ParentingNCT03751345
Computerized Parenting Intervention
A study testing Parenting Wisely in people with Parenting and Adolescent Problem Behavior, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study will evaluate a low-cost, low-intensity, computer-based model for delivering parenting skills to parents of adolescents in a community mental health clinic. This intervention has the potential to improve public health and community practice by making empirically-supported treatment techniques more… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Adolescent Problem Behavior
- What is being tested?
- Parenting Wisely
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to May 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- be the parent or legal guardian of an adolescent aged 12-17 years
- have an adolescent with clinically elevated disruptive behaviors as indicated by parent report on the Child Behavior Checklist (CBCL; Achenbach, 2000; Aggressive Problems or Oppositional/Defiant Problems T score > 70)
- be willing to receive a parenting intervention
- be fluent in English or Spanish
- be willing to provide written consent and teen willing to provide written assent
Who cannot join
- severe clinical presentations, such as psychosis or developmental delay, at a level that would interfere with the ability to assent or complete assessments
Trial locations and contacts
1 site in 1 country.
Melanie Altemus, BA contact
United States1 site, 1 recruiting
- Recruiting
Gateway Healthcare Inc
Pawtucket, Rhode Island, 02860
MAltemus@lifespan.org
About this study
Official title: Integrating Computer-Assisted Parent Training Therapy Into Community Mental Health Clinic Practice
This study will evaluate a low-cost, low-intensity, computer-based model for delivering parenting skills to parents of adolescents in a community mental health clinic. This intervention has the potential to improve public health and community practice by making empirically-supported treatment techniques more available. We believe this approach will improve the efficiency of treatment delivery by integrating computerized and therapist delivered approaches, and there is potential for significant improvements in efficacy of parent training with this model.
Read the detailed description
This study will evaluate a low cost, low intensity, technology based model for delivering parenting skills to parents of adolescents in a community mental health clinic (CMHC). Specifically, we will test a computer-assisted protocol of Parenting Wisely, a computer based parenting program with previously established efficacy. Such an intervention is consistent with NIMH strategic plan objective 3.3: "to strengthen the application of mental health interventions in diverse care settings by examining community and intervention delivery approaches and how they may affect intervention outcomes." Although this is a pilot effectiveness study, we will gather information to inform future implementation efforts including the feasibility and acceptability of the intervention. Additionally, we will conduct qualitative interviews with relevant stakeholders (providers/program managers) to better understand barriers and facilitators of adoption and sustainability. This goal will help increase the likelihood of a successful, future larger trial across multiple CMHCs due to its focus on external validity and implementation barriers when making critical design decisions. This approach mitigates a major criticism of traditional efficacy/effectiveness studies, i.e. that the methods do not translate well to the community due to cost and resource constraints, as well as contextual factors.
The intervention has the potential to improve public health and community practice by making empirically supported treatment techniques more available in CMHCs and improving the efficiency of treatment delivery by integrating computerized and therapist delivered approaches. Specifically, this study has the potential to advance treatment by: 1) understanding factors that enhance or impede computer assisted parent training in the community setting; 2) addressing a high-needs underserved population with significant public health relevance; 3) engaging the target mechanism of therapist fidelity, competency, and alliance as well as parenting skills and self-efficacy that have been shown to influence adolescent behavior problems; 4) increasing access to and engagement in an evidence-based treatment that can be personalized to the specific parenting skills of a family by the selection of modules in PW; and 5) enhancing the ease of dissemination and implementation. Furthermore, we believe this approach has the potential for improving response rate, because the parenting skills will be delivered with greater fidelity than would be typical of therapists teaching parenting in sessions in CHMCs. This improvement should also result in an improved response in adolescent behavior. We believe this is true because: 1) meta-analyses typically report moderate effect sizes for parent training at the end of treatment; 2) parent training is underemployed in community clinics; 3) fidelity to treatment protocols is often poor which has been shown to diminish effectiveness of treatment; and 4) frequent staff turnover creates high resource demands. Thus, we believe this approach is not only efficient but that there is potential for significant improvements in efficacy of parent training with this model.
- Conditions
- Parenting, Adolescent Problem Behavior
- Being tested
- Parenting Wisely
- Keywords
- Parenting skills, Computer-based parenting program, Parenting Wisely, Adolescent disruptive behavior disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting WiselyBehavioural
Also called PW
PW is a self-administered, interactive, multimedia online program. Parents will complete computer-administered sessions during in-person appointments.The program comes with a parent workbook so that parents can gain additional exposure to and practice with the skills. The complete PW program takes from 3 to 5 hours to complete depending on the users' speed and depth of use. Parents will be given a login at enrollment so that they have the option to practice sessions or view any additional sessions at home. Individual coaching sessions will take place in-person with parents. Coaching sessions are designed to tailor the PW skills to each parent's presenting concerns.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | The TAU condition consists of the standard treatment elements offered to all Gateway (study site) patients, and will be received by patients in both the PW and the TAU-only condition. TAU services during the adolescent's treatment are typically eclectic and mainly entail meeting with the adolescent alone to provide support and psychoeducation, with occasional family therapy sessions. Medication management is offered as needed. |
| Parenting Wisely (PW) | Experimental | In addition to TAU services, the PW arm includes in-person sessions where parents complete computer-administered PW sessions, in-person session including therapist coaching to reinforce PW material and personalize treatment by applying PW skills to individual issues, and access to PW material remotely so parents can access information and skills from home as needed. Receives: Behavioral: Parenting Wisely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire-Patient Version
The PCTQ-P is an instrument for assessing consumers' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 sub-scales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.
Measured: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months
Consumer Satisfaction Questionnaire
The CSQ asks parents to rate their satisfaction with treatment delivery, their child's treatment progress, and their ability to manage their child's problems. Parents rate 11 items along a 7-point scale and answer 5 open-ended questions about their experience in treatment
Measured: 3 months after start of intervention
Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire- Clinician Version
an instrument for assessing clinicians' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 subscales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.
Measured: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 3 months and 6 months
Change in Evidence-Based Practice Attitude Scale
A 15 question reliable tool to evaluate the attitudes of providers who specialize in child and adolescent mental health toward Evidence Based Practice.
Measured: Change from Baseline Evidence-Based Practice Attitude Scale at 3 months and 6 months
Change in Perceived Characteristics of Intervention Scale
The PCIS is a 20 question reliable assessment measure of perceived characteristics of interventions, and will be specified towards the intervention, Parenting Wisely.
Measured: Change from Baseline Perceived Characteristics of Intervention Scale at 3 months and 6 months
Change in Qualitative Interviews
Qualitative feedback from interviews with parents, providers, and program managers will also be conducted. All quaAlitative interviews will be videotaped, transcribed verbatim and coded for nonverbal behaviors in addition to verbal content. We will use an interview guide to ensure the adequacy and quality of data. The guide will be refined to reflect unanticipated topics that arise and integrate these emergent topics and questions[40]. We will approach the interview as a collaborative process with participants and interviewers will encourage each participant to talk freely about the therapeutic process, coverage of parenting skills, and topic areas in PW. Broad questions will be followed by probes and unstructured questions based on areas raised by participants to encourage elaboration and clarification but limit influence from the interviewer.
Measured: Change from Baseline Qualitative Interviews at 3 months and 6 months
Change in Pediatric Symptom Checklist
A well-known measure to help primary care providers assess the likelihood of finding any mental health disorder in their patient. The questionnaire consists of 17 items on behavior or emotional problems.
Measured: Change from Screening Pediatric Symptom Checklist at 3 months and 6 months
Secondary outcomes (9)
Parent Monitoring Questionnaire
The PMQ is a 24 item youth and parent report measure designed to assess parental monitoring and sources of parental knowledge. The monitoring subscale has demonstrated good reliability (alpha = .82 parents, .85 youth) and correlates with adolescent internalizing and externalizing maladjustment, deviant peer relationships, and family discord.
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
McMaster Family Assessment Device
This measure includes the following sub-scales assessing parenting skills: Problem Solving (i.e., the family's ability to resolve problems in ways that maintain effective family functioning.); Family Roles (i.e., the extent to which tasks are clearly and equitably distributed among family members); Communication (i.e., the extent to which verbal messages between family members are clear); Affective Involvement (i.e., the extent to which family members are interested in and placed value on each other's activities); Affective Responsiveness (i.e., the extent to which family members experience appropriate affect in response to stimuli); Behavioral Control (i.e., the extent to which the family expresses and maintains standards for the behavior of its members). All items are rated on a 4-point scale and the sub-scales have adequate reliability.
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Parent-Adolescent Communication Scale
The PACS is a youth and parent report measure that assesses positive and negative aspects of general parent-teen communication and the content and process of parent-teen interactions. The two sub-scales have good reliability (alpha = .77 - .88) and have been shown to correlate with teen engagement in problem behavior.
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Parenting Self Efficacy
This 10-item scale assesses the degree of parents' confidence in implementing specific parenting skills.
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
FAsTask Video Code
The FAsTask is a video-taped family problem solving task that will be used to provide an in-vivo assessment of parenting behaviors. We have limited the assessment to tasks that align with our primary aims. Specifically, parent-teen dyads will be prompted to spend 5 minutes on each of the following: 1) teen leads a discussion about a time without supervision and parents seek additional information (monitoring and listening); 2) parents lead a discussion on setting limits over the previous month (limit setting) and then communicate rules to the teen; 3) parents and teens problem solve around an issue; and 4) positive recognition when the parent praises the teen.
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Issues Checklist
This measure will work to decipher distressed families versus non distressed families and addressing and identifying the issues.
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Disruptive Behavior Disorder Rating Scale
The DBDRS which is comprised of the DSM symptom lists for ADHD, ODD, and CD. It uses a 4-point response scale completed by parents for questions regarding ADHD and ODD and a yes/no format for CD symptoms to assess behavior problems within the past month. The DBDRS has been shown to have excellent psychometric properties
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Child and Adolescent Services Assessment (CASA)
This is a semi structured interview for parents and teens/children to assess service utilization for emotional, behavioral, and substance use problems. It addresses a range of services including inpatient, emergency room services, residential treatment centers, detention centers, probation, foster home services, hospitalization, in-home services, family therapy and outpatient services. The teen will complete questions regarding services related to school including boarding school, therapeutic/behavioral school, school support and school professional services
Measured: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Working Alliance Inventory
The WAI is an 11-item measure in which parents are asked to rate their alliance with their therapists on a 7-point Likert scale. This measure examines factors such as having a collaborative approach to treatment, perceived expertise, trust, and establishing shared goals.
Measured: 3 months after start of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start29 Oct 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the Open Trial, all participants will receive PW. In the RCT phase, adolescents will be randomly assigned to one of the two conditions. After completion of the baseline assessment, random assignment of adolescents using blocking and stratification will be automatically generated by the electronic data capture software REDCap. Random block sizes of assignments will be generated to prevent guessing of pending treatment assignments. Stratification will be used to ensure a balance on biological sex and disruptive behavior disorder severity (more of less than T=85), as indicated on the CBCL.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Wolff, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751345
- Sponsor's protocol ID
- 1R34MH113598-01A1
- Status last verified
- Nov 2018
- First submitted
- 2 Oct 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Computer-Assisted Parent Training Therapy Into Community Mental Health Clinic Practice
- ClinicalTrials.gov ID
- NCT03751345
- Acronym / sponsor ID
- 1R34MH113598-01A1
- Conditions
- Parenting, Adolescent Problem Behavior
- Keywords
- Parenting skills, Computer-based parenting program, Parenting Wisely, Adolescent disruptive behavior disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a low-cost, low-intensity, computer-based model for delivering parenting skills to parents of adolescents in a community mental health clinic. This intervention has the potential to improve public health and community practice by making empirically-supported treatment techniques more available. We believe this approach will improve the efficiency of treatment delivery by integrating computerized and therapist delivered approaches, and there is potential for significant improvements in efficacy of parent training with this model.
Detailed description
This study will evaluate a low cost, low intensity, technology based model for delivering parenting skills to parents of adolescents in a community mental health clinic (CMHC). Specifically, we will test a computer-assisted protocol of Parenting Wisely, a computer based parenting program with previously established efficacy. Such an intervention is consistent with NIMH strategic plan objective 3.3: "to strengthen the application of mental health interventions in diverse care settings by examining community and intervention delivery approaches and how they may affect intervention outcomes." Although this is a pilot effectiveness study, we will gather information to inform future implementation efforts including the feasibility and acceptability of the intervention. Additionally, we will conduct qualitative interviews with relevant stakeholders (providers/program managers) to better understand barriers and facilitators of adoption and sustainability. This goal will help increase the likelihood of a successful, future larger trial across multiple CMHCs due to its focus on external validity and implementation barriers when making critical design decisions. This approach mitigates a major criticism of traditional efficacy/effectiveness studies, i.e. that the methods do not translate well to the community due to cost and resource constraints, as well as contextual factors.
The intervention has the potential to improve public health and community practice by making empirically supported treatment techniques more available in CMHCs and improving the efficiency of treatment delivery by integrating computerized and therapist delivered approaches. Specifically, this study has the potential to advance treatment by: 1) understanding factors that enhance or impede computer assisted parent training in the community setting; 2) addressing a high-needs underserved population with significant public health relevance; 3) engaging the target mechanism of therapist fidelity, competency, and alliance as well as parenting skills and self-efficacy that have been shown to influence adolescent behavior problems; 4) increasing access to and engagement in an evidence-based treatment that can be personalized to the specific parenting skills of a family by the selection of modules in PW; and 5) enhancing the ease of dissemination and implementation. Furthermore, we believe this approach has the potential for improving response rate, because the parenting skills will be delivered with greater fidelity than would be typical of therapists teaching parenting in sessions in CHMCs. This improvement should also result in an improved response in adolescent behavior. We believe this is true because: 1) meta-analyses typically report moderate effect sizes for parent training at the end of treatment; 2) parent training is underemployed in community clinics; 3) fidelity to treatment protocols is often poor which has been shown to diminish effectiveness of treatment; and 4) frequent staff turnover creates high resource demands. Thus, we believe this approach is not only efficient but that there is potential for significant improvements in efficacy of parent training with this model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the Open Trial, all participants will receive PW. In the RCT phase, adolescents will be randomly assigned to one of the two conditions. After completion of the baseline assessment, random assignment of adolescents using blocking and stratification will be automatically generated by the electronic data capture software REDCap. Random block sizes of assignments will be generated to prevent guessing of pending treatment assignments. Stratification will be used to ensure a balance on biological sex and disruptive behavior disorder severity (more of less than T=85), as indicated on the CBCL.
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –The TAU condition consists of the standard treatment elements offered to all Gateway (study site) patients, and will be received by patients in both the PW and the TAU-only condition. TAU services during the adolescent's treatment are typically eclectic and mainly entail meeting with the adolescent alone to provide support and psychoeducation, with occasional family therapy sessions. Medication management is offered as needed. |
| Parenting Wisely (PW) | Experimental | Behavioral: Parenting WiselyIn addition to TAU services, the PW arm includes in-person sessions where parents complete computer-administered PW sessions, in-person session including therapist coaching to reinforce PW material and personalize treatment by applying PW skills to individual issues, and access to PW material remotely so parents can access information and skills from home as needed. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- be the parent or legal guardian of an adolescent aged 12-17 years
- have an adolescent with clinically elevated disruptive behaviors as indicated by parent report on the Child Behavior Checklist (CBCL; Achenbach, 2000; Aggressive Problems or Oppositional/Defiant Problems T score > 70)
- be willing to receive a parenting intervention
- be fluent in English or Spanish
- be willing to provide written consent and teen willing to provide written assent
Key exclusion criteria (1 listed)
- severe clinical presentations, such as psychosis or developmental delay, at a level that would interfere with the ability to assent or complete assessments
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 |
|---|---|---|
| Parenting WiselyAlso: PWPW is a self-administered, interactive, multimedia online program. Parents will complete computer-administered sessions during in-person appointments.The program comes with a parent workbook so that parents can gain additional exposure to and practice with the skills. The complete PW program takes from 3 to 5 hours to complete depending on the users' speed and depth of use. Parents will be given a login at enrollment so that they have the option to practice sessions or view any additional sessions at home. Individual coaching sessions will take place in-person with parents. Coaching sessions are designed to tailor the PW skills to each parent's presenting concerns. | Behavioural | Parenting Wisely (PW) |
Primary outcome
Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire-Patient Version
Time frame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months
The PCTQ-P is an instrument for assessing consumers' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 sub-scales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.
Consumer Satisfaction Questionnaire
Time frame: 3 months after start of intervention
The CSQ asks parents to rate their satisfaction with treatment delivery, their child's treatment progress, and their ability to manage their child's problems. Parents rate 11 items along a 7-point scale and answer 5 open-ended questions about their experience in treatment
Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire- Clinician Version
Time frame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 3 months and 6 months
an instrument for assessing clinicians' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 subscales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.
Change in Evidence-Based Practice Attitude Scale
Time frame: Change from Baseline Evidence-Based Practice Attitude Scale at 3 months and 6 months
A 15 question reliable tool to evaluate the attitudes of providers who specialize in child and adolescent mental health toward Evidence Based Practice.
Change in Perceived Characteristics of Intervention Scale
Time frame: Change from Baseline Perceived Characteristics of Intervention Scale at 3 months and 6 months
The PCIS is a 20 question reliable assessment measure of perceived characteristics of interventions, and will be specified towards the intervention, Parenting Wisely.
Change in Qualitative Interviews
Time frame: Change from Baseline Qualitative Interviews at 3 months and 6 months
Qualitative feedback from interviews with parents, providers, and program managers will also be conducted. All quaAlitative interviews will be videotaped, transcribed verbatim and coded for nonverbal behaviors in addition to verbal content. We will use an interview guide to ensure the adequacy and quality of data. The guide will be refined to reflect unanticipated topics that arise and integrate these emergent topics and questions[40]. We will approach the interview as a collaborative process with participants and interviewers will encourage each participant to talk freely about the therapeutic process, coverage of parenting skills, and topic areas in PW. Broad questions will be followed by probes and unstructured questions based on areas raised by participants to encourage elaboration and clarification but limit influence from the interviewer.
Change in Pediatric Symptom Checklist
Time frame: Change from Screening Pediatric Symptom Checklist at 3 months and 6 months
A well-known measure to help primary care providers assess the likelihood of finding any mental health disorder in their patient. The questionnaire consists of 17 items on behavior or emotional problems.
9 secondary outcomes
Parent Monitoring Questionnaire
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
McMaster Family Assessment Device
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Parent-Adolescent Communication Scale
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Parenting Self Efficacy
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
FAsTask Video Code
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Issues Checklist
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Disruptive Behavior Disorder Rating Scale
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Child and Adolescent Services Assessment (CASA)
Time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Working Alliance Inventory
Time frame: 3 months after start of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Altemus, BA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Wisely in people with Parenting and Adolescent Problem Behavior, run by Rhode Island Hospital at 1 site 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 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Wolff, PhD (401-444-3790, jwolff2@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire-Patient Version (time frame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.