NCT07656272

Brief Summary

This study aims to evaluate the effectiveness of an online video-based developmental support program for parents of children aged 1-3 years receiving care at a Family Health Center. Approximately 60 parents will be randomly assigned to either an intervention group, which will receive a four-week online developmental support program, or a control group, which will continue to receive usual healthcare services. Data will be collected at baseline, two weeks after the intervention, and at one- and three-month follow-up assessments. The study will examine the effects of the online video-based developmental support program on parents' attitudes toward child development, developmental awareness, parenting self-efficacy, and the quality of the home environment that supports child development.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 10, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

Developmental Support ProgramSelf-Efficacy in Parenting TasksMindful Awareness in ParentingParents' Attitudes Towards Psychosocial DevelopmentStimulating Home Environment

Outcome Measures

Primary Outcomes (4)

  • 0-6 Years Psychosocial Developmental Attitudes Scale

    Total score of the 0-6 Years Psychosocial Developmental Attitudes Scale assessing parents' attitudes toward psychosocial development in early childhood. The scale consists of 18 items rated on a 3-point Likert scale (1 = Disagree, 2 = Sometimes, 3 = Agree). The total score ranges from 18 to 54, with higher scores indicating a more positive and appropriate attitude toward supporting the psychosocial development of children aged 0-6 years. Higher scores reflect more accurate and supportive parental attitudes toward child psychosocial development, while lower scores indicate less positive or less appropriate attitudes.

    From enrollment to 3 months after completion of the intervention

  • Interpersonal Mindfulness in Parenting Questionnaire

    The Interpersonal Mindfulness in Parenting Questionnaire (MIPQ) is a 24-item scale designed to assess parents' mindfulness in interactions with their children. It consists of two subscales: Being in the Moment with the Child (11 items) and Mindful Discipline (13 items). Items are rated on a 4-point Likert scale ranging from 1 (rarely) to 4 (almost always). The total score ranges from 24 to 96. Higher scores indicate higher levels of mindful parenting, reflecting greater awareness, emotional regulation, and present-moment attention in parent-child interactions. Lower scores indicate lower mindfulness in parenting behaviors. The scale has no reverse-coded items. Reported internal consistency reliability is 0.87 for the total scale, 0.73 for the Being in the Moment subscale, and 0.83 for the Mindful Discipline subscale.

    From enrollment to the end of the 3-month follow-up period after the interventio

  • Parenting Self-Efficacy Scale

    The Parenting Self-Efficacy Scale (Short Form) is a questionnaire designed to assess parents' perceived self-efficacy in performing parenting tasks. The original scale was developed by Emde in 1989 and revised by Zeanah in 1997. The short form was developed by Van Rijen in 2014 and the Turkish validity and reliability study was conducted by Özkan Kunduracı and Aksoy in 2021. The scale consists of four subscales: care and involvement, discipline, play, and routines. It includes items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score reflects the level of parenting self-efficacy, with higher scores indicating higher perceived competence and confidence in parenting roles, while lower scores indicate lower self-efficacy. The reported internal consistency reliability (Cronbach's alpha) is 0.88.

    From enrollment to the end of the 3-month follow-up period after the intervention

  • Infant-Toddler Home Observation for Measurement of the Environment (IT-HOME) Inventory

    The Infant-Toddler Home Observation for Measurement of the Environment (IT-HOME) Inventory is used to assess the quality of the home environment that supports child development in infants and toddlers aged 3-36 months. The original scale was developed by Bradley and Caldwell in 1965 and updated by the National Institute of Child Health and Human Development (NICHD) in 2003. The Turkish validity and reliability study was conducted by Fındık and Aral in 2023. The scale consists of 45 items across six subscales: responsivity (11 items), acceptance (8 items), organization (6 items), learning materials (9 items), involvement (6 items), and variety (5 items). Each item is scored dichotomously as Yes or No. The total score ranges from 0 to 45, with higher scores indicating a higher quality home environment that is more supportive of child development. Lower scores indicate a less stimulating and less supportive home environment. The scale is administered through observation and/or intervi

    From enrollment to the end of the 3-month follow-up period after the intervention

Study Arms (2)

Salutogenic Model-Based Developmental Support Program

EXPERIMENTAL

Parents in the experimental group will receive a 4-week video-based developmental support program delivered via Zoom. The program is based on the salutogenic model (comprehensibility, manageability, and meaningfulness) and aims to improve parental understanding of child development, parenting self-efficacy, and mindful parenting skills. The intervention consists of four weekly sessions delivered in groups of 15 participants, each lasting 30-45 minutes.

Other: Developmental support program based on the salutogenic model

Routine Care

NO INTERVENTION

Parents in the control group will continue to receive routine primary healthcare services provided at Family Health Centers, including standard child health monitoring, vaccinations, and counseling services. No additional educational or interventional program will be provided during the study period.

Interventions

A 4-week video-based developmental support program delivered via Zoom for parents of children aged 12-36 months. The program is based on the salutogenic model (comprehensibility, manageability, meaningfulness). It includes four weekly group sessions (15 participants per group), each lasting 30-45 minutes. The program aims to improve parental understanding of child development and parenting skills.

Salutogenic Model-Based Developmental Support Program

Eligibility Criteria

Age15 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipation is limited to female participants who are mothers of children aged 12-36 months.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with children aged 12-36 months
  • Children with a percentile value between the 3rd and 97th percentile
  • Able to speak and understand Turkish
  • No previous participation in a similar program
  • Having internet access and the ability to use a computer/laptop, tablet, or smartphone
  • At least primary school graduates
  • Able to read and comprehend written information
  • Willing to participate in the study

You may not qualify if:

  • Adolescent parents
  • Parents of children with congenital anomalies, chronic diseases, or a history of prematurity
  • Individuals with a diagnosed mental health disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Pınar Ateş, Registered Nurse

CONTACT

Yağmur Sezer Efe, Assoc. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The intervention applied in this study is a salutogenic model-based developmental support program developed for parents of children aged 12-36 months attending Family Health Centers. The intervention is structured based on the core components of the salutogenic approach: comprehensibility, manageability, and meaningfulness. The program is designed to help parents better understand child development, make developmental processes more manageable, and support them in perceiving their parenting role as a more meaningful life experience.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, Registered Nurse (RN)

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 18, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared in order to protect participant confidentiality and ensure privacy. All collected data will be anonymized and reported only in aggregate form. Individual-level data sharing is not planned due to ethical and data protection considerations.