Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships

Parenting Clinical Trial

Official title:

Online Parent Media Literacy Program to Promote Preadolescent Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408818
• Other study ID #: TweenHealthStudy-R21-23-006-01
• Secondary ID: 5R21HD108440-02
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Innovation Research & Training
• Contact: Tracy M Scull, PhD
• Phone: 9194937700
• Email: tscull[@]irtinc.us
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to learn if Media Aware Parent - Tween, an online program for parents of children ages 9-12, helps parents have effective conversations with their child about health and media.

Description:

Parent-child pairs (N=300 pairs) will be recruited to participate in a randomized controlled trial. Parent consent and parent permission and youth assent will be sought. Participant pairs will be randomized into one of two study arms: intervention and active control. All participants will complete a web-based pre-test questionnaire. Youth and parents will then receive access to their randomly assigned resource. Approximately four weeks after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• The adult must be the legal guardian of a child ages 9 to 12 years old.

• The parent must be able and willing to receive email and text communication as part of the study.

• The parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone.

• The parent-child pair must be fluent in English as the study materials are written in English.

• The parent must indicate that they will give the child participant privacy to complete the questionnaires.

• Both the adult and child must agree to participate.

Exclusion Criteria:

• Only one parent-child pair per family may participate in the study. If the parent has more than one child aged 9 to 12 that is willing to participate, the parent will be prompted to select the child participant based on the following: if the parent's last name begins with a letter from A to M, select the youngest eligible child willing to participate or if the parent's last name begins with a letter from N to Z, select the oldest eligible child willing to participate.

• In an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study.

Related Conditions & MeSH terms

• Communication
• Parent-Child Relations
• Parenting

Intervention

Behavioral:
• Media Aware Parent - Tween
Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
• Active Control Resource
Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Locations

Country	Name	City	State
United States	innovation Research and Training	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Innovation Research & Training	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pretest in child report of frequency of parent-child communication	Child will respond to questions about the frequency with which their parent has talked with them about 12 topics related to prepubescent health on a Likert-type scale [Never; A little; A lot]	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in parent report of frequency of parent-child communication	Parent will respond to questions about the frequency with which they have talked with their child about 12 topics related to prepubescent health on a Likert-type scale [Never; A little; A lot]	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in child report of general parent-child communication quality	Child will indicate the extent to which they agree with nine statements about communication with their parent on a Likert-type scale [Strongly disagree, Disagree, Agree, Strongly agree]	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in parent report of general parent-child communication quality	Parent will indicate the extent to which they agree with nine statements about communication with their child on a Likert-type scale [Strongly disagree, Disagree, Agree, Strongly agree]	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in child report of parental media mediation	Parents' use of media mediation strategies will be assessed including: evaluative mediation of television and restrictive mediation of television, and similar scales for video games and the Internet. Participants will indicate using a Likert scale how often their parent engages in specific media mediation and restriction behaviors. Adapted from Valkenburg et al., (1999).	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in parent report of parental media mediation	Parents' use of media mediation strategies will be assessed including: evaluative mediation of television and restrictive mediation of television, and similar scales for video games and the Internet. Participants will indicate using a Likert scale how often they engage in specific media mediation and restriction behaviors. Adapted from Valkenburg et al., (1999).	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in child report of awareness of family media rules	Child will indicate on one item whether their family has rules about media use (Scull et al., 2019). Response options are "yes," "no," and "unsure".	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in parent report of awareness of family media rules	Parent will indicate on one item whether their family has rules about media use (Scull et al., 2019). Response options are "yes," "no," and "unsure".	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in child report of acceptance of gender stereotypical roles	Child will respond to the 7 items to indicate their agreement with statements about gender using a 5-point Likert scale ("disagree a lot" to "agree a lot").	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in child report of attitudes toward puberty	Child will respond to items (e.g., "I feel ashamed of my body when I have my period") on a 4-point scale from 1 = disagree a lot to 4 = Agree a lot to assess participants' attitudes towards puberty. Adapted from the Puberty scale from the Global Early Adolescent Study (2011).	Pretest and Posttest (about four weeks after pretest questionnaire completion)
Primary	Change from pretest in child report of body-esteem	Child will respond to four statements about how they feel about their body (e.g., I'm proud of my body) on a 5-point scale [Never; Seldom; Sometimes; Often; Always]. Adapted from Mendelson et al., 2002.	Pretest and Posttest (about four weeks after pretest questionnaire completion)