- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924167
The Weaving Healthy Families Program
The Weaving Healthy Families Program to Promote Wellness and Resilience and Prevent Alcohol and Other Drug Abuse and Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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New Orleans, Louisiana, United States, 70125
- Catherine McKinley
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion Criteria for community health representatives (CHR)s.
- 18 years of age or older
- have at least a high school degree
- have experience and/or interest in working with tribal children and families.
Exclusion criteria:
- having less than a high school degree
- not having experience with tribal families
Inclusion criteria for families
- includes written consent for adults and assent for children ages 12-17.
- at least one parent/caregiver who is a member of the focal tribe and at least one child, aged 12-18 living in the household
Exclusion Criteria:
- current protective order
- current intimate partner violence (IPV) record will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Families Receiving Weaving Healthy Families Intervention
The Weaving Healthy Families curriculum is a cognitive-behavioral, support group model for high-risk families related to alcohol, tobacco, or other drugs (ATOD) and/or or domestic violence, child abuse, or neglect.
This curriculum is tailored for all ages (i.e., (a) parents/caregivers; (b) early childhood (5-7); (c) children (8-11); and (d) adolescent (12-17) and is aimed at reducing alcohol and other drug (AOD) abuse, promote unity, address mental health problems, strengthen parenting skills, and bolster wellness and resilience.
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The Weaving Healthy Families program is created from integrating the widely disseminated, ecological, innovative, and culturally grounded Framework of Historical Oppression, Resilience, and Transcendence (FHORT) with the the Celebrating Families!
evidenced-based program (EBP).
The goal of this program is to reduce and postpone Alcohol and other Drug (AOD) use, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth.
This intervention seeks to promote wellness by targeting key behavioral (AOD), mental/emotional (emotional regulation/anger management, cognitions, resilience), social and familial (healthy and safe relationships, the family environment, and parenting), cultural (values, traditions), and physical (nutrition) factors.
Other Names:
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No Intervention: Families who have not yet receive the Weaving Healthy Families
Baseline group --data will be collected prior to receiving the intervention in this stepped-wedge trial design.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the AUDIT= Alcohol Use Disorders Identification Test
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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The 10-item AUDIT identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults.
Scores for each question range from 0 to 4, with the first response for each question (eg never) scoring 0, the second (eg less than monthly) scoring 1, the third (eg monthly) scoring 2, the fourth (eg weekly) scoring 3, and the last response (eg.
daily or almost daily) scoring 4. For questions 9 and 10, which only have three response, the scoring is 0, 2 and 4 (from left to right).
A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the DAST= Drug Abuse Screening Test
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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A 10-item form used to assess drug use with adults. Participants receive 1 point for every "yes" answer with the exception of question #3, for which a "no" answer receives 1 point. Degree of problems by score: 0=no problems reported, 1-2 = low level, 3-5=moderate level, 6-8=substantial level, 9-10=severe level. |
Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the AADIS= Adolescent Alcohol and Drug Involvement Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Adolescent alcohol and other drug (AOD) use will be assessed using the AADIS, which assesses frequency of AOD as well as 14 items assessing severity of AOD misuse.
Scores are added with results indicating: Scores of 0 = No alcohol or other drug use.
Scores of 1-36 = Alcohol and/or other drug use present, does not reach threshold for substance use disorder based on DSM-IV criteria.
Scores of 37 or higher = Alcohol and/or other drug use present which may reach DSM IV criteria.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the CRAFFT=Car, Relax, Alone, Forget, Friends, Trouble
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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A 9-item evidenced-based screening tool, will be used to assess AOD misuse, (alcohol and drug use separately and holistically).
9 items.
1-3 number of days used substances.
4-9 yes, no responses with each "yes" response scoring 1 point.
A total score of 2 or higher is a positive screen, indicating a need for additional assessment.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the FES=Family Environment Scale-Short Form
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Assesses key components of healthy functioning through the following subscales: cohesion, expressiveness, conflict, independence, achievement orientation, intellectual and cultural orientation, active-recreational orientation, moral-religious emphasis, organization, and control.
90 item scale.
Respondents mark whether each item is true (1) = 1 or false (2) =0 for them.
Scoring: To determine a person's raw score (RS), count the number of responses in each subscale, and enter the total in the RS box at the bottom.
Scores range from 0-10 for each subscale, with higher scores indicating higher levels of that construct.
To determine the family's mean RS for each subscale, average the subscale raw scores for all members of that family.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the FRI=Family Resilience Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Assesses family resilience in current family and family of origin.
Scoring: Add responses for each item.
Total scores range from 0-20, with higher scores indicating a higher degree family resilience.
Each of the items can be thought of as a protective factor, cumulatively contributing to the holistic measure of family resilience.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the CD-RISC=Conner-Davidson Resilience Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Assesses individual or psychological resilience.
10-item scale.
Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4.
For the CD-RISC-10, the total score ranges from 0-40.
Higher scores indicate higher levels of psychological resilience.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the CTS-2=Conflict Tactics Scale 2
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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The CTS2 is a comprehensive self-reported inventory designed to measure five scales: Negotiation (positive verbal conflict resolution skills), Psychological Aggression, Physical Assault, Sexual Coercion, and Injury.
Respondents rate each item on a 7-point Likert- style frequency scale (0 = this has never happened before, 1 = once in the past year, 2 = twice in the past year, 3 = 3-5 time in the past year, 4 = 6-10 times in the past year, 5 = 11-20 times in the past year, 6 = more than 20 times in the past year, and 7 = not in the past year, but it did happen before).
To create interpretable scores, values 1 and 2 remained the same, and values 3 through 6 were recoded to be the midpoints (3 = 4, 4 = 8, 5 = 15, 6 = 25).
Frequency scores (how often) for each subscale are added (Range 1-12 for frequency, higher scores indicating higher levels of each subscale).
Dummy are created with each item and subscale for prevalence (1=yes in the past year; 0=not in the past year).
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the DAS-SF/DAS-C= Dysfunctional Attitudes Scale-Short Form/Child
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Assesses dysfunctional attitudes, which have been shown to be precursors to depression and stress.
Items are on a 4-point Likert scale (1-Totally agree to 4-Totally disagree).
Items should be scored so that total score reflects greater dysfunctional attitudes.
This means that most items will be reverse coded.
Subtracting 5 from an item score will reverse score that item.
Items are on a 4-point Likert scale (1-Totally agree to 4-Totally disagree).
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the SWLS=Satisfaction with Life Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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A short measure of life satisfaction.
The SWLS is a five-item scale designed to measure global judgements about one's life satisfaction.
Respondents indicated how much they agreed or disagreed with each of the five items using a seven-point scale that ranged from 'strongly disagree' to 'strongly agree'.
The summed scale ranged from 5-35, with higher scores indicating greater life satisfaction.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the DERS-18= Difficulties in Emotional Regulation Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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An 18-item measure of emotional regulation and anger management.
Sum items for each subscale with Items 1, 4, and 6 being reverse-coded.
Add subscale totals for the total summative scale as follows: Awareness (# 1, 4, 6); Clarity (#2, 3, 5); Goals (#8, 12, 15); Impulse (#9, 16, 18); Nonacceptance (#7, 13, 14), and Strategies (#10, 11, 17).
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Change in the BRFSS=Behavioral Risk Factor Surveillance System
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Items taken from the BRFSS on the modules on chronic health, diet, and exercise.
Subscales/items: CDC HRQOL- 4-Physical health, mental health, days not good, 4 items.
Scoring: To obtain this estimate, responses to questions 2 and 3 are combined to calculate a summary index of overall unhealthy days, with a logical maximum of 30 unhealthy days.
Participants were asked whether they had any of 16 chronic health problems (1 yes, 2 no).
Scored to create overall measure of health problems.
Four diet questions about frequency of consuming.
Summed to create mean scores for each item.
4 individual exercise-related questions, individually scored.
4-item HDCM BRFSS (Past 30 days, health-related problems).
Score summed.
With the exception of the full of energy item, higher scores indicate poorer health.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Alabama Parenting Questionnaire-9/ APQ-SF
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Measures five dimensions of parenting.
13-item scale.
Items (e.g.
You threaten to punish your child and then do not actually punish him/her) are rated on a 5 point Likert Scale (1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = always).
Higher scores indicate higher ratings of the measured parenting practice (i.e.
Positive Parenting, Inconsistent Discipline, Poor Supervision).
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the CSAP = Center for Substance Abuse Prevention (Minority Initiative)
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Secondary measures of AOD abuse among youth and adults.
41 items answered on likert-type scales, which are summed and averaged.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the PSDQ-SF=Parenting Styles and Dimensions Questionnaire-Short Form
Time Frame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Measure of parenting styles, which are associated with more optimum and less optimum parent-child relationships.
124-item scale.
There are 27 items in the Authoritative Construct with the following subscales: Warmth and Involvement, Reasoning and Induction, Democratic Participation, and Good Natured/Easy Going.
There are 20 items for the Authoritarian Construct with the following subscales: Verbal Hostility, Corporal Punishment , Non-reasoning, Punitive Strategies, and Directiveness.
There are 15 items for the Permissive Construct with the following subscales: Lack of Follow Through, Ignoring Misbehavior, and Self Confidence.
Each item of the scale were evaluated with the five points likert described as, "never" (1) to "always" (5) .
Scores for each authoritarian, authoritative, and permissive parenting styles are achieved by creating the mean for each construct with higher scores indicating higher levels of the given construct (Ranging from 1-5).
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Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Change in the SRHP=Self-Rated Health Practices
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of health self-efficacy.
The 28-item Self-Rated Abilities for Health Practices Scale (SRHP), which is a 5-point scale ("not at all" = 0 to "completely" = 4) to measure perceived ability to implement health promoting behavior.
Scores range from 0-112, with higher scores indicating greater health practices self-efficacy.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the Kidscreen
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of health self-efficacy among youth.
27 items.
Items are summed and/or means are calculated for a total health-related quality of life.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the GAD-7=Generalized Anxiety Disorder
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of anxiety symptoms for adults.
This seven-item, self-report questionnaire focused on symptoms of feeling nervous, anxious or on edge, not being able to stop or control worrying, and having trouble relaxing.
Respondents rated the how often they experienced these symptoms over the past two weeks (0 = not at all, 3 = nearly every day).
Scores ranged from 0-21 with higher scores indicating more severe symptoms.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the SCARED=Screen for Child Anxiety Related Emotional Disorders
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of anxiety symptoms for youth.
41-item scale.
Responses range from 1=Not True or Hardly Ever True to 3=Very True or Very Often True.
Items are summed to form a total score.
Scores range from 41-123.
Higher scores indicated higher levels of anxiety related symptomatology.
A score of 25 or greater is indicative of the presence of an anxiety disorder.
Scale include subscales with scores in parenthesis for each indicative of levels of clinical significance for School Avoidance (3), Social Anxiety Disorder (8), Separation Anxiety Disorder (5), Panic Disorder (7), and Significant Somatic Symptoms (7).
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the PHQ-9= Patient Health Questionnaire
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of depressive symptoms for adults.
Participant's indicate how often over the past two weeks they were bothered by depressive symptoms.
For each of the nine items, four response options were available.
These were: 0 = 'not at all', 1 = 'several days', 2 = 'more than half the days', and 3 = 'nearly every day'.
When summed, the nine scale items had a possible range of 0 to 27 and the total score corresponded to an individual's level of depressive symptoms along a continuum that was scored as: minimal (score of 0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression.
PHQ-9 scores of 10 or higher indicate clinical depression, a cut point validated across numerous studies.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the PC-PTSD=Primary Care PTSD Screen
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of PTSD for adults.
Preliminary results from validation studies suggest that a cut-point of 3 on the PC-PTSD-5 (e.g., respondent answers "yes" to any 3 of 5 questions about how the traumatic event(s) have affected them over the past month) is optimally sensitive to probable PTSD.
Optimizing sensitivity minimizes false negative screen results.
Using a cut-point of 4 is considered optimally efficient.
Optimizing efficiency balances false positive and false negative results.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the C-SSRS=Columbia-Suicide Severity Rating Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of suicide symptoms for adults.
Add symptoms of suicidal ideation (0/1).
Any score greater than 0 indicates some level of suicide ideation.
A score of 4 (active suicidal ideation with some intent to act) or 5 (active suicidal ideation with specific plan and intent) on suicidal ideation indicate serious suicidal ideation.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the SHALOM= Spiritual Health and Life-Orientation Measure
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of spiritual health and wellness.
Spiritual well-being is assessed using the Spiritual Health and Life-Orientation Measure (SHALOM), which is a 42-item scale.
Calculate mean scores for each of the 4 domains.
Difference between the ideals and lived experience scores can be used to investigate the level of spiritual harmony or dissonance.
Includes two additional questions (importance of religion, importance of spirituality) which should be scored separately.
Item responses range from 1 (very low) to 5 (very high).
These are added and an overall mean is created, with higher scores indicating higher spiritual well-being.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in Communal Mastery Scale
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of community resilience and cohesion.
10-item scale.
Items were summed to find total scores of communal mastery.
Total scores range from 10 to 40 with higher scores indicating more community resilience and cohesion (a more optimum outcome).
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the SSI=Social Support Index
Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Measure of social, familial, and community support.
The 17 items are coded as follows: 1 Strongly disagree; 2 Disagree; 3 Neutral; 4 Agree; or 5 Strongly Agree.
Scores are added to indicate levels of social and familial support (higher scores, higher support).
Some items (7, 9, 10, 14, 17) are reversed coded.
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Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
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Change in the IGI=In-Group Identification
Time Frame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Measure of ethnic identity.
Measure mean score across items.
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Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Change in the HOS=Historical Oppression Scale
Time Frame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Measure of perceived historical oppression.
Add responses for each item.
Total scores range from 10-50, with higher scores indicating a higher degree of reported historical oppression.
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Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Change in the HLS=Historical Loss Scale-R
Time Frame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Measure of perceived historical loss.
The Historical Loss Scale (HLS) is an adapted version, creating a 15 time scale measuring the frequency with which people think of historical loss from a continuum of the following: 1 = 'several times a day'; 2 = 'daily'; 3 = 'weekly'; 4 = 'monthly'; 5 = 'yearly or at special times'; and 6 = 'never'.
The following items were added the following culturally relevant items to the original 12-item scale: "Loss of family unity and increase in family violence"; "Loss of respect for women"; and "Losses from man-made disasters, flooding, pollution, and destruction of natural resources."
Responses were summed (range = 15-75) and higher values indicated a higher degree of historical loss.
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Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Change in the EDS=Everyday Discrimination Scale
Time Frame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Measure of perceived discrimination.
This 5-item scale measures the frequency 5 (every day) to 0 (never) that people experience discrimination, with higher scores indicating greater perceived discrimination.
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Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Change in the ACE=Adverse Childhood Experiences
Time Frame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Measure of child maltreatment and childhood stress and trauma.
Yes/no items are added indicating total numbers of adverse childhood events.
Higher scores more adverse experiences.
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Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
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Change in the ICBS= Implementation Citizenship Behavior Scale
Time Frame: Change from from Baseline and 12 Month Follow-up.
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Measure of facilitator behaviors and attitudes about the intervention.
The six items of this scale are added (0=not at all to 5=frequently if not always) with higher scores indicating higher levels of practitioners exceeding expected job tasks.
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Change from from Baseline and 12 Month Follow-up.
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Change in the Intervention AS-36= Evidence-based Practice Attitude Scale
Time Frame: Change from from Baseline and 12 Month Follow-up.
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Measure of consolidated framework for implementation research.
Items for this 36-item scale are added with 0=not at all to 5-very great extent, with higher scores indicating the better fit for this intervention.
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Change from from Baseline and 12 Month Follow-up.
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Change in the PSI=Program Sustainability Index
Time Frame: Change from from Baseline and 12 Month Follow-up.
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Measure of Program Sustainability.
Items are added from 0=not at all true to 2=very much true for an overall measure of program sustainability.
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Change from from Baseline and 12 Month Follow-up.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1372
- 5R01AA028201-03 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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