Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers

NCT03916146 | Active Not Recruiting Results DMC

• 2 other identifiers: 45213R01DC016957
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.

Conditions

Deafness; Hearing Loss; Parenting; Child Behavior

Outcome Measures

Primary Outcomes (1)

• Parenting Young Children (PARYC) Scale Total Score

  On the Parenting Young Children (PARYC) scale, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.

  6 months after parent baseline

Secondary Outcomes (26)

• Change in Parenting Young Children Scale (PARYC) Total Scores Over Time

  Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

• Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time

  Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

• Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time

  Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

• Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time

  Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

• Child Behavior Checklist (CBCL) Total Problems T-Score

  Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

Other Outcomes (16)

• MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)

  Annually from baseline through up to 36 months.

• MacArthur Bates Communicative Development Inventories - Words & Sentences - Sentence Complexity Score

  Annually from baseline through up to 36 months.

• Peabody Picture Vocabulary Test (PPVT) Standard Score

  Annually from baseline assessment through up to 36 months after baseline

Study Arms (2)

Behavioral Parent Training

EXPERIMENTAL

Parents are offered a evidence-based behavioral parent training intervention systematically adapted for parents of young deaf and hard of hearing children. The intervention is offered annually and includes up to 6 sessions each year.

Behavioral: Parent Training Intervention

Control

NO INTERVENTION

Parents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren.

Interventions

Parent Training Intervention BEHAVIORAL

Adapted version of the Family Check-Up/Everyday Parenting intervention

Behavioral Parent Training

Eligibility Criteria

• Age: 3 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent is age 18 or older
• Parent is custodial guardian of child
• Parent can either speak/understand English or use American Sign Language
• Parent lives in a state with an established referral network for parents of DHH children if additional services are needed
• At baseline, child is between the ages of 3 and 6 years
• At baseline, child lives majority of time in the parent/guardian's home
• Child is deaf or hard of hearing
• Child has used hearing aid(s), cochlear implant(s) and/or bone conduction device(s) for greater than 6 months

You may not qualify if:

• Active child protective services case is open
• Parent has already accessed behavioral health services for the child
• Parent participated in formative research for this study

Sponsors & Collaborators

• Christina Studts: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Deafness; Hearing Loss; Child Behavior

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Christina Studts
• Organization: University of Colorado - Anschutz Medical Campus

christina.studts@cuanschutz.edu

303-724-2495

Study Officials

• Christina Studts, PhD, MSPH, MSW

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Julie Lowman, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: June 17, 2021
• Primary Completion: October 14, 2024
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 3, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
• Access Criteria: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.

Locations

US (1)