updated
    December 9, 2014
    Sponsor
    Ruhr University of Bochum
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    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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