Encouraging Positive Parenting Habits

ADHD Clinical Trial

— HABITE  

Official title:

Encouraging Positive Parenting Habits Through Digital Media: Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06305429
• Other study ID #: HABITE
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study.

Description:

This feasibility study employs a pre-post, open trial design with the primary aim to investigate the feasibility of the automated delivery of parenting educational materials via a widely used texting platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through daily interactions of the participants with the program and post-program questionnaires. The study targets parents of children demonstrating behavioral difficulties managing everyday routines at home, while having difficulty accessing traditional forms of psychosocial treatment. In particular, children of ADHD often experience these difficulties, potential participants are informed that the program is for children demonstrating behaviors consistent with ADHD, and ADHD symptoms will be evaluated pre- and post-program participation, although the presence of the disorder will not be required for the program participation. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, the investigators expect a moderate effect size in the pre-post measures of parenting practices and the child target behavior for this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Parents of children aged from 4 to 10 years old
• Parents experiencing behavior difficulties with daily transition routines (parent-report).

Exclusion Criteria:

• Parents that do not have the children living with them at least 5 days per week every week;
• While participating parents are informed that the program was developed for children demonstrating symptoms of ADHD, the low symptom number will not be used as an exclusion criteria.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• HabitE (effective parenting habit) program (in Brazilian Portuguese)
Parents who enroll in the program will receive a series of 6 videos (~ 7 minutes each), 1 video at a time, generally every 3 days. They will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Okinawa Institute of Science and Technology Graduate University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ADHD symptoms	Strengths and Weakness of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) inattention and hyperactivity/impulsivity symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 18 items. Higher scores indicate ADHD symptoms more frequently observed.	1 month
Other	ODD symptoms	SWAN oppositional/defiant symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 8 items. Higher scores indicate ODD symptoms more frequently observed.	1 month
Other	Irritability	Affective Reactivity Index (ARI). Parent ratings completed before and after the intervention using a 3-point scale. Averaged across 6 items. Higher scores indicate irritability more frequently observed.	1 month
Other	Proactive parenting	MAPS Proactive Parenting subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 6 items. Lower scores indicate less frequent incidents of inconsistent parenting.	1 month
Other	Use of positive reinforcement	MAPS Positive Reinforcement subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 4 items. Lower scores indicate less frequent use of physical disciplines.	1 month
Primary	Number of videos viewed	The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement	1 month
Primary	Percentage of completed daily ratings	The percentage of completed daily ratings (minimum 0, maximum 17). Parents are asked to provide daily ratings on the degree of success in implementing parenting strategies taught.	1 month
Primary	Participant satisfaction	The parent-rated satisfaction regarding information presented in the videos. A rating completed after each video viewing using a 4-point scale. Averaged across the ratings completed for the videos viewed. (Minimum 0, maximum 4). Higher scores indicate greater satisfaction.	1 month
Secondary	Parent-rated child's difficulties with daily transitions	The parent-rated child's difficulties with 9 common daily transitions. Ratings completed before and after the intervention using a 3-point scale. Averaged across the ratings completed for the 9 transitions. Higher scores indicate greater difficulties.	1 month
Secondary	Parent-rated child's impairment related to transition difficulties	The parent-rated level of impairment caused by transition difficulties (1 item). Ratings completed before and after the intervention using a 7 point scale. Higher scores indicate greater impairment.	1 month
Secondary	Inconsistent parenting	Multidimensional Assessment of Parenting Scale (MAPS) Lax Control subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 6 items. Lower scores indicate less frequent incidents of inconsistent parenting.	1 month
Secondary	Use of physical control	MAPS Physical Control. Parent ratings completed before and after the intervention using a 5-point scale. Average across 4 items. Lower scores indicate less frequent use of physical disciplines.	1 month
Secondary	Hostility toward child	MAPS Hostility subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 7 items. Lower scores indicate less frequent use of hostile reactions during parent-child interactions.	1 month
Secondary	Parent Stress	Parent stress scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 18 items. Lower scores indicate lower levels of stress.	1 month