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Child development, parenting and primary health care program

Child development, parenting and primary health care - "Crescer em Grande!" program (CeG Program): a cluster randomised trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN90692907
Enrollment
264
Registered
2020-02-08
Start date
2022-11-01
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenting abilities Not Applicable

Interventions

Intervention and Control The CeG intervention will consist of two components: 1) the integration of the TP approach in PC maternal and well-child visits, with the support of 28 leaflet

Sponsors

CINTESIS – Center for Health Technology and Services Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Primary Care Providers: Family physicians and family nurses from each site will be recruited if they maintain a regular clinical practice in maternal and child health visits in the PC unit 2. Parents: 2.1. Have a confirmed pregnancy 2.2. Do maternal surveillance with the family doctor and wish to maintain pediatric surveillance of their baby in the PC unit 2.3 Are at least 18 years old 2.4. Are fluent in Portuguese as judged by the consenting provider 2.5. Are able to understand all aspects of the study and provide informed consent 3. Baby/child: children of the participating parents that are born during the study

Exclusion criteria

Exclusion criteria: PC providers: 1. Within each clinic, maternal and pediatric health care delivered during the study may not be provided by any person without relevant training (e.g., a first-year family physician resident, trainee nurse) 2. PC providers will be ineligible if they are planning to retire during the study period or abandon the unit for another reason. Parents: 1. Wish to do concomitant regular pediatric surveillance at another health unit (public or private) not motivated by the need for disease surveillance in secondary health care (e.g., hospital follow-up for cardiac disease treated by a pediatric cardiologist) 2. Intend to relocate during the study period

Design outcomes

Primary

MeasureTime frame
For Parents: Parenting sense of competence using the Parenting Sense of Competence Scale (PSOC) at baseline and 18-months

Secondary

MeasureTime frame
For parents: 1. Family dynamics (Family Environment Scale – FES) 2. Couple dynamics (Revised Dyadic Adjustment Scale - RDAS) 3. Mental health including depression/anxiety and stress (Depression, Anxiety and Stress Scale-21 - DASS-21; Parental Stress Inventory – PSI) 4. Well-being/quality of life (EUROHIS-QOL-8 - QOL) 5. Psychological experience of pregnancy (Pregnancy and Motherhood Attitudes Scale - PMAS) 6. Maternal/paternal attachment (Antenatal Attachment Scale – AAS; Postnatal Attachment Scale – PAS) For the Child: 1. Child development (Baby form; Child form; Child Behavior Checklist - CBCL, 1,5-5 - parent version) For PC Providers: 1. Effect of the training period namely on providers’ knowledge on TP model, self-efficacy and intention to use it to better support children and families (PKQ). About the intervention CeG: 1. Acceptability, satisfaction and feasibility associated with delivering the CeG intervention arm with respect to usual care (Satisfaction Questionnaire – SQ; PC providers/parents version) 2. Evaluation of costs associated with delivering the CeG Assessment timepoints: First contact with parents in primary care unit, after the study start: Sociodemographic questionnaire; RDAS; QOL 26-29 weeks of pregnancy: DASS-21 30-32 weeks of pregnancy: PMAS; AAS 33-35 weeks of pregnancy: FES 36-40 weeks of pregnancy: RDAS; QOL Newborn: Baby Form (data collected by PC provider) 1st Month: PSOC; PSI 2nd Month: DASS-21 4th Month: - 6th Month: FES; PAS 9th Month: PSOC; PSI 12th Month: - 15th Month: DASS-21; RDAS; QOL

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026