Condition category
Pregnancy and Childbirth
Date applied
02/08/2010
Date assigned
04/10/2010
Last edited
12/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Becoming a parent is one of the most exciting journeys people undertake in their lifetime. However, although we know that the family environment is really important for the health and well-being of babies, new parents don’t receive much information about this. We are carrying out this study to evaluate the potential benefits of a new parenting programme called Triple P for Baby, which is specifically designed to support first-time parents. Triple P for Baby aims to reduce parental stress associated with becoming a first time parent; help parents develop confidence in their ability to deal with their new baby; increase the use of positive coping methods; improve the quality of the couple relationship; and extend parents’ social support networks.

Who can participate?
Couples expecting their first baby who are able to participate in the programme when between 20 and 35 weeks pregnant and are due to give birth at the Princess Royal Maternity Hospital in Glasgow.

What does the study involve?
We are evaluating Triple P for Baby to see if it benefits first-time parents. This means that we need to compare two groups of parents:
1. Parents who get normal NHS care during their pregnancy – the care as usual group
2. Parents who get normal NHS care PLUS Triple P for Baby – the Triple P group
If you take part in our study you will be in one of these groups. If you are in the Triple P for Baby group you and your partner will go to 4 group sessions before your baby is born. These groups are normally at the Princess Royal Maternity Hospital in Glasgow or at Glasgow Caledonian University and last about 2 hours. After your baby is born you will get 4 phone sessions. One of the people who ran your Triple P for Baby group will phone, you so you will know this person. Each phone call will last about half an hour.
If you are in the Care-as-Usual group you will attend all of the normal NHS antenatal and postnatal appointments. You won’t attend any Triple P for Baby sessions.
In order for us to evaluate the programme all participants in both groups are asked to complete surveys at four different stages; 1) at registration, 2) when your baby is 6-10 weeks old, 3) when your baby is 12 months old and 4) when your baby is 2 years old.

What are the possible benefits and risks of participating?
Triple P for Baby has the potential to improve family relationships, support infant development, prevent future behavioural and emotional problems in children and reduce psychological adjustment difficulties in new parents after the baby arrives.
The research will not involve procedures which could cause risk to the participating couples and their baby and there are no expected adverse events associated with the intervention.

Where is the study run from?
Parenting & Family Support Research Programme at Glasgow Caledonian University (UK)

When is the study starting and how long is it expected to run for?
July 2011 to December 2013

Who is funding the study?
National Health Service Greater Glasgow & Clyde (NHSGGC)

Who is the main contact?
Dr Elizabeth McGee

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth McGee

ORCID ID

Contact details

Glasgow Caledonian University
Department of Psychology
School of Life Sciences
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 OBA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Triple P for Baby: A longitudinal, randomised controlled trial of an intervention to help parents prepare for the transition to parenthood

Acronym

Study hypothesis

Triple P for Baby is a parenting programme that aims to prevent parental psychopathology by reducing parental stress associated with the transition to parenthood, increasing the use of adaptive emotional coping strategies, improving the quality of the couple relationship and by improving the extent and quality of the parents’ social support network.

Triple P for Baby also aims to reduce family risk factors by increasing parents' competence in dealing with common infant behaviours (e.g., crying), reducing parents’ use of coercive and punitive parenting practices (e.g., ‘shaken baby syndrome’), and by improving parents' communication about parenting issues. Finally, Triple P for Baby aims to promote healthy infant development by improving the parent-infant relationship during the first twelve months, increasing the quality of a safe and engaging environment for the infant, and by increasing parent’s confidence and competence in teaching infants new skills and behaviours.

Ethics approval

West of Scotland Research Ethics Committee, 01/06/2011, ref: 11/AL/0056

Study design

Two-arm longitudinal randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Parenting programme; parental stress

Intervention

Current interventions as of 18/06/2013:
Intervention Condition: Triple P for Baby:
Triple P for Baby consists of a total of eight sessions: four 2-hour groups sessions that are delivered prenatally, followed by four weekly 30-minute telephone consultations with the Triple P facilitator starting when the baby is six weeks old.Triple P for Baby targets the following key areas: fostering realistic expectations about the changes throughout the transition to parenthood as well as realistic expectations about infant’s behaviour and development, protecting the couple relationship, introducing parents to skills and competencies of dealing with infants, promoting increased confidence in new parents about their abilities as parents, and conveying a set of adaptive strategies for emotion regulation, such as relaxation or seeking social support. Data will be collected at four time points: T1) pre-intervention, T2) post-intervention (when baby is 6-10 weeks old, T3)12-month follow- up & T4) 24 month follow-up.

Care-as-Usual Control Condition:
Parents assigned to the CAU condition complete the assessment battery at the same four time points as the intervention group. Other than regarding issues of assessment, these parents will have no contact with the research team, but are free to access support from other community services and will be given appropriate referral information should they ask for assistance.

Previous interventions until 18/06/2013:
Intervention Condition: Triple P for Baby:
Triple P for Baby consists of a total of eight sessions: four 2-hour groups sessions that are delivered prenatally, followed by four weekly 30-minute telephone consultations with the Triple P facilitator starting when the baby is six weeks old. Triple P for Baby targets the following key areas: fostering realistic expectations about the changes throughout the transition to parenthood as well as realistic expectations about infant’s behaviour and development, protecting the couple relationship, introducing parents to skills and competencies of dealing with infants, promoting increased confidence in new parents about their abilities as parents, and conveying a set of adaptive strategies for emotion regulation, such as relaxation or seeking social support. Data will be collected at three time points: pre-intervention, post-intervention and at 3-month follow up.

Care-as-Usual Control Condition:
Parents assigned to the CAU condition complete the assessment battery at the same three time points as the intervention group. Once couples have successfully filled in all questionnaires, they will receive a copy of the Triple P for Baby parent workbook as a reward for their effort. Other than regarding issues of assessment, these parents will have no contact with the research team, but are free to access support from other community services and will be given appropriate referral information should they ask for assistance.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 18/06/2013:
The primary outcome measures for the research focus on parent level effects. Measures marked with * indicate measures used for mothers only.
1. Parent’s Mental Health: Depression Anxiety Stress Scale (DASS)
2. Life Satisfaction: Satisfaction with Life Scale (SWLS)
3. Parenting Satisfaction & Efficacy/ Global Self Efficacy: What Being The Parent of a Baby is like (WBPB) Evaluation subscale (12 items)
4. Task Specific Self Efficacy: Maternal Self Efficacy Scale (MSES)*
5. Conflict over Parenting: Parent Problem Checklist

Previous primary outcome measures until 18/06/2013:
The primary outcome measures for the research focus on parent level effects. Measures marked with * indicate measures used for mothers only.
1. Individual Adjustment/ Postnatal Depression: Edinburgh Postnatal Depression Scale (EPDS)
2. Life Satisfaction: Satisfaction with Life Scale (SWLS)
3. Parenting Satisfaction & Efficacy/ Global Self Efficacy: What Being The Parent of a Baby is like (WBPB) Evaluation subscale (12 items)
4. Task Specific Self Efficacy: Maternal Self Efficacy Scale (MSES)*
5. Conflict over Parenting: Parent Problem Checklist

Secondary outcome measures

The secondary outcomes for the research focus on child level, couple level and consumer satisfaction and engagement. Measures marked with * indicate measures used for mothers only.
1. Relationship Satisfaction: Frequency and Acceptability of Partner Behaviour Inventory (FAPBI)
2. Division of Tasks: Household Task Checklist and Household and Baby Care Task Checklist developed for this study
3. Infant Behaviour: Baby Diary developed for this study*
4. Baby Behaviour Inventory (BBI) developed for this study
5. Mother-infant attachment: Postpartum Bonding Instrument (PBI)*
6. Social Support: Social Support Scale developed for this study
7. Programme Satisfaction: Client Satisfaction Questionnaire (treatment group only)

Overall trial start date

01/06/2011

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Couples:
1. Experiencing a first pregnancy (between 20 and 35 weeks gestation)
2. Have a significant other (i.e. father, partner) who is prepared to be involved in the programme
3. Absence of an intellectual disability or severe psychopathology which would impair participant's understanding of the material presented in the programme
4. Basic level of English literacy
5. Absence of a diagnosed genetic disorder or disability in the baby

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160 couples

Participant exclusion criteria

1. Expectant mothers who are not experiencing a first time pregnancy
2. Expectant mothers who are less than 20 weeks and more than 35 weeks gestation
3. Expectant mothers who do not have a significant other (i.e. father, partner)
4. Expectant mothers and/or fathers who have an intellectual disabilty or severe psychopathology are excluded to the extent they would significantly impair participant's understanding of materials and content presented in the programme
5. Couples who do not have a basic level of English literacy in order to understand the programme with its associated exercises and materials
6. Couples, where the baby has been diagnosed with a genetic disorder or disability, as these would requires special considerations which are not covered as part of Standard Triple P for Baby

Recruitment start date

01/06/2011

Recruitment end date

30/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Caledonian University
Glasgow
G4 OBA
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

NHSGGC Children and Young People's Specialist Services
62 Templeton Street
Glasgow
G40 1DA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NHS Greater Glasgow and Clyde (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2016: No publications found, verifying study status with principal investigator. 18/06/2013: The following changes were made to the trial record: 1. All references to the 'Baby Triple P' programme were updated to 'Triple P for Baby' 2. The anticipated start date was updated from 30/10/2010 to 01/06/2011 3. The anticipated end date was updated from 30/04/2013 to 30/12/2013