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Efficacy and Feasibility of Baby Triple P - a Pilot Study

NCT ID: NCT02313493

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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

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Mental Disorders During Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Baby Triple P parent training group

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).

Group Type EXPERIMENTAL

Baby Triple P

Intervention Type BEHAVIORAL

Care as usual control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Baby Triple P

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Lukka Popp

M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 31736826 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25872619 (View on PubMed)

Other Identifiers

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RCT-Baby Triple P

Identifier Type: -

Identifier Source: org_study_id