INFANT HEALTH- Promoting Mental Health and Healthy Weight in Infancy Through Sensitive Parenting
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ClinicalTrials.gov Identifier: NCT04601779 |
Recruitment Status :
Active, not recruiting
First Posted : October 26, 2020
Last Update Posted : December 6, 2023
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Mental health problems and overweight often co-occur, they have their origin in early childhood and new research evidence suggest a key role of cognitive, emotional and behavioral regulation in the early developmental trajectories and points to the benefits of intervention in infancy that builds on strategies of sensitive parenting.
The research group behind this project has developed the PUF program (PUF: In Danish: 'Psykisk Udvikling og Funktion') to target infants' mental health and development within the settings of community health nurses. Still, measures are lacking that address the infants most vulnerable regarding the development and progression of mental health problems and overweight.
In this project, we develop and test a new intensified intervention to address major cognitive and regulatory vulnerabilities identified at child age 9-10 months and adapted to the settings of community health nurses. The intervention is created as an add-on to the PUF-program, using an evidence-based method to promote sensitive parenting, the Video-based Intervention to Promote Positive Parenting (VIPP). The new intervention VIPP-PUF comprises six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The intervention builds on teaching the health nurses to promote parents' sensitivity to meet the infants' cognitive and regulatory vulnerabilities, and it takes in account the needs of psycho-socially disadvantaged families.
The Infant Health project is conducted in sixteen municipalities across Denmark. We use the Intervention Mapping approach as the study frame and integrate the best practice of community health nurses. The efficacy of the VIPP-PUF intervention is examined in a randomized controlled step-wedge design, in which approximately 1.000 children are followed up to the age of 24 months.
The VIPP-PUF intervention is hypothesized to reduce mental health problems at ages 24 months among infants with high levels of cognitive and regulatory problems at age 9-10 months, (primary outcome). Also, it is hypothesized that among children with high levels of cognitive and regulatory vulnerabilities at age 9-10 months, adding the VIPP-PUF intervention to treatment as usual at age 9-10 months, will reduce infants' cognitive and regulatory problems; promote healthy weight development; reduce parents' experiences of stress; promote sensitive parenting and promote parents' feeling of competence and relatedness.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infant Mental Health Parenting Parent-Child Relations | Behavioral: VIPP-PUF | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 446 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | INFANT HEALTH- Supporting Infants' Mental Health and Healthy Weight Development Through Community Health Nurses' Promoting Sensitive Parenting |
Actual Study Start Date : | August 16, 2021 |
Estimated Primary Completion Date : | May 17, 2025 |
Estimated Study Completion Date : | June 30, 2026 |
Arm | Intervention/treatment |
---|---|
Cluster I
Cluster I is randomized to start the VIPP-PUF intervention phase May 1, 2022
|
Behavioral: VIPP-PUF
The VIPP-PUF Intervention is developed as an add-on to the existing PUF-program to address infants with major cognitive and regulatory vulnerabilities identified at age 9-10 months and adapted to the settings of community health nurses. The intervention (VIPP-PUF) will be created from an evidence-based method, the Video-based Intervention to Promote Positive Parenting (VIPP), to comprise six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The VIPP -PUF builds on teaching the health nurses to promote parents' sensitivity to meet infants' cognitive and regulatory vulnerabilities, while taking in account the particular needs of families of psycho-social disadvantage. |
Cluster II
Cluster II is randomized to start the VIPP-PUF intervention phase November 1, 2022
|
Behavioral: VIPP-PUF
The VIPP-PUF Intervention is developed as an add-on to the existing PUF-program to address infants with major cognitive and regulatory vulnerabilities identified at age 9-10 months and adapted to the settings of community health nurses. The intervention (VIPP-PUF) will be created from an evidence-based method, the Video-based Intervention to Promote Positive Parenting (VIPP), to comprise six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The VIPP -PUF builds on teaching the health nurses to promote parents' sensitivity to meet infants' cognitive and regulatory vulnerabilities, while taking in account the particular needs of families of psycho-social disadvantage. |
Cluster III
Cluster IiI is randomized to start the VIPP-PUF intervention phase March 1, 2023
|
Behavioral: VIPP-PUF
The VIPP-PUF Intervention is developed as an add-on to the existing PUF-program to address infants with major cognitive and regulatory vulnerabilities identified at age 9-10 months and adapted to the settings of community health nurses. The intervention (VIPP-PUF) will be created from an evidence-based method, the Video-based Intervention to Promote Positive Parenting (VIPP), to comprise six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The VIPP -PUF builds on teaching the health nurses to promote parents' sensitivity to meet infants' cognitive and regulatory vulnerabilities, while taking in account the particular needs of families of psycho-social disadvantage. |
- Child mental health [ Time Frame: child age 24 months ]
The Strengths and Difficulties Questionnaire (SDQ) answered by parents is used at ages 24 months in order to use this very short (25-items) and feasible measure both at age 24 months and at the planned follow-up at older ages.
SDQ is highly predictive of persistent child mental health problems and suitable for the prospective investigation of mental health from ages 24 months and onwards. SDQ has been validated for use in children down to the age of 2 years, and used in epidemiological research worldwide, also in Danish populations, with Danish norms being available.
- Social and emotional development [ Time Frame: Child age 24 months ]The Ages and Stages Questionnaire, Social-Emotional 2 (ASQ: SE2) (version for children aged 1 to 60 months) is used to measure the child's self regulation, compliance, communication and adaptive functioning. It comprises 19 to 33 items rated by parents and includes a box parents in which parents may check if the behavior is a concern for them. The ASQ:SE2 is well-validated and the most commonly used measure of young children's social and emotional development, internationally as well as in Denmark.
- Weight-for-length z-scores [ Time Frame: child age 24 months ]Weight-for-length z-scores are calculated from weight and lengths measured by CHNs at home visits using transportable scales and height carts and guidelines on how to perform the measurements.
- Parenting [ Time Frame: Child age 24 months ]The Being a Mother (BaM13)
- Parental Stress [ Time Frame: Child age 24 months ]The Parental Stress Scale (PSS). The scale is rated from 1-5 and values are summarised to a total PSS with some scores coded in the reverse order when relevant, with low total PSS scores being a better outcome.
- Family impairment [ Time Frame: Child age 24 months ]The WHO-5 well-being index (WHO-5)
- Sensitive parenting [ Time Frame: Child age 24 months ]
Sensitive parenting will be examined from observer-ratings of video-recording of parent-infant interaction using the Child Interaction Behavior (CIB) system to assess the parent-child relationship. The CIB system contains 22 parent behavior codes, 16 child behavior codes, and five dyadic codes which can be aggregated into the following composites: sensitivity, intrusiveness, limit setting, involvement, withdrawal, compliance, dyadic reciprocity, and dyadic negative states. The CIB system has been validated in normative as well as high-risk populations, and shows stability over time, predictive validity and adequate psychometric properties.
Coders will be trained to optimize intercoder reliability; and regular meetings and checks will be organized to prevent coder drift.
- Eating behaviour and sensitive parenting during meals [ Time Frame: Child age 24 months ]Video-recordings of mealtimes are used to examine the child's eating behaviour, the parents feeding behaviour, and the parent-child interaction with regard to parental sensitivity, intrusiveness and limit setting, regarding the child' involvement, withdrawal and compliance and concerning the overall dyadic reciprocity during a meal.
- Parental feeding questionnaire [ Time Frame: Child ages 18 and 24 months ]the Preschooler Feeding Questionnaire (PFQ) and the Child Feeding Questionnaire (CFQ) will be used to assess parent's perception of their feeding practices.
- Child eating questionnaire [ Time Frame: Child age 24 months ]The Child Eating Behavior Questionnaire (CEBQ) will be used to measure parent's perceptions of their child's eating behavior.
- Child development progress [ Time Frame: Child age 24 months ]The Ages and Stages Questionnaire, Third Edition (ASQ-3) consists of the following subscales: communication, gross motor, fine motor, problem-solving, and personal-social.
- Social and emotional development [ Time Frame: Child at age 18 months ]The Ages and Stages Questionnaire, Social-Emotional 2 (ASQ: SE2) (version for children aged 1 to 60 months) is used to measure the child's self-regulation, compliance, communication and adaptive functioning. It comprises 19 to 33 items rated by parents and includes a box parents in which parents may check if the behavior is a concern for them. The ASQ SE2 is well-validated and the most commonly used measure of young children's social and emotional development, internationally as well as in Denmark.
- Parenting [ Time Frame: Child at age 18 months ]The Being a Mother (BaM 13)
- Parental Stress [ Time Frame: Child at age 18 months ]The Parental Stress Scale (PSS). The scale is rated from 1-5 and values are summarised to a total PSS with some scores coded in the reverse order when relevant, with low total PSS scores being a better outcome.
- Family impairment [ Time Frame: Child at age 18 months ]The WHO-5 well-being index (WHO-5)
- Sensitive parenting [ Time Frame: Child age 18 months ]
Sensitive parenting will be examined from observer-ratings of video-recording of parent-infant interaction using the Child Interaction Behavior (CIB) system to assess the parent-child relationship. The CIB system contains 22 parent behavior codes, 16 child behavior codes, and five dyadic codes which can be aggregated into the following composites: sensitivity, intrusiveness, limit setting, involvement, withdrawal, compliance, dyadic reciprocity, and dyadic negative states. The CIB system has been validated in normative as well as high-risk populations, and shows stability over time, predictive validity and adequate psychometric properties.
Coders will be trained to intercoder reliability ICC > .65, Pearson's r > .70, and regular meetings and checks will be organized to prevent coder drift.
- Eating behavior incl overeating [ Time Frame: Child age 18 months ]Parents answers questions on eating behaviour as part of the CBCL version 1 ½ -5.
- Regulatory problems [ Time Frame: Child age 18 months ]The Child Behaviour Checklist (CBCL) version for children aged 1 ½ -5 years, which includes information on regulatory problems of eating, sleep, emotions, behavioural and cognitive functions.
- Parenting [ Time Frame: Child age 18 months ]The Mother and Baby Interaction Scale (MABISC). The scale is rated from 0-4 and values are summarised to a total MABISC with some scores coded in the reverse order when relevant, with low total MABISC scores being a better outcome.
- Body composition (bioimpedance) [ Time Frame: Child age 24 months ]Body composition will be measured using bioimpedance which is feasible for use for children aged 24 months at a home visit. We will measure bioimpedance using the Impedimed SFB7 device (Impedimed, Brisbane, Australia) among 50 recruited children to calculate fat mass (FM) and fat-free mass (FFM). Based on previous literature on young children, we will use reference values for body composition for children to identify excess adiposity.
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Ages Eligible for Study: | 9 Months to 11 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Three or more PUF problems at the PUF
Exclusion Criteria:
- Severe mental or physical illness or handicap.
- Not Danish or English speaking parents
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601779
Denmark | |
National Institute of Public Health | |
Copenhagen, Denmark |
Principal Investigator: | Anne Mette Skovgaard, MD DM SCI | Professor | |
Study Director: | Morten Hulvej Rod, PhD | Head of the National Institut of Public Health |
Documents provided by University of Southern Denmark:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Southern Denmark |
ClinicalTrials.gov Identifier: | NCT04601779 |
Other Study ID Numbers: |
95-110-21307 |
First Posted: | October 26, 2020 Key Record Dates |
Last Update Posted: | December 6, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infant mental health Regulatory problems Developmental psychopathology |
Video-feedback to Promote Positive Parenting, VIPP Overeating in infancy Infancy overweight |
Hypersensitivity Immune System Diseases |