Developmental Support Program: A Intervention Study

The Effect of a Developmental Support Program for Parents of Children Aged 1-3 Years in a Family Health Center: An Interventional Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Development and Health
• Intervention / Treatment: Other: Developmental support program based on the salutogenic model

Detailed Description

Study Design This study is a randomized controlled, parallel-group experimental trial with pre-test and post-test measurements.

Study Setting The study will be conducted at Şeyh Şamil Family Health Center, one of the Family Health Centers affiliated with the Sivas Provincial Health Directorate. The center was selected because it serves the highest number of children aged 12-36 months among the eligible centers. Child development is monitored according to the Infant, Child, and Adolescent Follow-up Protocol of the General Directorate of Public Health. Nurses provide developmental screening, immunization, anthropometric measurements, risk assessment, early intervention activities, and parental counseling services.

Population and Sample The study population consists of 310 parents with children aged 12-36 months. The sample size was calculated using G*Power version 3.1.9.4 software. Based on Cohen's criteria, a medium effect size (Cohen's d = 0.5), a 95% confidence level (α = 0.05), and 80% statistical power (1 - β = 0.80) were used. Accordingly, a minimum of 30 participants per group (total sample size = 60) was required for an independent samples t-test design. Considering a potential attrition rate of 20%, the final sample size was determined as 60 participants. Participants will be randomly assigned to either the intervention group (n = 30) or the control group (n = 30).

Eligibility Criteria Inclusion Criteria

• Being the parent of a child aged 12-36 months
• Child's growth percentile being between the 3rd and 97th percentiles
• Ability to speak and understand Turkish
• No prior participation in a similar developmental support program
• Having internet access and the ability to use a computer, tablet, or smartphone
• Completion of at least primary school education
• Ability to read and understand written materials
• Willingness to participate in the study Exclusion Criteria
• Missing at least one session of the intervention program
• Living in an extended family household
• Experiencing a major psychosocial event within the last six months (e.g., relocation, death of a first-degree relative, or divorce)
• Adolescent parenthood
• Having a child with a history of congenital anomalies, chronic illness, or prematurity
• Having a diagnosed mental health disorder Blinding Due to the nature of the intervention, participants and researchers cannot be blinded. However, statistical and reporting blinding will be implemented. Data will be coded without indicating group allocation, and statistical analyses will be conducted by an independent statistician.

Randomization Participants who meet the eligibility criteria will be assigned to either the intervention or control group using a simple randomization procedure conducted through an online randomization program.

Outcome Measures Primary Outcomes

• Score on the Psychosocial Developmental Attitudes Scale for Ages 0-6
• Score on the Mindful Parenting Scale
• Score on the Parenting Self-Efficacy Scale
• Score on the Home Observation and Measurement of the Environment Scale for Young Children Data Collection Instruments Data will be collected using the Family Information Form, the Psychosocial Developmental Attitudes Scale for Ages 0-6, the Mindful Parenting Scale, the Parenting Self-Efficacy Scale (Short Form), and the Home Observation and Measurement of the Environment Scale for Young Children.

Intervention Development The developmental support program will be developed based on a literature review and expert consultation. Content validity will be evaluated by experts in child development and pediatric nursing using the Davis technique. Each item will be rated on a four-point scale. A Content Validity Index (CVI) greater than 0.80 will be considered acceptable. The final program will consist of four modules, each containing two sessions. A pilot study involving five parents who are not included in the main study will be conducted to assess the feasibility of the intervention and the clarity of the data collection instruments. Revisions will be made based on participant feedback.

Intervention Procedures Participants in the intervention group will complete baseline assessments before receiving the developmental support program. The intervention will be delivered online over four weeks through video-supported sessions conducted via Zoom. Participants will attend one session per week in groups of approximately 15 parents. Each session will last 30-45 minutes. Process evaluation forms will be used to assess participation and satisfaction. Outcome measures will be repeated two weeks after program completion and at one-month and three-month follow-up assessments.

Control Group Participants in the control group will continue to receive routine primary healthcare services provided by the Family Health Center. Assessments will be conducted at the same time points as in the intervention group. After completion of the study, the developmental support program videos will be made available to participants in the control group.

Data Collection Methods Data will be collected through face-to-face interviews conducted either at the Family Health Center or in participants' homes. Written informed consent will be obtained before participation. Baseline, post-intervention, and follow-up assessments will be completed using standardized measurement instruments.

Data Analysis Data will be analyzed using IBM SPSS Statistics (Statistical Package for the Social Sciences). The normality of data distribution will be assessed using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. For normally distributed data, independent samples t-tests and analysis of variance (ANOVA) will be used. For non-normally distributed data, the Mann-Whitney U test and Kruskal-Wallis test will be applied. Relationships between variables will be examined using Pearson correlation analysis or Spearman rank correlation analysis. Statistical significance will be defined as a p-value less than 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pınar Ateş, Registered Nurse; Phone Number: +90 507 786 81 91; Email: pinarates505@gmail.com
• Study Contact Backup: Name: Yağmur Sezer Efe, Assoc. Prof. Dr.; Phone Number: +90 0507 437 85 62; Email: ysezerefe@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salutogenic Model-Based Developmental Support Program; 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; 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.
No Intervention: Routine Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Developmental Support Program; Self-Efficacy in Parenting Tasks; Mindful Awareness in Parenting; Parents' Attitudes Towards Psychosocial Development; Stimulating Home Environment
• Other Study ID Numbers: ErciyesU-SBF-PA-01; Assoc. Prof. Dr. Yağmur Sezer (Other Identifier: Erciyes University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No