Active — Not RecruitingNot Applicable

Efficacy of Family Programs for Improving Child and Family Health and Development

United States1,005 participantsStarted 2017-01-11

Plain-language 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. 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.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Parents cohabiting * Both mothers and fathers agree to participate * Healthy infants with no known health problems Exclusion Criteria: * Discovery of developmental delays or health problems in infants

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Parental Sensitivity

Timeframe: 12-months

Change in Child Care Activities Scale

Timeframe: 12-months

Change in Parenting Stress Index - Short Form Version III

Timeframe: 12 months

Change in Parenting Sense of Competence Scale

Timeframe: 12-months

Change in Spousal Attachment Questionnaire

Timeframe: 12-months

Change in Conflict and Problem Solving Scale

Timeframe: 12-months

Change in O'Leary Porter Scale

Timeframe: 12-months

Change in Brief Infant Toddler Emotional Assessment

Trial details

NCT IDNCT03367845

SponsorColorado State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-30

View on ClinicalTrials.gov More Behavior, Infant trials

Plain-language summary

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Parental Sensitivity

Timeframe: 12-months

Change in Child Care Activities Scale

Timeframe: 12-months

Change in Parenting Stress Index - Short Form Version III

Timeframe: 12 months

Change in Parenting Sense of Competence Scale

Timeframe: 12-months

Change in Spousal Attachment Questionnaire

Timeframe: 12-months

Change in Conflict and Problem Solving Scale

Timeframe: 12-months

Change in O'Leary Porter Scale

Timeframe: 12-months

Change in Brief Infant Toddler Emotional Assessment