ParentingNCT01931917
The Incredible Years Parents and Babies Program in Denmark
A study testing Incredible Years Parents and Babies Program in people with Parenting, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
Trial summary
The purpose of the pilot study is to examine the effects of the Incredible Years Baby Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for parents with infants aged 0-12 months. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Parenting
- What is being tested?
- Incredible Years Parents and Babies Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents with a child aged 0-4 months
- Parents are able to understand Danish at a basic level
Who cannot join
- Serious physical disability
- serious mental disability
- Child can not be placed in out of home care
Trial locations and contacts
1 site in 1 country.
Denmark1 site
SFI the Danish National Centre for Social Research
Copenhagen, 2100
About this study
Official title: A Randomised Controlled Pilot Trial of The Incredible Years Parents and Babies Program in Denmark
The purpose of the pilot study is to examine the effects of the Incredible Years Baby Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for parents with infants aged 0-12 months.
Read the detailed description
A randomised controlled effectiveness pilot trial of the Incredible Years Parents and Babies Program (IY baby)offered as a universal intervention in two municipalities in Denmark. 120 families will be randomised to IY Baby (intervention) og Usual Care (UC- control). Families recruited to the study have infants aged 0-4 months old. All first time mothers in one municipality and all mothers in another municipality are recruited. Outcomes are measured at 20 weeks post baseline and when the child is 18 months old. The aim of this trial is to estimate the effectiveness of the IY Baby program on parent and infant well-being, development and relationship and establish parameters for a definitive trial. In addition, the pilot study will also gather information on parent recruitment and participation to inform future research in this area.
- Conditions
- Parenting
- Being tested
- Incredible Years Parents and Babies Program, Usual Care
- Keywords
- Prevention, Parenting, Infants, Family programs, Early intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incredible Years Parents and Babies ProgramBehavioural
4-5 home visits by health visitor IY parents and babies program 8 sessions Group of mothers Health visitor station Extra visits by health visitor if needed
Usual CareBehavioural
4-5 home visits by health visitor Group of mothers Health visitor station Extra visits by health visitor if needed
| Study group | Role | What they receive |
|---|---|---|
| IY Parents and Babies Program | Experimental | In the Incredible Years Parents and Babies Program, parents learn how to help their babies feel loved, safe, and secure. They learn how to encourage their babies' physical and language development. The parenting group format fosters peer support networks and shared learning. Trained Incredible Years facilitators use video clips of real-life situational vignettes to support the training and stimulate parenting group discussions and practice exercises with their babies. The program is group based with 6-8 mothers and partners attending 8 2 hour sessions with their babies. Receives: Behavioral: Incredible Years Parents and Babies Program |
| Usual Care | Active comparator | Usual care consists of the elements that are being offered to all mothers in the participating municipalities which is 5 home visits by health visitors, a mothers group, a health nurse station and extra visits if needed. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karitane Parenting Confidence Scale (KPCS)
The KPCS measures perceived parenting self-efficacy (PPSE) in parents of children aged 0-12 months. High PPSE has been shown to act as a buffer against factors that can compromise a child's development, such as parental depression, anxiety, stress and relationship difficulties, and is associated with actual parenting competence and positive child outcomes
The KPCS is a short self-report instrument. It was developed in Australia primarily for health professionals experienced in working with parentcraft and psychosocial issues of early parenthood, including Maternal, Child and Family Health Nurses, and allied health and medical professionals.
Measured: Baseline, 20 weeks post intervention start
Parental Stress Scale (PSS)
Measured: 20 weeks post intervention start, child age 18 months
Secondary outcomes (12)
Sense of coherence (SOC13)
Measured: Baseline
Major Depression Inventory (MDI)
Measured: Baseline, 20 weeks post intervention start, child age 18 months
Ages and stages - Social-Emotional (ASQ-SE)
Measured: Baseline, 20 weeks post intervention start, child age 18 months
World health organisation well being index (WHO5)
Measured: Baseline, 20 weeks post intervention start, child age 18 months
Rosenberg self esteem (RSS)
Measured: 20 weeks post intervention start
Emotional Availability Scales (EAS) or Care Index
Video observation task measuring mother-infant attachment and relation
Measured: 20 weeks post intervention start
Mother and baby interaction scale (MABISC)
Measured: 20 weeks post intervention start
Strengths and Difficulties Questionnaire (SDQ)
Measured: child age 18 months
Cognitive development questionnaire (CDQ)
Measured: child age 18 months
Being a Mother (BaM13)
Measured: child age 18 months
Parental Reflective Functioning Questionnaire (PRFQ-1) short version
Measured: child age 18 months
Parenting Sense of Competence (PSOC)
Measured: child age 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Sponsor
- Investigators
- Maiken Pontoppidan, Principal investigator, VIVE - The Danish Center for Social Science Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931917
- Sponsor's protocol ID
- SFI 2570
- Status last verified
- Jan 2018
- First submitted
- 27 Aug 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Pontoppidan M, Thorsager M, Steenhoff T. Parent-child Relationship Outcomes of the Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. Scand J Child Adolesc Psychiatr Psychol. 2022 Jun 7;10(1):40-52. doi: 10.2478/sjcapp-2022-0004. eCollection 2022 Jan.
PubMed 35799975Pontoppidan M, Klest SK, Sandoy TM. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. PLoS One. 2016 Dec 14;11(12):e0167592. doi: 10.1371/journal.pone.0167592. eCollection 2016.
PubMed 27974857Pontoppidan M. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial. Trials. 2015 Sep 2;16:386. doi: 10.1186/s13063-015-0859-y.
PubMed 26329163
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Pilot Trial of The Incredible Years Parents and Babies Program in Denmark
- ClinicalTrials.gov ID
- NCT01931917
- Acronym / sponsor ID
- SFI 2570
- Conditions
- Parenting
- Keywords
- Prevention, Parenting, Infants, Family programs, Early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- Aug 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the pilot study is to examine the effects of the Incredible Years Baby Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for parents with infants aged 0-12 months.
Detailed description
A randomised controlled effectiveness pilot trial of the Incredible Years Parents and Babies Program (IY baby)offered as a universal intervention in two municipalities in Denmark. 120 families will be randomised to IY Baby (intervention) og Usual Care (UC- control). Families recruited to the study have infants aged 0-4 months old. All first time mothers in one municipality and all mothers in another municipality are recruited. Outcomes are measured at 20 weeks post baseline and when the child is 18 months old. The aim of this trial is to estimate the effectiveness of the IY Baby program on parent and infant well-being, development and relationship and establish parameters for a definitive trial. In addition, the pilot study will also gather information on parent recruitment and participation to inform future research in this area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IY Parents and Babies Program | Experimental | Behavioral: Incredible Years Parents and Babies ProgramIn the Incredible Years Parents and Babies Program, parents learn how to help their babies feel loved, safe, and secure. They learn how to encourage their babies' physical and language development. The parenting group format fosters peer support networks and shared learning. Trained Incredible Years facilitators use video clips of real-life situational vignettes to support the training and stimulate parenting group discussions and practice exercises with their babies. The program is group based with 6-8 mothers and partners attending 8 2 hour sessions with their babies. |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care consists of the elements that are being offered to all mothers in the participating municipalities which is 5 home visits by health visitors, a mothers group, a health nurse station and extra visits if needed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents with a child aged 0-4 months
- Parents are able to understand Danish at a basic level
Key exclusion criteria (3 listed)
- Serious physical disability
- serious mental disability
- Child can not be placed in out of home care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incredible Years Parents and Babies Program4-5 home visits by health visitor IY parents and babies program 8 sessions Group of mothers Health visitor station Extra visits by health visitor if needed | Behavioural | IY Parents and Babies Program |
| Usual Care4-5 home visits by health visitor Group of mothers Health visitor station Extra visits by health visitor if needed | Behavioural | Usual Care |
Primary outcome
Karitane Parenting Confidence Scale (KPCS)
Time frame: Baseline, 20 weeks post intervention start
The KPCS measures perceived parenting self-efficacy (PPSE) in parents of children aged 0-12 months. High PPSE has been shown to act as a buffer against factors that can compromise a child's development, such as parental depression, anxiety, stress and relationship difficulties, and is associated with actual parenting competence and positive child outcomes The KPCS is a short self-report instrument. It was developed in Australia primarily for health professionals experienced in working with parentcraft and psychosocial issues of early parenthood, including Maternal, Child and Family Health Nurses, and allied health and medical professionals.
Parental Stress Scale (PSS)
Time frame: 20 weeks post intervention start, child age 18 months
12 secondary outcomes
Sense of coherence (SOC13)
Time frame: Baseline
Major Depression Inventory (MDI)
Time frame: Baseline, 20 weeks post intervention start, child age 18 months
Ages and stages - Social-Emotional (ASQ-SE)
Time frame: Baseline, 20 weeks post intervention start, child age 18 months
World health organisation well being index (WHO5)
Time frame: Baseline, 20 weeks post intervention start, child age 18 months
Rosenberg self esteem (RSS)
Time frame: 20 weeks post intervention start
Emotional Availability Scales (EAS) or Care Index
Time frame: 20 weeks post intervention start
Mother and baby interaction scale (MABISC)
Time frame: 20 weeks post intervention start
Strengths and Difficulties Questionnaire (SDQ)
Time frame: child age 18 months
Cognitive development questionnaire (CDQ)
Time frame: child age 18 months
Being a Mother (BaM13)
Time frame: child age 18 months
Parental Reflective Functioning Questionnaire (PRFQ-1) short version
Time frame: child age 18 months
Parenting Sense of Competence (PSOC)
Time frame: child age 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Derived from this study: PubMed 35799975Pontoppidan M, Thorsager M, Steenhoff T. Parent-child Relationship Outcomes of the Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. Scand J Child Adolesc Psychiatr Psychol. 2022 Jun 7;10(1):40-52. doi: 10.2478/sjcapp-2022-0004. eCollection 2022 Jan.
- Derived from this study: PubMed 27974857Pontoppidan M, Klest SK, Sandoy TM. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. PLoS One. 2016 Dec 14;11(12):e0167592. doi: 10.1371/journal.pone.0167592. eCollection 2016.
- Derived from this study: PubMed 26329163Pontoppidan M. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial. Trials. 2015 Sep 2;16:386. doi: 10.1186/s13063-015-0859-y.
- Paper - post intervention outcomesLink provided by the sponsor.
- Trial protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiken Pontoppidan principal investigator
VIVE - The Danish Center for Social Science Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incredible Years Parents and Babies Program in people with Parenting, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karitane Parenting Confidence Scale (KPCS) (time frame: Baseline, 20 weeks post intervention start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931917, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.