Substance AbuseNCT00373750
Cradling Our Future Through Family Strengthening Study
A study testing Family Spirit Intervention in people with Substance Abuse and Post-partum Depression, run by Johns Hopkins Bloomberg School of Public Health at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American… Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Post-partum Depression, Depression
- What is being tested?
- Family Spirit Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant AI females aged 12 to 19 years old at time of conception.
- Gestational age of 28 weeks or less (in order to complete intervention prior to delivery).
- Parent/guardian consent for youth under 18 years old.
- Reside within 1-hour transportation range (50 miles) of the local Indian Health Service medical facility.
Who cannot join
- Current participation in other mental or behavior health research project.
- Factors that preclude full participation, identified at baseline and after caseness review, including: unstable and severe medical, psychiatric or drug use problem; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life event such as physical or sexual abuse, or victim of a violent crime that requires specific and high intensity intervention or out of home placement; or chronic pattern of unstable caretakers or living situation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, 21205
Johns Hopkins Center for American Indian Health
Fort Defiance, Arizona, 86540
Johns Hopkins Center for American Indian Health
San Carlos, Arizona, 85550
Johns Hopkins Center for American Indian Health
Tuba City, Arizona, 86045
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, 85941
About this study
Official title: In-home Prevention of SA Risks for Native Teen Families
The purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American reservation communities. The effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of mothers who receive the intervention plus assisted transportation to prenatal and well baby visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study period.
Read the detailed description
American Indians (AIs) in reservation communities have the poorest health, education and socioeconomic status of any racial or ethnic group in the U.S., placing AI youth at increased risk for drug abuse (alcohol, marijuana, tobacco, etc.) and adverse health and behavior outcomes. This study focuses on one of the most vulnerable groups of reservation-based AIs-AI teen mothers and their children.
Over the past two decades a number of research-based health promotion and drug abuse prevention programs for youth have been found to be effective. Of these, parenting interventions have been found to be more effective than other types of interventions. Home visiting programs for young, high-risk mothers have been designed to impact a wide range of outcomes--parenting, child and maternal health and behavior outcomes. More than 40 studies have been published since 1982 supporting the short and long-term efficacy of home visiting programs delivered during pregnancy and early childhood for low-income families. Positive outcomes have been demonstrated for improved parenting and the home environment; increased social support for mothers and children from extended family members and improved maternal health and behavior outcomes; increased birth spacing; improved children's health and behavior outcomes; prevention of child abuse and neglect; and reduced drug use.
AI teen mothers and their offspring are arguably the most vulnerable and underserved population at risk for drug abuse and adverse health and behavior outcomes in the U.S. Given their high-risk status, pregnant AI teens are likely to benefit from a parenting-focused, home visiting intervention. Cultural support for developing individual strengths through a family-based model and the noted cultural relevance of employing AI paraprofessionals are expected to enhance participants' outcomes. As nearly half of AI women begin child-bearing in adolescence, improvement in outcomes of teen mothers and their offspring could substantially impact the public health and welfare of AI communities.
Both nurses and paraprofessionals have been utilized in effective home visiting programs. However, the shortage of indigenous nurses in reservation communities renders an AI nurse-delivered, home visiting intervention unfeasible for the participating communities at this time. Further, young AI women's discomfort with health care delivered by non-Indians and the potential for cultural barriers with non-Indian home visitors provides an additional rationale for AI paraprofessionals as home visitors.
Successful home visiting programs maintain a standard for frequency and dosage of visits, employ strategies for participant retention, provide intensive training, frequent direct supervision and intensive quality assurance measures. For this study, we will maintain the highest standards for dosage, retention strategies, home visitor training and supervision, and quality assurance. The core content of the curriculum is based on American Academy of Pediatrics' comprehensive guidelines for preparing mothers to care for infants and young children, with cultural adaptations derived through guidance from our Native Advisory Board and an iterative process of community input.
- Conditions
- Substance Abuse, Post-partum Depression, Depression
- Being tested
- Family Spirit Intervention
- Keywords
- Native American health, Teen pregnancy, Family strengthening, Substance abuse prevention, Injury prevention
- Medical subject headings
- Substance-Related Disorders, Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Spirit InterventionProcedure or surgery
The Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format.
| Study group | Role | What they receive |
|---|---|---|
| Family Spirit Intervention | Experimental | The Family Spirit Intervention included 43 structured lessons and followed a culturally congruent format. Positive parenting lessons were focused on reducing behaviors (i.e., poor monitoring; coercive interactions;harsh, unresponsive, or rejecting parenting; and abuse/ neglect) associated with early childhood behavior problems, including externalizing, internalizing, and dysregulation problems. Receives: Procedure: Family Spirit Intervention |
| Optimized Standard Care Control Group | No intervention | Optimized standard care consisted of transportation to recommended prenatal and well-baby clinic visits, pamphlets about child care and community resources, and referrals to local services. It also addressed access barriers to health care for young mothers and children, and it overcame concerns that home-visiting programs have operated in parallel, not in partnership, with pediatric care. Family health liaisons conducted the optimized standard care and were not trained in the Family Spirit intervention, to avoid contamination of the control condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in parental competence at nine intervals over 39 month study period
Measured: birth-3 year postpartum
Secondary outcomes (4)
Differences in social and emotional competence, and internalizing, externalizing and regulatory problems for children between ages 12-36 months
Measured: birth-3 year postpartum
Moderators and mediators of intervention response for mothers and children.
Measured: birth-3 year postpartum
Increase in maternal outcomes at nine intervals over 39 month study period
Measured: birth-3 year postpartum
Improved childhood outcomes at nine intervals over 39 month study period
Measured: birth-3 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Allison Barlow, Johns Hopkins Bloomberg School of Public Health
- Investigators
- John Walkup, MD, Principal investigator, Johns Hopkins UniversityAllison Barlow, MA, MPH, Study director, Johns Hopkins Center for American Indian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373750
- Sponsor's protocol ID
- 1R01DA019042-01A1
- Other IDs
- 1R01DA019042-01A1
- Status last verified
- Jan 2015
- First submitted
- 7 Sep 2006
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Barlow A, Varipatis-Baker E, Speakman K, Ginsburg G, Friberg I, Goklish N, Cowboy B, Fields P, Hastings R, Pan W, Reid R, Santosham M, Walkup J. Home-visiting intervention to improve child care among American Indian adolescent mothers: a randomized trial. Arch Pediatr Adolesc Med. 2006 Nov;160(11):1101-7. doi: 10.1001/archpedi.160.11.1101.
PubMed 17088511Nelson KE, Haroz E, Neault N, Goklish N, Coho-Mescal V, Lorenzo S, Richards J, Talaswaima T, Werwie TR, Richardson M, Velasquez-Brawley V, Barlow A. 16-year follow-up of Family Spirit intervention effects on Native American maternal-child outcomes: study protocol. BMC Public Health. 2026 Jul 17. doi: 10.1186/s12889-026-28261-9. Online ahead of print.
PubMed 42464223Haroz EE, Ingalls A, Kee C, Goklish N, Neault N, Begay M, Barlow A. Informing Precision Home Visiting: Identifying Meaningful Subgroups of Families Who Benefit Most from Family Spirit. Prev Sci. 2019 Nov;20(8):1244-1254. doi: 10.1007/s11121-019-01039-9.
PubMed 31432381Barlow A, Mullany B, Neault N, Goklish N, Billy T, Hastings R, Lorenzo S, Kee C, Lake K, Redmond C, Carter A, Walkup JT. Paraprofessional-delivered home-visiting intervention for American Indian teen mothers and children: 3-year outcomes from a randomized controlled trial. Am J Psychiatry. 2015 Feb 1;172(2):154-62. doi: 10.1176/appi.ajp.2014.14030332. Epub 2014 Oct 31.
PubMed 25321149Barlow A, Mullany B, Neault N, Compton S, Carter A, Hastings R, Billy T, Coho-Mescal V, Lorenzo S, Walkup JT. Effect of a paraprofessional home-visiting intervention on American Indian teen mothers' and infants' behavioral risks: a randomized controlled trial. Am J Psychiatry. 2013 Jan;170(1):83-93. doi: 10.1176/appi.ajp.2012.12010121.
PubMed 23409290
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-home Prevention of SA Risks for Native Teen Families
- ClinicalTrials.gov ID
- NCT00373750
- Acronym / sponsor ID
- 1R01DA019042-01A1
- Conditions
- Substance Abuse, Post-partum Depression, Depression
- Keywords
- Native American health, Teen pregnancy, Family strengthening, Substance abuse prevention, Injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Sep 2006 (estimated)
- 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 purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American reservation communities. The effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of mothers who receive the intervention plus assisted transportation to prenatal and well baby visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study period.
Detailed description
American Indians (AIs) in reservation communities have the poorest health, education and socioeconomic status of any racial or ethnic group in the U.S., placing AI youth at increased risk for drug abuse (alcohol, marijuana, tobacco, etc.) and adverse health and behavior outcomes. This study focuses on one of the most vulnerable groups of reservation-based AIs-AI teen mothers and their children.
Over the past two decades a number of research-based health promotion and drug abuse prevention programs for youth have been found to be effective. Of these, parenting interventions have been found to be more effective than other types of interventions. Home visiting programs for young, high-risk mothers have been designed to impact a wide range of outcomes--parenting, child and maternal health and behavior outcomes. More than 40 studies have been published since 1982 supporting the short and long-term efficacy of home visiting programs delivered during pregnancy and early childhood for low-income families. Positive outcomes have been demonstrated for improved parenting and the home environment; increased social support for mothers and children from extended family members and improved maternal health and behavior outcomes; increased birth spacing; improved children's health and behavior outcomes; prevention of child abuse and neglect; and reduced drug use.
AI teen mothers and their offspring are arguably the most vulnerable and underserved population at risk for drug abuse and adverse health and behavior outcomes in the U.S. Given their high-risk status, pregnant AI teens are likely to benefit from a parenting-focused, home visiting intervention. Cultural support for developing individual strengths through a family-based model and the noted cultural relevance of employing AI paraprofessionals are expected to enhance participants' outcomes. As nearly half of AI women begin child-bearing in adolescence, improvement in outcomes of teen mothers and their offspring could substantially impact the public health and welfare of AI communities.
Both nurses and paraprofessionals have been utilized in effective home visiting programs. However, the shortage of indigenous nurses in reservation communities renders an AI nurse-delivered, home visiting intervention unfeasible for the participating communities at this time. Further, young AI women's discomfort with health care delivered by non-Indians and the potential for cultural barriers with non-Indian home visitors provides an additional rationale for AI paraprofessionals as home visitors.
Successful home visiting programs maintain a standard for frequency and dosage of visits, employ strategies for participant retention, provide intensive training, frequent direct supervision and intensive quality assurance measures. For this study, we will maintain the highest standards for dosage, retention strategies, home visitor training and supervision, and quality assurance. The core content of the curriculum is based on American Academy of Pediatrics' comprehensive guidelines for preparing mothers to care for infants and young children, with cultural adaptations derived through guidance from our Native Advisory Board and an iterative process of community input.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Spirit Intervention | Experimental | Procedure: Family Spirit InterventionThe Family Spirit Intervention included 43 structured lessons and followed a culturally congruent format. Positive parenting lessons were focused on reducing behaviors (i.e., poor monitoring; coercive interactions;harsh, unresponsive, or rejecting parenting; and abuse/ neglect) associated with early childhood behavior problems, including externalizing, internalizing, and dysregulation problems. |
| Optimized Standard Care Control Group | No intervention | –Optimized standard care consisted of transportation to recommended prenatal and well-baby clinic visits, pamphlets about child care and community resources, and referrals to local services. It also addressed access barriers to health care for young mothers and children, and it overcame concerns that home-visiting programs have operated in parallel, not in partnership, with pediatric care. Family health liaisons conducted the optimized standard care and were not trained in the Family Spirit intervention, to avoid contamination of the control condition. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant AI females aged 12 to 19 years old at time of conception.
- Gestational age of 28 weeks or less (in order to complete intervention prior to delivery).
- Parent/guardian consent for youth under 18 years old.
- Reside within 1-hour transportation range (50 miles) of the local Indian Health Service medical facility.
Key exclusion criteria (2 listed)
- Current participation in other mental or behavior health research project.
- Factors that preclude full participation, identified at baseline and after caseness review, including: unstable and severe medical, psychiatric or drug use problem; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life event such as physical or sexual abuse, or victim of a violent crime that requires specific and high intensity intervention or out of home placement; or chronic pattern of unstable caretakers or living situation.
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 |
|---|---|---|
| Family Spirit InterventionThe Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format. | Procedure or surgery | Family Spirit Intervention |
Primary outcome
Increase in parental competence at nine intervals over 39 month study period
Time frame: birth-3 year postpartum
4 secondary outcomes
Differences in social and emotional competence, and internalizing, externalizing and regulatory problems for children between ages 12-36 months
Time frame: birth-3 year postpartum
Moderators and mediators of intervention response for mothers and children.
Time frame: birth-3 year postpartum
Increase in maternal outcomes at nine intervals over 39 month study period
Time frame: birth-3 year postpartum
Improved childhood outcomes at nine intervals over 39 month study period
Time frame: birth-3 year postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Background: PubMed 17088511Barlow A, Varipatis-Baker E, Speakman K, Ginsburg G, Friberg I, Goklish N, Cowboy B, Fields P, Hastings R, Pan W, Reid R, Santosham M, Walkup J. Home-visiting intervention to improve child care among American Indian adolescent mothers: a randomized trial. Arch Pediatr Adolesc Med. 2006 Nov;160(11):1101-7. doi: 10.1001/archpedi.160.11.1101.
- Derived from this study: PubMed 42464223Nelson KE, Haroz E, Neault N, Goklish N, Coho-Mescal V, Lorenzo S, Richards J, Talaswaima T, Werwie TR, Richardson M, Velasquez-Brawley V, Barlow A. 16-year follow-up of Family Spirit intervention effects on Native American maternal-child outcomes: study protocol. BMC Public Health. 2026 Jul 17. doi: 10.1186/s12889-026-28261-9. Online ahead of print.
- Derived from this study: PubMed 31432381Haroz EE, Ingalls A, Kee C, Goklish N, Neault N, Begay M, Barlow A. Informing Precision Home Visiting: Identifying Meaningful Subgroups of Families Who Benefit Most from Family Spirit. Prev Sci. 2019 Nov;20(8):1244-1254. doi: 10.1007/s11121-019-01039-9.
- Derived from this study: PubMed 25321149Barlow A, Mullany B, Neault N, Goklish N, Billy T, Hastings R, Lorenzo S, Kee C, Lake K, Redmond C, Carter A, Walkup JT. Paraprofessional-delivered home-visiting intervention for American Indian teen mothers and children: 3-year outcomes from a randomized controlled trial. Am J Psychiatry. 2015 Feb 1;172(2):154-62. doi: 10.1176/appi.ajp.2014.14030332. Epub 2014 Oct 31.
- Derived from this study: PubMed 23409290Barlow A, Mullany B, Neault N, Compton S, Carter A, Hastings R, Billy T, Coho-Mescal V, Lorenzo S, Walkup JT. Effect of a paraprofessional home-visiting intervention on American Indian teen mothers' and infants' behavioral risks: a randomized controlled trial. Am J Psychiatry. 2013 Jan;170(1):83-93. doi: 10.1176/appi.ajp.2012.12010121.
Related trials for Substance Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
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.
John Walkup, MD principal investigator
Johns Hopkins University
Allison Barlow, MA, MPH study director
Johns Hopkins Center for American Indian Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Spirit Intervention in people with Substance Abuse and Post-partum Depression, run by Johns Hopkins Bloomberg School of Public Health at 5 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in parental competence at nine intervals over 39 month study period (time frame: birth-3 year postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373750, which also lists 5 linked publications.
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 12 Jan 2015.