Development and HealthNCT07656272
Developmental Support Program: A Intervention Study
A study testing Developmental support program based on the salutogenic model in people with Development and Health, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Development and Health
- What is being tested?
- Developmental support program based on the salutogenic model
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adolescent parents
- Parents of children with congenital anomalies, chronic diseases, or a history of prematurity
- Individuals with a diagnosed mental health disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Development and Health
- Being tested
- Developmental support program based on the salutogenic model
- Keywords
- Developmental Support Program, Self-Efficacy in Parenting Tasks, Mindful Awareness in Parenting, Parents' Attitudes Towards Psychosocial Development, Stimulating Home Environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental support program based on the salutogenic modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From enrollment to the end of the 3-month follow-up period after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development and HealthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Ateş, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656272
- Sponsor's protocol ID
- ErciyesU-SBF-PA-01
- Other IDs
- Assoc. Prof. Dr. Yağmur Sezer
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Developmental Support Program for Parents of Children Aged 1-3 Years in a Family Health Center: An Interventional Study
- ClinicalTrials.gov ID
- NCT07656272
- Acronym / sponsor ID
- ErciyesU-SBF-PA-01
- Conditions
- Development and Health
- Keywords
- Developmental Support Program, Self-Efficacy in Parenting Tasks, Mindful Awareness in Parenting, Parents' Attitudes Towards Psychosocial Development, Stimulating Home Environment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Salutogenic Model-Based Developmental Support Program | Experimental | Other: Developmental support program based on the salutogenic modelParents 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. |
| 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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Adolescent parents
- Parents of children with congenital anomalies, chronic diseases, or a history of prematurity
- Individuals with a diagnosed mental health disorder
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 |
|---|---|---|
| Developmental support program based on the salutogenic modelA 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. | Other | Salutogenic Model-Based Developmental Support Program |
Primary outcome
0-6 Years Psychosocial Developmental Attitudes Scale
Time frame: From enrollment to 3 months after completion of the intervention
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.
Interpersonal Mindfulness in Parenting Questionnaire
Time frame: From enrollment to the end of the 3-month follow-up period after the interventio
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.
Parenting Self-Efficacy Scale
Time frame: From enrollment to the end of the 3-month follow-up period after the intervention
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.
Infant-Toddler Home Observation for Measurement of the Environment (IT-HOME) Inventory
Time frame: From enrollment to the end of the 3-month follow-up period after the intervention
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Developmental support program based on the salutogenic model in people with Development and Health, run by TC Erciyes University.
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 8 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pınar Ateş, Registered Nurse (+90 507 786 81 91, pinarates505@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0-6 Years Psychosocial Developmental Attitudes Scale (time frame: From enrollment to 3 months after completion of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.