Computerized Parenting Intervention

Parenting Clinical Trial

Official title:

Integrating Computer-Assisted Parent Training Therapy Into Community Mental Health Clinic Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751345
• Other study ID #: 1R34MH113598-01A1
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: May 2021

Study information

• Verified date: November 2018
• Source: Rhode Island Hospital
• Contact: Jennifer Wolff, PhD
• Phone: 401-444-3790
• Email: jwolff2[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• severe clinical presentations, such as psychosis or developmental delay, at a level that would interfere with the ability to assent or complete assessments

Related Conditions & MeSH terms

• Adolescent Problem Behavior
• Parenting
• Problem Behavior

Intervention

Behavioral:
• Parenting Wisely
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.

Locations

Country	Name	City	State
United States	Gateway Healthcare Inc	Pawtucket	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months
Primary	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	3 months after start of intervention
Primary	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.	Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 3 months and 6 months
Primary	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.	Change from Baseline Evidence-Based Practice Attitude Scale at 3 months and 6 months
Primary	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.	Change from Baseline Perceived Characteristics of Intervention Scale at 3 months and 6 months
Primary	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.	Change from Baseline Qualitative Interviews at 3 months and 6 months
Primary	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.	Change from Screening Pediatric Symptom Checklist at 3 months and 6 months
Secondary	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.	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	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.	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	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.	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	Parenting Self Efficacy	This 10-item scale assesses the degree of parents' confidence in implementing specific parenting skills.	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	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.	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	Issues Checklist	This measure will work to decipher distressed families versus non distressed families and addressing and identifying the issues.	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	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	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	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	Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
Secondary	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.	3 months after start of intervention.