FIT Families Multicomponent Obesity Intervention for African American Adolescents

May 4, 2026 updated by: Mohan Madisetti, Medical University of South Carolina

Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step From the ORBIT Initiative

Obesity is one of the most prevalent medical problems facing children and adolescents today, particularly among African American adolescents where the rate is alarmingly high. This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to meet the unique needs of African American adolescents with obesity and their caregivers, against a credible attention control condition. This study has considerable public health relevance because it is delivered by Community Health Workers, maximizing the potential for the intervention to be sustained, and may reduce obesity-related health problems for a vulnerable population of adolescents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The alarming rates of obesity among children and adults, particularly among ethnic minorities, has been identified by the National Institutes of Health as one of the most serious public health challenges facing our nation in the 21st century. South Carolina (SC), part of the "Stroke Belt," has the 3rd highest obesity rate among US children at 39.2% and the 12th highest obesity rate among US adults at 32.3%. Unfortunately, African Americans in SC are disproportionately more likely to be overweight or obese (75.7% of adults, 40% of children), which places them at considerable high-risk for obesity-related diseases such as asthma, Type 2 diabetes, cardiovascular disease, hypertension, stroke, and some forms of cancer. This public health challenge is compounded by the lack of available intervention strategies specially tailored to meet the unique needs of ethnic minorities. This R01 randomized clinical trial, informed by the results from a recently completed NHLBI/NICHD center grant ("FIT Families Project," U01HL097889; PI-Naar) that followed the National Heart, Lung, and Blood Institute, Obesity Related Behavioral Intervention Trials (ORBIT) model for developing behavioral interventions, will examine the efficacy of FIT Families compared to a credible attention control condition. Each of four evidence-based behavioral components of FIT Families (home-based services, contingency management, motivational interviewing, cognitive behavioral skills training) were culturally tailored and optimized through a proof of concept sequential multiple randomized trial that produced weight loss among African American adolescents, a large and understudied population. One hundred and eighty obese African American adolescents aged 12-17 and their primary caregiver will be randomly assigned to one of two treatment conditions: 1) FIT Families or 2) Home-Based Family Support (HBFS) attention control condition. It is predicted that FIT Families will lead to greater reductions in adolescent and caregiver percent overweight, and increases in physical activity and the use of evidence-based weight management behaviors (self-monitoring of diet and exercise). If effective, FIT Families, which was carefully developed and adapted through successive Phases of ORBIT, has the potential to reduce disparities in obesity-related diseases (cardiovascular and metabolic) by addressing multiple risk factors among African American families and their adolescent children. Thus, this project has high significance in terms of potential public health impact and reduction in obesity related healthcare costs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Phillippe B Cunningham, Ph.D.
  • Phone Number: 843-876-1800
  • Email: cunninpb@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Division of Global and Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. adolescents (ages 12-17) self-identifying as AA,
  2. BMI≥95th percentile for age and gender
  3. primary caregiver who is either overweight (BMI 25.0 to 29.9) or obese (BMI≥30) and willing to participate in treatment
  4. adolescent residing primarily with the primary caregiver within 30 miles of the MUSC, and 5) adolescent and caregiver obtain PA clearance from a health care provider (see Protection of Human Subjects).

Exclusion Criteria:

  1. obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics);
  2. secondary to a chronic condition (e.g., Down syndrome, Prader-Willi syndrome, Cushing's syndrome).

Exclusion criteria that apply to both adolescents and caregivers are:

  1. pregnancy,
  2. thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
  3. serious cognitive impairment (e.g., inability to complete questionnaires)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FIT Families
1. FIT Families is a 6 month comprehensive multicomponent family-based behavioral intervention delivered by Community Health Workers (CHWs). FIT Families integrates home-based service delivery, Motivational Interviewing (MI; intrinsic motivation), Cognitive Behavior Skills Treatment (CBST; skills acquisition), supervised physical activity (PA), and Contingency Management (CM; extrinsic motivation). Sessions occur twice weekly for the first three months, and weekly for the second three months.
Behavioral: FIT
FIT Families is a home-based intervention that works with youth and caregivers to lose weight and improve their health. The intervention lasts 6 months. Sessions are held twice a week for the first 3 months and then once a week for the second 3 months. These sessions will take place in home with a community health worker. In addition, participants will have the opportunity to earn prizes for completing certain intervention related tasks.
Active Comparator: Home-Based Family Support
2. Home-based Family Support (HBFS). Adolescents and their primary caregiver randomly assigned to HBFS will receive 6 months of weekly, home-based, client-centered, non-directive supportive family counseling.
Behavioral: Home-Based Family Support
Home-Based Family Support Group will receive six months of weekly family counseling in the home. The weekly visits have 3 goals: 1) provide basic education in nutrition and physical recommendations for adolescent and adult obesity; 2) assess and monitor weight, physical activity, and diet via logs; and 3) offer opportunities to discuss barriers they identify to adherence to weight loss recommendations. The HBFS CHW will also address non-weight related problems such as peer or family relationship problems during the visits.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Baseline
Height in meters will be obtained using a portable stadiometer.
Baseline
Height
Time Frame: 3-month mid-treatment
Height in meters will be obtained using a portable stadiometer.
3-month mid-treatment
Height
Time Frame: 6-month end of treatment
Height in meters will be obtained using a portable stadiometer.
6-month end of treatment
Height
Time Frame: 12-month follow-up
Height in meters will be obtained using a portable stadiometer.
12-month follow-up
Weight
Time Frame: Baseline
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
Baseline
Weight
Time Frame: 3-month mid-treatment
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
3-month mid-treatment
Weight
Time Frame: 6-month mid-treatment
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
6-month mid-treatment
Weight
Time Frame: 12-month follow-up
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
12-month follow-up
Percent of body fat
Time Frame: Baseline
Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot
Baseline
Percent of body fat
Time Frame: 3-month mid-treatment
Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot
3-month mid-treatment
Percent of body fat
Time Frame: 6-month end of treatment
Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot
6-month end of treatment
Percent of body fat
Time Frame: 12-month follow-up
Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot
12-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent overweight
Time Frame: Baseline
Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.
Baseline
Percent overweight
Time Frame: 3 month mid-treatment
Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.
3 month mid-treatment
Percent overweight
Time Frame: 6 month end of treatment
Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.
6 month end of treatment
Percent overweight
Time Frame: 12 month follow-up
Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.
12 month follow-up
Physical activity
Time Frame: baseline
Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns
baseline
Physical activity
Time Frame: 3-month mid-treatment
Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns
3-month mid-treatment
Physical activity
Time Frame: 6-month end of treatment
Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns
6-month end of treatment
Physical activity
Time Frame: 12-month follow-up
Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns
12-month follow-up
Self-monitoring of physical activity (PA)
Time Frame: Daily for six months during treatment
Self-Monitoring of PA is assessed using daily diary logbooks completed on line
Daily for six months during treatment
Self-monitoring of Dietary Intake
Time Frame: Daily for six months during treatment
Self-Monitoring of Dietary Intake is assessed using daily diary logbooks completed on line
Daily for six months during treatment
Symptoms of Metabolic Syndrome
Time Frame: Baseline
Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.
Baseline
Symptoms of Metabolic Syndrome
Time Frame: Baseline
Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.
Baseline
Symptoms of Metabolic Syndrome
Time Frame: 3-month mid-treatment
Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.
3-month mid-treatment
Symptoms of Metabolic Syndrome
Time Frame: 3-month mid-treatment
Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.
3-month mid-treatment
Symptoms of Metabolic Syndrome
Time Frame: 6-month end of treatment
Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.
6-month end of treatment
Symptoms of Metabolic Syndrome
Time Frame: 6-month end of treatment
Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.
6-month end of treatment
Symptoms of Metabolic Syndrome
Time Frame: 12-month follow-up
Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.
12-month follow-up
Symptoms of Metabolic Syndrome
Time Frame: 12-month follow-up
Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.
12-month follow-up
Hemoglobin A1c (HbA1c)
Time Frame: Baseline
HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.
Baseline
Hemoglobin A1c (HbA1c)
Time Frame: 3-month mid-treatment
HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.
3-month mid-treatment
Hemoglobin A1c (HbA1c)
Time Frame: 6-month end of treatment
HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.
6-month end of treatment
Hemoglobin A1c (HbA1c)
Time Frame: 12-month follow-up
HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.
12-month follow-up
Flanker task
Time Frame: Baseline
Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.
Baseline
Flanker task
Time Frame: 6-month end of treatment
Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.
6-month end of treatment
Flanker task
Time Frame: 12-month follow-up
Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.
12-month follow-up
List Sorting test
Time Frame: Baseline
Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10).
Baseline
List Sorting test
Time Frame: 6-month end of treatment
Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10).
6-month end of treatment
List Sorting test
Time Frame: 12-month follow-up
Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10).
12-month follow-up
Delayed Reward Discounting Task
Time Frame: Baseline
Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.
Baseline
Delayed Reward Discounting Task
Time Frame: 6-month end of treatment
Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.
6-month end of treatment
Delayed Reward Discounting Task
Time Frame: 12-month follow-up
Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.
12-month follow-up
NEURO-QOL
Time Frame: Baseline
self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured.
Baseline
NEURO-QOL
Time Frame: 6-month end of treatment
self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured.
6-month end of treatment
NEURO-QOL
Time Frame: 12-month follow-up
self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured.
12-month follow-up
Brief Symptom Inventory
Time Frame: Baseline
Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress.
Baseline
Brief Symptom Inventory
Time Frame: 6-month mid-treatment
Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress.
6-month mid-treatment
Brief Symptom Inventory
Time Frame: 12-month end of treatment
Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress.
12-month end of treatment
PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms
Time Frame: Baseline
Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression.
Baseline
PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms
Time Frame: 6-month mid-treatment
Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression.
6-month mid-treatment
PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms
Time Frame: 12-month follow-up
Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression.
12-month follow-up
PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms
Time Frame: Baseline
Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety.
Baseline
PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms
Time Frame: 6-month end of treatment
Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety.
6-month end of treatment
PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms
Time Frame: 12-month follow-up
Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety.
12-month follow-up
Working Alliance Inventory
Time Frame: Monthly during the six months of treatment.
Quality of the therapeutic relationship. The WAI is scored on a 7-point Likert-type scale ranging from 1 (never) to 7 (always. Subscales can range from 12-83 and can be summed to obtain a total score-which range from 36-252. Higher scores reflect more positive ratings of the working alliance.
Monthly during the six months of treatment.
Service Utilization Questionnaire
Time Frame: Baseline
Other services the youth may receive besides treatment conditions
Baseline
Service Utilization Questionnaire
Time Frame: 3-month mid-treatment
Other services the youth may receive besides treatment conditions
3-month mid-treatment
Service Utilization Questionnaire
Time Frame: 6-month end of treatment
Other services the youth may receive besides treatment conditions
6-month end of treatment
Service Utilization Questionnaire
Time Frame: 12-month follow-up
Other services the youth may receive besides treatment conditions
12-month follow-up
Parent Adolescent Relationship Questionnaire (PARQ)
Time Frame: Baseline
The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship.
Baseline
Parent Adolescent Relationship Questionnaire (PARQ)
Time Frame: 6-month end of treatment
The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship.
6-month end of treatment
Parent Adolescent Relationship Questionnaire (PARQ)
Time Frame: 12-month follow-up
The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship.
12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Wayne State University
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohan Madisetti, Ph.D., Medical University of South Carolina
  • Principal Investigator: Phillippe B Cunningham, PhD, UTHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00106021
  • 161HL155793-01 (Other Grant/Funding Number: National Heart, Lung, and Blood Institute (NHLBI))
  • 4R33HL155793-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the expiration of the study locked data files and variable and scale dictionaries will be made available to the NIH for archiving and sharing with other researchers, in accordance with NIH policies. The Contact PI (Cunningham) will ensure that all datasets provided will be prepared in accordance with NHLBI requirements for data repository and associated documentation for submission to the Biological Specimen and Data Repository Information Coordinating Center; NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies; and NHLBI Guidelines for Data Set Preparation. Results from the proposed study will be presented in required reports to NIH. Additionally, results will be presented to clinical researchers, clinical treatment organizations, and state and national legislative bodies as requested. Within one year of completion of the study and publication of the main study findings we will make available the datasets publicly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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