Computerized Parenting Intervention

NCT03751345 | Unknown

• 1 other identifier: 1R34MH113598-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Adolescent Problem Behavior

Keywords

Parenting skills; Computer-based parenting program; Parenting Wisely; Adolescent disruptive behavior disorders

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Parent Monitoring Questionnaire

  Baseline assessment, 3 months after start of intervention, 6 months after start of intervention

• McMaster Family Assessment Device

  Baseline assessment, 3 months after start of intervention, 6 months after start of intervention

• Parent-Adolescent Communication Scale

  Baseline assessment, 3 months after start of intervention, 6 months after start of intervention

• Parenting Self Efficacy

  Baseline assessment, 3 months after start of intervention, 6 months after start of intervention

• FAsTask Video Code

  Baseline assessment, 3 months after start of intervention, 6 months after start of intervention

Study Arms (2)

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.

Behavioral: Parenting Wisely

Interventions

Parenting Wisely BEHAVIORAL

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.

Also known as: PW

Parenting Wisely (PW)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Gateway Healthcare Inc

Pawtucket, Rhode Island, 02860, United States

RECRUITING

Central Study Contacts

Jennifer Wolff, PhD

CONTACT

401-444-3790; jwolff2@lifespan.org

Melanie Altemus, BA

CONTACT

MAltemus@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: November 23, 2018
• Study Start: October 29, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

US (1)