Behavior, InfantNCT03367845
Efficacy of Family Programs for Improving Child and Family Health and Development
A study testing Sensitivity Intervention, Couples' Intervention and Sensitivity and Couples' Intervention in people with Behavior, Infant, run by Colorado State University at 2 sites in United States.
Trial summary
The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Infant
- What is being tested?
- Sensitivity Intervention, Couples' Intervention and Sensitivity and Couples' Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2017to 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents cohabiting
- Both mothers and fathers agree to participate
- Healthy infants with no known health problems
Who cannot join
- Discovery of developmental delays or health problems in infants
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fort Wayne Center for Children and Families
Fort Wayne, Indiana, 46814
William J. Shaw Center for Children and Families
South Bend, Indiana, 46535
About this study
The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available family-wide programs that can promote healthy development that best serve infants, mothers, fathers, and inter-parental relationships in cost-effective ways. This study also systematically tests for which families the interventions are most effective and rigorously tests the theoretical processes that link changes in mother-infant, father-infant, and mother-father interactions with infant and parent outcomes.
Read the detailed description
Preventative interventions involving video-feedback programs to promote parenting (VIPP) have been shown to be successful in improving maternal sensitivity and infant-mother attachment security. However, interventions might be substantially more effective if broader elements of family systems were also addressed, including father-child and inter-parental relationships, particularly given the growing body of evidence that highlights the importance of father involvement and positive engagement in children's socio-emotional development. Infancy is a particularly sensitive and vulnerable period not only for the child but also for the parents who often experience heightened daily stress, parenting demands, work-family role strain, and inter-parental discord associated with changes in the family.The proposed longitudinal study addresses major gaps by testing the effectiveness of family-wide preventative interventions designed to promote healthy development and functioning in infants, mothers, and fathers, including low-income families. This three-phase study involves a rigorous randomized clinical trial (RCT) approach and will involve a demographically diverse sample of 400 families. Phase I involves a lab and home pre-test (infants 6 months of age) and 8-week intervention period; Phase II (12 months) includes an initial post-test, and Phase III (16-18 months) involves a second post-test. Families will be randomly assigned to one of four conditions: sensitivity intervention (SI), couples intervention (CI), both (SI + CI) or control. Specific aims of the study include: (1) An evaluation of the effectiveness of the SI, CI, and SI+CI interventions at improving parental sensitivity, parental efficacy, parenting stress, inter-parental conflict, infant affective development, attachment security, behavior problems, and socio-emotional competence; (2) A test of the mechanisms through which change in behavior occurs. For example, relations between SI participation in Phase I and child attachment in Phase III may be mediated by enhanced parent sensitivity in Phase II.
Relations between CI participation and child outcomes may be mediated by inter-parental functioning and more effective communication skills; (3) An examination of factors that moderate the effectiveness of the interventions, determining which families benefit the most. Potential moderators include demographic characteristics, family (dis)organization, parents' own caregiving history, parents' depressive and anxious systems, and infant negative temperament; (4) Mother-father comparisons on direct effects, mediating mechanisms and moderating processes. This study builds upon past research towards increasing children's emotional security in multiple family relationships by testing new directions in preventative interventions in infancy, addressing the mother-child, father-child, and mother-father relationships. The goal is to foster children's socio-emotional development and security through cost-effective family-wide interventions in infancy that promote sensitive parent-infant interactions and improved inter-parental communication.
- Conditions
- Behavior, Infant
- Being tested
- Control, Sensitivity Intervention, Couples' Intervention, Sensitivity and Couples' Intervention
- Keywords
- Parent sensitivity, Fathers, Attachment, Marital communication
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Parents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention.
Sensitivity InterventionBehavioural
Also called Videofeedback to Promote Positive Parenting
4 home visits take place. Mothers and fathers are video recorded with their infant (separately) for approximate 10-15 minutes at the beginning of each visit. The recorded situations are natural (e.g., playing together, bathing the baby, mealtime, etc.) and the family coach (interventionist) is not actively involved in the parent-child interaction. A different theme is covered across the four intervention sessions. For each parent-infant interaction recording, the family coach reviews the recordings between visits and provides feedback to parents in the following intervention session. The exception to this is that video of parent-child interactions during the lab pre-test is used for material at the first home visit. Each session takes approximately 90 minutes. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.
Couples' InterventionBehavioural
The psycho-educational inter-parental conflict prevention curriculum is a 4-session program that takes place in the families' homes. Each session lasts approximately 90 minutes and involves discussion and practice of four themes pertinent to improving conflict process, communication, and emotional security in the family: Conflict Overview, Interparental Conflict and Children, Stresses of Parenting, and Emotional Security. The family coach scaffolds and supports the couples' development of constructive conflict behaviors. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.
Sensitivity and Couples' InterventionBehavioural
This group receives both the Sensitivity and Couples' Intervention in their home. There are 8 home visits (4 for Sensitivity and 4 for Couples Intervention). Because of COVID-19, we now conduct remote visits using Zoom.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Phone contacts with content not focusing on sensitivity or couples' relationships Receives: Behavioral: Control |
| Sensitivity Intervention | Experimental | Home visits to enhance mother-infant and father-infant parental sensitivity; with COVID-19, we now conduct remote visits using Zoom Receives: Behavioral: Sensitivity Intervention |
| Couples Intervention | Experimental | Home visits to enhance constructive couples' communication; with COVID-19, we now conduct remote visits using Zoom Receives: Behavioral: Couples' Intervention |
| Sensitivity and Couples Intervention | Experimental | Home visits combining sensitivity and couples' interventions; with COVID-19, we now conduct remote visits using Zoom Receives: Behavioral: Sensitivity and Couples' Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parental Sensitivity
Observational measure of parent sensitivity during infant-parent interactions
Measured: 12-months
Change in Child Care Activities Scale
Parent-report questionnaire assessing degree of involvement with infants at home, reflecting percent time engaging in each activity. Subscales include: Direct Care, Indirect Care, Play Activities, and Total score all ranging from 0 - 100. Higher values mean higher percentage of time spent in that caretaking activity. Scores are averaged to create the subscales and total score.
Measured: 12-months
Change in Parenting Stress Index - Short Form Version III
Parent-report questionnaire assessing degree of stress about roles as a parent. Subscales include: Parental Distress (scale range from 5 - 60; 33 and higher = 85th percentile); Parent-Child Dysfunctional Interaction (scale range 5 - 60; 26 and higher = 85th percentile); Difficult Child (scale range 5 - 60; 33 and higher = 85th percentile); Total Score (scale range 15 - 180; 86 and higher = 85th percentile). Higher values mean greater levels of parenting stress. Scores are summed to create subscales and the total score.
Measured: 12 months
Change in Parenting Sense of Competence Scale
Parent-report measure of self-efficacy in their role as a parent. Subscales include Satisfaction (cale range 9 - 54); Efficacy (scale range 8 - 48). Total Score (scale range 17 - 102). Higher values indicate a greater satisfaction, efficacy, and total sense of competence. Scores are summed to create the subscales and total score.
Measured: 12-months
Change in Spousal Attachment Questionnaire
Parent report questionnaire assessing parents' security in their relationships with each other. Subscales include Preoccupied Attachment (scale range 1 - 7); Fearful Attachment (scale range 1 - 7); Secure Attachment (scale range 1 - 7). Higher values mean greater levels of that type of attachment to spouse. Scores are averages of item sets.
Measured: 12-months
Change in Conflict and Problem Solving Scale
Parent report questionnaire assessing conflict strategies in spousal relationship. Subscales include Cooperation (scale range 0 - 36); Avoidance and Capitulation (scale range 0 - 60); Stonewalling (scale range 0 - 42); Verbal Aggression (scale range 0 - 48); Physical Aggression (scale range 0 - 42); Child Involvement (scale range 0 - 30); Conflict Resolution (scale range 0 - 39). Higher scores indicate greater levels of use of conflict strategies or greater resolution. Item sets are summed to create subscale scores.
Measured: 12-months
Change in O'Leary Porter Scale
Parent report questionnaire assessing children's exposure to marital conflict. There is a total score (scale range 0 - 36). Higher values indicate more conflict. Items are summed to create the total score.
Measured: 12-months
Change in Brief Infant Toddler Emotional Assessment
Parent questionnaire evaluating children's behavior problems and competence. Subscales include Problems (scale range 0 - 66); Competencies (scale range 0 - 22); Externalizing problems (scale range 0 - 12); Internalizing (scale range 0 - 16); Dysregulation (scale range 0 - 16); Autism Spectrum Disorder (scale range 0 - 17). Higher scores indicate higher levels of each construct or higher screening value for Autism Spectrum Disorder. Scores are summed.
Measured: 12-months
Mother-Infant Attachment
Observational ratings of infant attachment security with mothers from the Strange Situation; with COVID-19, we no longer do in-person assessments so we now use a modified version of the Attachment Q-Sort which is an interview with mothers over zoom.
Measured: 12 months
Father-Infant Attachment
Observational ratings of infant attachment security with fathers from the Strange Situation; with COVID-19, we no longer do in-person assessments so we now use a modified version of the Attachment Q-Sort which is an interview with fathers over zoom.
Measured: 10 months
Change in Couples' communication styles
Observational measure of parents' conflict styles during discussions
Measured: 12-months
Change in Infant Affect Regulation
Observational measure of infants' affective and regulatory behaviors during parent-child interactions and during couples' discussions
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start11 Jan 2017
- Primary completion30 Jan 2023
- 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 Behavior, InfantStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 X 2 factorial design testing two different interventions
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Samantha Murray-Perdue, Colorado State University
- Investigators
- Samantha Murray-Perdue, Ph.D., Principal investigator, Colorado State UniversityE M Cummings, Ph.D., Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367845
- Sponsor's protocol ID
- 4152
- Other IDs
- R01HD087319
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2017
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the close of the study, subject data will be deidentified and individual participant data will no longer be available for further use.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Family Programs for Improving Child and Family Health and Development
- ClinicalTrials.gov ID
- NCT03367845
- Acronym / sponsor ID
- 4152
- Conditions
- Behavior, Infant
- Keywords
- Parent sensitivity, Fathers, Attachment, Marital communication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Dec 2017 (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.
The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available family-wide programs that can promote healthy development that best serve infants, mothers, fathers, and inter-parental relationships in cost-effective ways. This study also systematically tests for which families the interventions are most effective and rigorously tests the theoretical processes that link changes in mother-infant, father-infant, and mother-father interactions with infant and parent outcomes.
Detailed description
Preventative interventions involving video-feedback programs to promote parenting (VIPP) have been shown to be successful in improving maternal sensitivity and infant-mother attachment security. However, interventions might be substantially more effective if broader elements of family systems were also addressed, including father-child and inter-parental relationships, particularly given the growing body of evidence that highlights the importance of father involvement and positive engagement in children's socio-emotional development. Infancy is a particularly sensitive and vulnerable period not only for the child but also for the parents who often experience heightened daily stress, parenting demands, work-family role strain, and inter-parental discord associated with changes in the family.The proposed longitudinal study addresses major gaps by testing the effectiveness of family-wide preventative interventions designed to promote healthy development and functioning in infants, mothers, and fathers, including low-income families. This three-phase study involves a rigorous randomized clinical trial (RCT) approach and will involve a demographically diverse sample of 400 families. Phase I involves a lab and home pre-test (infants 6 months of age) and 8-week intervention period; Phase II (12 months) includes an initial post-test, and Phase III (16-18 months) involves a second post-test. Families will be randomly assigned to one of four conditions: sensitivity intervention (SI), couples intervention (CI), both (SI + CI) or control. Specific aims of the study include: (1) An evaluation of the effectiveness of the SI, CI, and SI+CI interventions at improving parental sensitivity, parental efficacy, parenting stress, inter-parental conflict, infant affective development, attachment security, behavior problems, and socio-emotional competence; (2) A test of the mechanisms through which change in behavior occurs. For example, relations between SI participation in Phase I and child attachment in Phase III may be mediated by enhanced parent sensitivity in Phase II.
Relations between CI participation and child outcomes may be mediated by inter-parental functioning and more effective communication skills; (3) An examination of factors that moderate the effectiveness of the interventions, determining which families benefit the most. Potential moderators include demographic characteristics, family (dis)organization, parents' own caregiving history, parents' depressive and anxious systems, and infant negative temperament; (4) Mother-father comparisons on direct effects, mediating mechanisms and moderating processes. This study builds upon past research towards increasing children's emotional security in multiple family relationships by testing new directions in preventative interventions in infancy, addressing the mother-child, father-child, and mother-father relationships. The goal is to foster children's socio-emotional development and security through cost-effective family-wide interventions in infancy that promote sensitive parent-infant interactions and improved inter-parental communication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 X 2 factorial design testing two different interventions
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: ControlPhone contacts with content not focusing on sensitivity or couples' relationships |
| Sensitivity Intervention | Experimental | Behavioral: Sensitivity InterventionHome visits to enhance mother-infant and father-infant parental sensitivity; with COVID-19, we now conduct remote visits using Zoom |
| Couples Intervention | Experimental | Behavioral: Couples' InterventionHome visits to enhance constructive couples' communication; with COVID-19, we now conduct remote visits using Zoom |
| Sensitivity and Couples Intervention | Experimental | Behavioral: Sensitivity and Couples' InterventionHome visits combining sensitivity and couples' interventions; with COVID-19, we now conduct remote visits using Zoom |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents cohabiting
- Both mothers and fathers agree to participate
- Healthy infants with no known health problems
Key exclusion criteria (1 listed)
- Discovery of developmental delays or health problems in infants
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 |
|---|---|---|
| ControlParents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention. | Behavioural | Control |
| Sensitivity InterventionAlso: Videofeedback to Promote Positive Parenting4 home visits take place. Mothers and fathers are video recorded with their infant (separately) for approximate 10-15 minutes at the beginning of each visit. The recorded situations are natural (e.g., playing together, bathing the baby, mealtime, etc.) and the family coach (interventionist) is not actively involved in the parent-child interaction. A different theme is covered across the four intervention sessions. For each parent-infant interaction recording, the family coach reviews the recordings between visits and provides feedback to parents in the following intervention session. The exception to this is that video of parent-child interactions during the lab pre-test is used for material at the first home visit. Each session takes approximately 90 minutes. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom. | Behavioural | Sensitivity Intervention |
| Couples' InterventionThe psycho-educational inter-parental conflict prevention curriculum is a 4-session program that takes place in the families' homes. Each session lasts approximately 90 minutes and involves discussion and practice of four themes pertinent to improving conflict process, communication, and emotional security in the family: Conflict Overview, Interparental Conflict and Children, Stresses of Parenting, and Emotional Security. The family coach scaffolds and supports the couples' development of constructive conflict behaviors. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom. | Behavioural | Couples Intervention |
| Sensitivity and Couples' InterventionThis group receives both the Sensitivity and Couples' Intervention in their home. There are 8 home visits (4 for Sensitivity and 4 for Couples Intervention). Because of COVID-19, we now conduct remote visits using Zoom. | Behavioural | Sensitivity and Couples Intervention |
Primary outcome
Change in Parental Sensitivity
Time frame: 12-months
Observational measure of parent sensitivity during infant-parent interactions
Change in Child Care Activities Scale
Time frame: 12-months
Parent-report questionnaire assessing degree of involvement with infants at home, reflecting percent time engaging in each activity. Subscales include: Direct Care, Indirect Care, Play Activities, and Total score all ranging from 0 - 100. Higher values mean higher percentage of time spent in that caretaking activity. Scores are averaged to create the subscales and total score.
Change in Parenting Stress Index - Short Form Version III
Time frame: 12 months
Parent-report questionnaire assessing degree of stress about roles as a parent. Subscales include: Parental Distress (scale range from 5 - 60; 33 and higher = 85th percentile); Parent-Child Dysfunctional Interaction (scale range 5 - 60; 26 and higher = 85th percentile); Difficult Child (scale range 5 - 60; 33 and higher = 85th percentile); Total Score (scale range 15 - 180; 86 and higher = 85th percentile). Higher values mean greater levels of parenting stress. Scores are summed to create subscales and the total score.
Change in Parenting Sense of Competence Scale
Time frame: 12-months
Parent-report measure of self-efficacy in their role as a parent. Subscales include Satisfaction (cale range 9 - 54); Efficacy (scale range 8 - 48). Total Score (scale range 17 - 102). Higher values indicate a greater satisfaction, efficacy, and total sense of competence. Scores are summed to create the subscales and total score.
Change in Spousal Attachment Questionnaire
Time frame: 12-months
Parent report questionnaire assessing parents' security in their relationships with each other. Subscales include Preoccupied Attachment (scale range 1 - 7); Fearful Attachment (scale range 1 - 7); Secure Attachment (scale range 1 - 7). Higher values mean greater levels of that type of attachment to spouse. Scores are averages of item sets.
Change in Conflict and Problem Solving Scale
Time frame: 12-months
Parent report questionnaire assessing conflict strategies in spousal relationship. Subscales include Cooperation (scale range 0 - 36); Avoidance and Capitulation (scale range 0 - 60); Stonewalling (scale range 0 - 42); Verbal Aggression (scale range 0 - 48); Physical Aggression (scale range 0 - 42); Child Involvement (scale range 0 - 30); Conflict Resolution (scale range 0 - 39). Higher scores indicate greater levels of use of conflict strategies or greater resolution. Item sets are summed to create subscale scores.
Change in O'Leary Porter Scale
Time frame: 12-months
Parent report questionnaire assessing children's exposure to marital conflict. There is a total score (scale range 0 - 36). Higher values indicate more conflict. Items are summed to create the total score.
Change in Brief Infant Toddler Emotional Assessment
Time frame: 12-months
Parent questionnaire evaluating children's behavior problems and competence. Subscales include Problems (scale range 0 - 66); Competencies (scale range 0 - 22); Externalizing problems (scale range 0 - 12); Internalizing (scale range 0 - 16); Dysregulation (scale range 0 - 16); Autism Spectrum Disorder (scale range 0 - 17). Higher scores indicate higher levels of each construct or higher screening value for Autism Spectrum Disorder. Scores are summed.
Mother-Infant Attachment
Time frame: 12 months
Observational ratings of infant attachment security with mothers from the Strange Situation; with COVID-19, we no longer do in-person assessments so we now use a modified version of the Attachment Q-Sort which is an interview with mothers over zoom.
Father-Infant Attachment
Time frame: 10 months
Observational ratings of infant attachment security with fathers from the Strange Situation; with COVID-19, we no longer do in-person assessments so we now use a modified version of the Attachment Q-Sort which is an interview with fathers over zoom.
Change in Couples' communication styles
Time frame: 12-months
Observational measure of parents' conflict styles during discussions
Change in Infant Affect Regulation
Time frame: 12-months
Observational measure of infants' affective and regulatory behaviors during parent-child interactions and during couples' discussions
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 1 Jul 2026.
- Individual participant dataSharing planned: No. At the close of the study, subject data will be deidentified and individual participant data will no longer be available for further use.
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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. This study is not recruiting at the moment.
Samantha Murray-Perdue, Ph.D. principal investigator
Colorado State University
E M Cummings, Ph.D. principal investigator
University of Notre Dame
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitivity Intervention, Couples' Intervention and Sensitivity and Couples' Intervention in people with Behavior, Infant, run by Colorado State University at 2 sites in United States.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parental Sensitivity (time frame: 12-months). The study lists 12 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 1 Jul 2026.