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- Klinische proef NCT02330666
Parent-child Communication and Health-risk Behavior (MP)
30 september 2015 bijgewerkt door: University of Wisconsin, Madison
Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society.
Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been found to be protective against a youth's involvement in health-risk behaviors.
To promote positive adult-youth communication, in earlier work we developed, tested, and found efficacious an intervention, Mission Possible: Parents and Kids Who Listen (MP).
This study is designed to test the following hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive communication when compared with adults who did not participate; (b) Youth who participate in MP will have a lower incidence of health-risk behavior when compared with youth who did not participate; and (c) Positive adult-youth communication will mediate childhood health-risk behavior in the presence of risk processes that predict participation.
The experimental design is a 2-group (intervention and comparison) pre-test repeated measures design with six waves of data collection over three years and two booster sessions of the intervention.
Elementary school and community centers in Madison and Chicago served as recruitment sites for parent-child dyads.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
604
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
10 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Adults and youth must be English speakers
- Youth must be 10 years old
Exclusion Criteria:
- Severe mental or physical illness that could preclude involvement in data collection procedures
- Family plans to move from the metropolitan areas prior to study completion
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Geen tussenkomst: Comparison
Standard care
|
|
Experimenteel: Intervention
Communication skills training Mission Possible: Parents & Kids Who Listen
|
MP is a 12-hour, 6-session, manualized skills training program with 2 boosters.
Behavioral strategies teach adults and youth to communicate with one another emphasizing youth's need for flexible family boundaries, emotional closeness, and adults as resources.
Dyads attend together.
Sessions begin with relaxation exercises, review of the prior week's lessons and homework, and examination of success and failure in trying communication techniques.
New concepts are introduced using didactic videotaped presentations.
Lively, interactive, developmentally appropriate group exercises follow reflective of ethnic diversity that are reinforced with handouts and encouragement to try them at home.
Week-by-week content covers: Developmental Changes; Self-Esteem; Communicating What You Want; Listening to What the Other Wants; Solving Conflicts; and Letting Go.
The booster sessions are 2 hours in length and update developmental concepts; 5 basic listening skills; and 6 conflict resolution steps.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Youth Health Risk Behavior
Tijdsspanne: 3 years
|
Measured with the 22-item Children's Health Risk Behavior Scale (CHRBS).
This instrument, based on the conceptual categories of the Youth Risk Behavioral Surveillance Survey, assesses potential for unintentional and intentional injury or violence, tobacco use, alcohol and other drug use, sexual curiosity, and health practices.
|
3 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Openness of Communication
Tijdsspanne: 3 years
|
The Parent Adolescent Communication Inventory (Olson, 1983) is a 20-item, 2-subscale (open or problem communication) self-report instrument with a youth version and an adult version, the difference being the target of the item - mother/father or youth.
Scores are computed for adult communication, youth-mother communication, youth-father communication.
|
3 years
|
Family Satisfaction
Tijdsspanne: 3 years
|
The Family Adaptability and Cohesion Evaluation Scale III is a 20-item, self-report instrument (Olson, 1994) to measure family satisfaction.
Participants answer the items twice, first to assess current and then to assess ideal family system conditions.
The difference between ideal and perceived conditions yields a family satisfaction score.
|
3 years
|
Problem-Solving Skill
Tijdsspanne: 3 years
|
50% of the dyads were randomly selected for assessment of problem solving ability.
The procedure was to (a) identify a problem for discussion from the Issues Checklist (IC), (b) videotape the dyad attempting to solve the problem identified, and (c) code the videotaped interaction using the Iowa Family Interaction Rating Scales (IFIRS).
The IFIRS is a macro-level observational coding system that was initially developed in 1989 and has undergone 5 revisions.
Scales used to assess three aspects of family interaction were: (a) individual behavioral characteristics or each person's generalized interaction consisting of 8 items, e.g., use of humor, mood, whining and complaining; (b) dyadic behavioral characteristics or the nature of behavior exchanged from one family member to another consisting of 22 items, e.g., hostility, warmth/support; and (c) the family problem-solving process consisting of 10 items, e.g., solution quality, family enjoyment.
|
3 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Susan K Riesch, PhD, University of Wisconsin, Madison
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2004
Primaire voltooiing (Werkelijk)
1 februari 2010
Studie voltooiing (Werkelijk)
1 december 2010
Studieregistratiedata
Eerst ingediend
30 december 2014
Eerst ingediend dat voldeed aan de QC-criteria
31 december 2014
Eerst geplaatst (Schatting)
5 januari 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
2 oktober 2015
Laatste update ingediend die voldeed aan QC-criteria
30 september 2015
Laatst geverifieerd
1 september 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2003-352
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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