Clinical trial NCT03751345: Computerized Parenting Intervention
Official title: Integrating Computer-Assisted Parent Training Therapy Into Community Mental Health Clinic Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Adolescent Problem Behavior
Keywords: Parenting skills
Computer-based parenting program
Parenting Wisely
Adolescent disruptive behavior disorders
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire-Patient Version
timeFrame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months
measure: Consumer Satisfaction Questionnaire
timeFrame: 3 months after start of intervention
measure: Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire- Clinician Version
timeFrame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 3 months and 6 months
measure: Change in Evidence-Based Practice Attitude Scale
timeFrame: Change from Baseline Evidence-Based Practice Attitude Scale at 3 months and 6 months
measure: Change in Perceived Characteristics of Intervention Scale
timeFrame: Change from Baseline Perceived Characteristics of Intervention Scale at 3 months and 6 months
measure: Change in Qualitative Interviews
timeFrame: Change from Baseline Qualitative Interviews at 3 months and 6 months
measure: Change in Pediatric Symptom Checklist
timeFrame: Change from Screening Pediatric Symptom Checklist at 3 months and 6 months
Secondary outcomes:
measure: Parent Monitoring Questionnaire
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: McMaster Family Assessment Device
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: Parent-Adolescent Communication Scale
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: Parenting Self Efficacy
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: FAsTask Video Code
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: Issues Checklist
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: Disruptive Behavior Disorder Rating Scale
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: Child and Adolescent Services Assessment (CASA)
timeFrame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
measure: Working Alliance Inventory
timeFrame: 3 months after start of intervention.
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Gateway Healthcare Inc
state: Rhode Island
Study officials:
References: